Certolizumab Pegol

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Desiree Van Der Heijde - One of the best experts on this subject based on the ideXlab platform.

  • induction of sustained clinical remission in early axial spondyloarthritis following Certolizumab Pegol treatment 48 week outcomes from c optimise
    Rheumatology and Therapy, 2020
    Co-Authors: R Landewe, Desiree Van Der Heijde, M Dougados, Filip Van Den Bosch, Xenofon Baraliakos, Karl Gaffney, Lars Bauer, B Hoepken, Natasha De Peyrecave
    Abstract:

    Achievement of remission is a key treatment goal for patients with axial spondyloarthritis (axSpA). C-OPTIMISE assessed achievement of sustained clinical remission in patients with axSpA, including radiographic (r) and non-radiographic (nr) axSpA, during Certolizumab Pegol (CZP) treatment, and subsequent maintenance of remission following CZP dose continuation, dose reduction or withdrawal. Here, we report outcomes from the first 48 weeks (induction period) of C-OPTIMISE, during which patients received open-label CZP. C-OPTIMISE (NCT02505542) was a two-part, multicenter, phase 3b study in adult patients with early axSpA (r-/nr-axSpA), including a 48-week open-label induction period followed by a 48-week maintenance period. Patients with active adult-onset axSpA, < 5 years’ symptom duration, and fulfilling Assessment of SpondyloArthritis international Society classification criteria, were included. During the induction period, patients received a loading dose of CZP 400 mg at weeks 0, 2, and 4, followed by CZP 200 mg every 2 weeks (Q2W) up to week 48. The main outcome of the 48-week induction period was the achievement of sustained clinical remission (defined as an Ankylosing Spondylitis Disease Activity Score [ASDAS] < 1.3 at week 32 and < 2.1 at week 36 [or vice versa], and < 1.3 at week 48). In total, 736 patients (407 with r-axSpA, 329 with nr-axSpA) were enrolled into the study. At week 48, 43.9% (323/736) of patients achieved sustained remission, including 42.8% (174/407) of patients with r-axSpA and 45.3% (149/329) with nr-axSpA. Patients also demonstrated substantial improvements in axSpA symptoms, MRI outcomes and quality of life measures. Adverse events occurred in 67.9% (500/736) of patients, of which 6.0% (44/736) were serious. Over 40% of patients with early axSpA achieved sustained remission during 48 weeks of open-label CZP treatment. Additionally, patients across the axSpA spectrum demonstrated substantial improvements in imaging outcomes and quality of life following treatment. No new safety signals were identified. NCT02505542.

  • maintenance of clinical remission in early axial spondyloarthritis following Certolizumab Pegol dose reduction
    Annals of the Rheumatic Diseases, 2020
    Co-Authors: R Landewe, Desiree Van Der Heijde, O Davies, M Dougados, Filip Van Den Bosch, Xenofon Baraliakos, Karl Gaffney, Lars Bauer, B Hoepken, Natasha De Peyrecave
    Abstract:

    Background The best strategy for maintaining clinical remission in patients with axial spondyloarthritis (axSpA) has not been defined. C-OPTIMISE compared dose continuation, reduction and withdrawal of the tumour necrosis factor inhibitor Certolizumab Pegol (CZP) following achievement of sustained remission in patients with early axSpA. Methods C-OPTIMISE was a two-part, multicentre phase 3b study in adults with early active axSpA (radiographic or non-radiographic). During the 48-week open-label induction period, patients received CZP 200 mg every 2 weeks (Q2W). At Week 48, patients in sustained remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) 3.5 at any time point) during the double-blind period. Results At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo. During Weeks 48 to 96, 83.7% (87/104), 79.0% (83/105) and 20.2% (21/104) of patients receiving the full maintenance dose, reduced maintenance dose or placebo, respectively, were flare-free (p Conclusions Patients with early axSpA who achieve sustained remission at 48 weeks can reduce their CZP maintenance dose; however, treatment should not be completely discontinued due to the high risk of flare following CZP withdrawal. Trial registration number NCT02505542, ClinicalTrials.gov.

  • 4 year results from the rapid psa phase 3 randomised placebo controlled trial of Certolizumab Pegol in psoriatic arthritis
    RMD Open, 2018
    Co-Authors: Desiree Van Der Heijde, Roy Fleischmann, A Deodhar, Lars Bauer, B Hoepken, Alice B Gottlieb, Oliver Fitzgerald, Dafna D Gladman, Oscar Irvinsellers, Majed Khraishi
    Abstract:

    Objective To report the efficacy, patient-reported, radiographic and safety outcomes of 4 years’ Certolizumab Pegol (CZP) treatment in patients with psoriatic arthritis (PsA). Methods RAPID-PsA (NCT01087788) was double-blind and placebo-controlled to Week 24, dose-blind to Week 48 and open-label (OL) to Week 216. Patients were randomised 1:1:1 to either placebo or CZP 200 mg every 2 weeks (Q2W) or 400 mg every 4 weeks (Q4W) (following 400 mg at Weeks 0/2/4). Patients randomised to CZP continued their assigned dose in the OL period. Patients randomised to placebo were re-randomised to CZP 200 mg Q2W or 400 mg Q4W (post-loading dose) at Week 16 (early escape) or after the double-blind phase. We present observed and imputed data; missing values were imputed using non-responder imputation (NRI) for categorical and last observation carried forward (LOCF) for continuous measures. Results 409 patients were randomised; 20% (54/273) of Week 0 patients randomised to CZP had prior anti-tumour necrosis factor (TNF) exposure; 67% (183/273) completed 216 weeks. By Week 48, 60.4% of patients achieved Disease Activity Index for Psoriatic Arthritis low disease activity or remission, which was maintained; 66.3% achieved these outcomes at Week 216 (NRI). At Weeks 48 and 216, 39.2% of patients achieved minimal disease activity (NRI). 75% reduction in Psoriasis Area and Severity Index responses were 65% and 52% at Weeks 48 and 216 (NRI). Total resolution rates for enthesitis, dactylitis and nail psoriasis, at 4 years, were 71%, 81% and 65%, respectively (LOCF). Structural damage progression was low over 4 years’ treatment. No new safety signals were identified after Week 96. Conclusions CZP efficacy in treating PsA was maintained over 4 years, in patients both with and without prior anti-TNF exposure, with no new safety signals identified.

  • a phase iii study evaluating continuation tapering and withdrawal of Certolizumab Pegol after one year of therapy in patients with early rheumatoid arthritis
    Arthritis & Rheumatism, 2017
    Co-Authors: Michael E Weinblatt, Desiree Van Der Heijde, R Van Vollenhoven, Daniel E Furst, B Vanlunen, Gerd R Burmester, Xavier Mariette, Vivian P Bykerk, Clifton O Bingham, C Ecoffet
    Abstract:

    Objective: For DMARD-naive, early rheumatoid arthritis patients who achieved sustained low disease activity (sLDA; DAS28[ESR]≤3.2 at both Weeks 40 and 52) after 1 year of treatment with Certolizumab Pegol (CZP 200mg Q2W+optimized MTX), we evaluated whether continuation of CZP as a standard (200mg Q2W+MTX) or reduced-frequency (200mg Q4W+MTX) dose was superior to stopping CZP (placebo+MTX) in maintaining LDA for 1 additional year. Methods: 293 patients from C-EARLY Period 1 were re-randomized 2:3:2 in Period 2 to CZP standard (n=84), reduced-frequency (n=127), CZP stopped (n=82). The primary endpoint was the percentage of patients who maintained LDA throughout Weeks 52–104 without flares. Hierarchical testing scheme: CZP standard versus CZP stopped, if p<0.05 achieved, then CZP reduced-frequency versus CZP stopped (non-responder imputation). Results: 36% fewer patients than projected achieved sLDA in Period 1 and were eligible for enrollment in Period 2. A higher proportion of CZP standard and reduced-frequency patients maintained LDA versus CZP stopped (48.8% [p=0.112], 53.2% [p=0.041; nominal p value, first hierarchical test not significant] versus 39.2%). Similar trends were observed for radiographic non-progression (change from baseline mTSS≤0.5; 79.2%, 77.9% versus 70.3%) and normative physical function (HAQ-DI≤0.5; 71.4%, 70.6% versus 57.0%). Safety profiles were similar between all groups, with no new safety signals identified for continuing CZP to Week 104. No deaths were reported. Conclusion: The study failed to meet its primary endpoint. However, there were no clinically meaningful differences between the standard or reduced-frequency doses of CZP+MTX; both more effectively controlled rheumatoid arthritis in comparison to CZP withdrawal. This article is protected by copyright. All rights reserved.

  • a phase iii study evaluating continuation tapering and withdrawal of Certolizumab Pegol after one year of therapy in patients with early rheumatoid arthritis
    Arthritis & Rheumatism, 2017
    Co-Authors: Michael E Weinblatt, Desiree Van Der Heijde, R Van Vollenhoven, Daniel E Furst, B Vanlunen, Gerd R Burmester, Xavier Mariette, Vivian P Bykerk, Clifton O Bingham, C Ecoffet
    Abstract:

    Objective: In disease-modifying antirheumatic drug–naive patients with early rheumatoid arthritis (RA) who had achieved sustained low disease activity (a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate of ≤3.2 at both week 40 and week 52) after 1 year of treatment with Certolizumab Pegol (CZP) at a standard dose (200 mg every 2 weeks plus optimized methotrexate [MTX]), we evaluated whether continuation of CZP treatment at a standard dose or at a reduced frequency (200 mg every 4 weeks plus MTX) was superior to stopping CZP (placebo plus MTX) in maintaining low disease activity for 1 additional year. Methods: A total of 293 patients from period 1 of our study were re-randomized 2:3:2 in period 2 to CZP at a standard dose (n = 84), CZP at a reduced frequency (n = 127), or placebo plus MTX (CZP stopped) (n = 82). The primary end point was the percentage of patients who maintained low disease activity throughout weeks 52–104 without flares. We used a hierarchical testing scheme, comparing CZP at a standard dose with CZP stopped. If P < 0.05 was achieved, then CZP at a reduced frequency was compared with CZP stopped (nonresponder imputation). Results: The 293 patients from period 1 represented 36% fewer patients than projected, yielding a smaller number of patients eligible for period 2. Higher proportions of patients treated with the standard and reduced frequency regimens maintained low disease activity than those who had stopped CZP (48.8% and 53.2%, respectively, versus 39.2% [P = 0.112 and P = 0.041, respectively; nominal P value, first hierarchical test not significant]). Similar trends were observed for radiographic nonprogression (change from baseline of ≤0.5 in modified Sharp/van der Heijde score; 79.2% and 77.9% of patients, respectively, versus 70.3%) and normative physical function (Health Assessment Questionnaire disability index score of ≤0.5; 71.4% and 70.6% of patients, respectively, versus 57.0%). Safety profiles were similar between all groups, with no new safety signals identified for continuing CZP to week 104. No deaths were reported. Conclusion: The study failed to meet its primary end point. However, there were no clinically meaningful differences between the standard and reduced frequency doses of CZP plus MTX; both controlled RA more effectively than stopping CZP.

William J Sandborn - One of the best experts on this subject based on the ideXlab platform.

  • exposure response relationship of Certolizumab Pegol and achievement of low disease activity and remission in patients with rheumatoid arthritis
    Clinical and Translational Science, 2020
    Co-Authors: Stephane Paul, William J Sandborn, Tore K Kvien, Arthur Kavanaugh, Hubert Marotte, Philippe Goupille, Marc De Longueville, Denis Mulleman, Niels Vande Casteele
    Abstract:

    Anti-tumor necrosis factor (anti-TNF) drugs are often prescribed for the treatment of rheumatoid arthritis (RA) and other immune-mediated inflammatory diseases. Although this treatment has been shown to be effective in many patients, up to 40% of patients do not achieve disease control. Drug concentration in plasma may be a factor affecting the observed variability in therapeutic response. In this study, we aimed to identify the plasma concentrations of the anti-TNF Certolizumab Pegol (CZP), associated with improvement in disease activity in patients with RA. Data were pooled from three randomized, controlled clinical trials with a combined total of 1,935 patients analyzed. Clinical outcomes of low disease activity (LDA) and remission were defined as Disease Activity Score in 28 joints with C-reactive protein (DAS28(CRP)) ≤ 2.7 and < 2.3, respectively. Quartile analysis results indicated that there may be an exposure-response relationship between CZP concentration and LDA/remission outcomes at weeks 12 and 24; the association was strongest for LDA (P < 0.05). Receiver operating characteristic (ROC) analysis showed that CZP concentrations ≥ 28.0 μg/ml at week 12, and ≥ 17.6 μg/ml at week 24, were associated with a greater likelihood of achieving LDA/remission outcomes. Although confirmatory studies are warranted to define the optimal CZP therapeutic range at weeks 12 and 24, these data indicate that CZP concentrations may be associated with improvement of disease activity.

  • long term safety of Certolizumab Pegol in rheumatoid arthritis axial spondyloarthritis psoriatic arthritis psoriasis and crohn s disease a pooled analysis of 11 317 patients across clinical trials
    RMD Open, 2019
    Co-Authors: Jeffrey R Curtis, William J Sandborn, Tore K Kvien, A Blauvelt, Xavier Mariette, Marc De Longueville, Cecile Gaujouxviala, Kevin L Winthrop, Ivo Huybrechts, Vivian P Bykerk
    Abstract:

    Objective To review long-term Certolizumab Pegol (CZP) safety across all approved indications: rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), psoriasis (PSO) and Crohn’s disease (CD). Methods Data were pooled across 49 UCB-sponsored CZP clinical trials (27 RA, one axSpA, one PsA, five PSO, 15 CD) to August 2017. Serious adverse events (SAEs) of interest (infections, malignancies, autoimmunity/hypersensitivity events, major adverse cardiovascular events (MACE), gastrointestinal (GI) perforations, psoriasis events, laboratory abnormalities) and deaths were medically reviewed by an external expert committee, using predefined case rules. Incidence rates (IRs)/100 patient-years (PY) are presented by indication; standardised mortality and malignancy rates were calculated using WHO/GLOBOCAN/SEER databases. Pregnancies with maternal CZP exposure are also reported. Results Of 11 317 CZP-treated patients across indications (21 695 PY CZP exposure; maximum: 7.8 years), infections were the most common SAEs (overall IR: 3.62/100 PY; IRs ranged from 1.50/100 PY(PSO) to 5.97/100 PY(CD)). The IR for malignancies was 0.82/100 PY, including lymphoma (0.06/100 PY). MACE and GI perforation IRs in CZP-treated patients were 0.47/100 PY and 0.08/100 PY and were highest in RA and CD, respectively. Patients with PSO had the lowest SAE rates. The incidence of deaths and malignancies aligned with expected general population data. Conclusion This extensive overview of the CZP safety profile in clinical trials, across all indications, provides large-scale confirmation of previous reports. No new safety signals or relevant non-disease-related laboratory abnormalities were identified. The study demonstrated some indication-specific differences in certain SAE rates that may be attributable to the underlying inflammatory disease.

  • effects of transient and persistent anti drug antibodies to Certolizumab Pegol longitudinal data from a 7 year study in crohn s disease
    Inflammatory Bowel Diseases, 2017
    Co-Authors: William J Sandborn, Razvan Arsenescu, Stefan Schreiber, Douglas C Wolf, Gordana Kosutic, Anita Afzali, Bincy Abraham, Scott D Lee, Gerry Parker, Alexandra Gutierrez
    Abstract:

    BACKGROUND Anti-drug antibodies (ADAbs) may decrease the efficacy of biologics and increase the risk of adverse events. A single positive test may not preclude further treatment because of variations in assays used, test timing, and patient variables. We evaluated the longitudinal patterns of immunogenicity during 7 years of antitumor necrosis factor-alpha drug Certolizumab Pegol (CZP) treatment for moderate-to-severe Crohn's disease. METHODS PRECiSE 3 patients (n = 595) received open-label CZP 400 mg every 4 weeks up to 7 years. CZP-ADAb expression, plasma CZP concentration, Harvey-Bradshaw Index, C-reactive protein, and fecal calprotectin concentrations were measured multiple times. Longitudinal data, examined for CZP-ADAb positivity and categorized as transient (with temporary/no effect on CZP concentration), persistent, or negative, were correlated with clinical and biological variables. RESULTS Of the CZP-ADAb-positive patients, 40 (22.6%) had transient CZP-ADAbs and 94 (77.4%) had persistent CZP-ADAbs. Demographic characteristics were similar between groups. Median C-reactive protein and fecal calprotectin were higher (P < 0.05 at some visits) and plasma CZP concentrations were significantly lower (P < 0.0001 at all visits) in the persistent CZP-ADAb-positive group relative to the CZP-ADAb-negative group. Transient CZP-ADAb-positive and CZP-ADAb-negative patients had similar plasma CZP, C-reactive protein, and fecal calprotectin concentrations. Median Harvey-Bradshaw Index scores and rates of adverse events were similar among groups. CONCLUSIONS This analysis demonstrates that persistent CZP-ADAb has negative effects on drug levels and efficacy, whereas transient expression may not. Serial measurements may be needed to characterize ADAb positivity. www.clinicaltrials.gov, Number NCT00160524.

  • accounting for pharmacokinetic variability of Certolizumab Pegol in patients with crohn s disease
    Clinical Pharmacokinectics, 2017
    Co-Authors: William J Sandborn, Brian G Feagan, Jason Coarse, Niels Vande Casteele, Diane R Mould, Iram Hasan, Ann Gils
    Abstract:

    Certolizumab Pegol is an effective biologic for patients with Crohn’s disease (CD). Individual differences in Certolizumab Pegol apparent clearance (CL/F) affect exposure and possibly efficacy. A previously developed population pharmacokinetic (PK) model did not account for dynamic changes in clinical parameters during therapy. The aim of this study was to refine the existing PK model to capture the time-varying influence of covariates. Data collected from 2157 Crohn’s disease patients in nine studies were analyzed using nonlinear mixed-effects modeling software (NONMEM). Certolizumab Pegol concentration–time data were described by a one-compartment PK model with first-order absorption, and one-compartment disposition with linear, time-dependent elimination using antidrug antibody (ADAb) concentration as a continuous variable. The final dataset consisted of 12,926 analyzable records. Parameter estimates were absorption rate constant 1.83/day, CL/F 0.527 L/day, and apparent volume of distribution (V/F) 8.33 L. ADAb concentration (2.5–214 units/mL) increased the median CL/F by 142–174%. For a typical patient, body weight (46.8–100.5 kg) increased the median CL/F and V/F from 82 to 120%. Albumin (32–48 g/L) decreased and C-reactive protein (0.5–54.0 mg/L) increased the median CL/F from 123 to 85% and from 83 to 113%, respectively. Between-patient variability of CL/F was 19.6%. By incorporating time-varying covariates, this population PK model reduces between-patient variability on CL/F estimates, and the relative influence of ADAb can now be assessed. As Crohn’s disease patient covariates are often time-dependent, this model is more reflective of patient drug exposure with sustained treatment.

  • early remission status predicts long term outcomes in patients with crohn s disease treated with Certolizumab Pegol
    Current Medical Research and Opinion, 2016
    Co-Authors: Gil Y Melmed, Stefan Schreiber, Jason Coarse, Marshall Spearman, Gordana Kosutic, Dermot P B Mcgovern, William J Sandborn
    Abstract:

    AbstractBackground: In Crohn’s disease (CD), rapid response to anti–tumor necrosis factor therapy improves short- and medium-term outcomes, but the relationship between early remission (ER) and long-term remission is unclear.Aims: This exploratory analysis of PRECiSE 3 (NCT00160524) assessed whether ER after initiation of Certolizumab Pegol predicted long-term remission.Methods: Patients enrolled in PRECiSE 3 had completed PRECiSE 1 or 2, two randomized placebo-controlled studies for moderate to severe CD, and received open-label Certolizumab Pegol 400 mg every 4 weeks for a total treatment duration of ≤7.5 years. Time to loss of remission between patients with and without ER (Harvey–Bradshaw Index ≤4 at or before Week 6 of PRECiSE 1 or 2) was compared by log-rank test of Kaplan–Meier estimates.Results: At baseline, patients with (n = 242) and without (n = 148) ER had mean (standard deviation [SD]) durations of CD of 6.8 (6.6) and 7.4 (7.8) years, mean (SD) CD Activity Index scores of 280.3 (53.4) and 311...

Philip J Mease - One of the best experts on this subject based on the ideXlab platform.

  • sustained efficacy safety and patient reported outcomes of Certolizumab Pegol in axial spondyloarthritis 4 year outcomes from rapid axspa
    Rheumatology, 2017
    Co-Authors: Desiree Van Der Heijde, R Landewe, M Dougados, Joachim Sieper, Walter P Maksymowych, Martin Rudwaleit, Filip Van Den Bosch, Jurgen Braun, Philip J Mease, Alan Kivitz
    Abstract:

    Objective The aim was to assess the long-term safety and efficacy of Certolizumab Pegol over 4 years of continuous treatment in patients with axial spondyloarthritis (axSpA), including both AS and non-radiographic (nr-) axSpA.

  • sustained efficacy safety and patient reported outcomes of Certolizumab Pegol in axial spondyloarthritis 4 year outcomes from rapid axspa
    Rheumatology, 2017
    Co-Authors: Desiree Van Der Heijde, R Landewe, M Dougados, Joachim Sieper, Walter P Maksymowych, Martin Rudwaleit, Filip Van Den Bosch, Jurgen Braun, Philip J Mease, Alan Kivitz
    Abstract:

    Objective The aim was to assess the long-term safety and efficacy of Certolizumab Pegol over 4 years of continuous treatment in patients with axial spondyloarthritis (axSpA), including both AS and non-radiographic (nr-) axSpA. Methods RAPID-axSpA was a phase 3 randomized trial, double blind and placebo controlled to week 24, dose blind to week 48 and open label to week 204. Patients had a clinical diagnosis of axSpA, meeting Assessment of SpondyloArthritis international Society (ASAS) criteria, and had active disease. The assessed outcomes included ASAS20, ASAS40, AS DAS (ASDAS), BASDAI, BASFI and BASMI scores, along with selected measures of remission. Further patient-reported outcomes, peripheral arthritis, enthesitis, uveitis and quality-of-life measures are also reported. Results Two hundred and eighteen of 325 patients randomized (AS: 121; nr-axSpA: 97) received Certolizumab Pegol from week 0. Of these, 65% remained in the study at week 204 (AS: 67%; nr-axSpA: 63%). Across all outcomes, for AS and nr-axSpA, sustained improvements were observed to week 204 [week 204 overall axSpA: ASAS20: 54.1% (non-responder imputation); 83.7% (observed case, OC); ASAS40: 44.0% (non-responder imputation); 68.1% (OC); ASDAS inactive disease: 32.1% (last observation carried forward); 31.4% (OC)]. In the safety set (n = 315), there were 292.8 adverse events and 10.4 serious adverse events per 100 patient-years. No deaths were reported. Conclusion In the first study to evaluate the efficacy of an anti-TNF across both axSpA subpopulations, improvements in clinical and patient-reported outcomes at 24 and 96 weeks were sustained through 4 years of treatment, with no new safety signals. Trial registration ClinicalTrials.gov, http://clinicaltrials.gov, NCT01087762.

  • effect of Certolizumab Pegol over 96 weeks in patients with psoriatic arthritis with and without prior antitumour necrosis factor exposure
    RMD Open, 2015
    Co-Authors: Philip J Mease, Roy Fleischmann, J Wollenhaupt, Dafna D Gladman, Majed Khraishi, A Deodhar, P Leszczynski, P Vitek, Anthony Turkiewicz, Oliver Fitzgerald
    Abstract:

    Objective Previous reports of RAPID-PsA (NCT01087788) demonstrated efficacy and safety of Certolizumab Pegol (CZP) over 24 weeks in patients with psoriatic arthritis (PsA), including patients with prior antitumour necrosis factor (TNF) therapy. We report efficacy and safety data from a 96-week data cut of RAPID-PsA. Methods RAPID-PsA was placebo-controlled to week 24, dose-blind to week 48 and open-label to week 216. We present efficacy data including American College of Rheumatology (ACR)/Psoriasis Area and Severity Index (PASI) responses, HAQ-DI, pain, minimal disease activity (MDA), modified total Sharp score (mTSS) and ACR responses in patients with/without prior anti-TNF exposure, in addition to safety data. Results Of 409 patients randomised, 273 received CZP from week 0. 54 (19.8%) CZP patients had prior anti-TNF exposure. Of patients randomised to CZP, 91% completed week 24, 87% week 48 and 80% week 96. ACR responses were maintained to week 96: 60% of patients achieved ACR20 at week 24, and 64% at week 96. Improvements were observed with both CZP dose regimens. ACR20 responses were similar in patients with (week 24: 59%; week 96: 63%) and without (week 24: 60%; week 96: 64%) prior anti-TNF exposure. Placebo patients switching to CZP displayed rapid clinical improvements, maintained to week 96. In patients with ≥3% baseline skin involvement (60.8% week 0 CZP patients), PASI responses were maintained to week 96. No progression of structural damage was observed over the 96-week period. In the Safety Set (n=393), adverse events occurred in 345 patients (87.8%) and serious adverse events in 67 (17.0%), including 6 fatal events. Conclusions CZP efficacy was maintained to week 96 with both dose regimens and in patients with/without prior anti-TNF exposure. The safety profile was in line with that previously reported from RAPID-PsA, with no new safety signals observed with increased exposure. Trial registration number NCT01087788.

  • effect of Certolizumab Pegol over ninety six weeks in patients with axial spondyloarthritis results from a phase iii randomized trial
    Arthritis & Rheumatism, 2015
    Co-Authors: Joachim Sieper, R Landewe, Desiree Van Der Heijde, M Dougados, Martin Rudwaleit, Jurgen Braun, Philip J Mease, Alan Kivitz, A Deodhar, Jessica A Walsh
    Abstract:

    Objective Previous reports of the RAPID-axSpA trial ({"type":"clinical-trial","attrs":{"text":"NCT01087762","term_id":"NCT01087762"}}NCT01087762) described the efficacy and safety of Certolizumab Pegol (CZP) over 24 weeks in patients with axial spondyloarthritis (SpA), including ankylosing spondylitis (AS) and nonradiographic axial SpA. We report efficacy and safety data up to week 96 of the study.

  • improvements in productivity at paid work and within the household and increased participation in daily activities after 24 weeks of Certolizumab Pegol treatment of patients with psoriatic arthritis results of a phase 3 double blind randomised placeb
    Annals of the Rheumatic Diseases, 2015
    Co-Authors: Arthur Kavanaugh, O Purcaru, Dafna D Gladman, D Van Der Heijde, Philip J Mease
    Abstract:

    Objectives To evaluate the effect of Certolizumab Pegol (CZP) on productivity outside and within the home, and on participation in family, social and leisure activities in adult patients with psoriatic arthritis (PsA). Methods RAPID-PsA (NCT01087788) is a phase 3, double-blind, placebo-controlled trial. 409 patients with active PsA were randomised 1:1:1 to placebo, CZP 200 mg every 2 weeks (Q2W) or CZP 400 mg every 4 weeks (Q4W). The arthritis-specific Work Productivity Survey (WPS) assessed the impact of PsA on paid work and household productivity, and participation in social activities during the preceding month. WPS responses were compared between treatment arms using a non-parametric bootstrap-t method. Results At baseline, 56.6%, 60.1% and 61.5% of placebo, CZP 200 mg Q2W and CZP 400 mg Q4W patients were employed. By week 24, employed CZP patients reported an average of 1.0–1.8 and 3.0–3.9 fewer days of absenteeism and presenteeism, respectively, per month compared with 1.0 and 0.3 fewer days for placebo patients (p Conclusions CZP treatment significantly improved productivity at paid work and within the home, and resulted in greater participation in social activities for PsA patients. Trial registration number NCT01087788.

Stefan Schreiber - One of the best experts on this subject based on the ideXlab platform.

  • effects of transient and persistent anti drug antibodies to Certolizumab Pegol longitudinal data from a 7 year study in crohn s disease
    Inflammatory Bowel Diseases, 2017
    Co-Authors: William J Sandborn, Razvan Arsenescu, Stefan Schreiber, Douglas C Wolf, Gordana Kosutic, Anita Afzali, Bincy Abraham, Scott D Lee, Gerry Parker, Alexandra Gutierrez
    Abstract:

    BACKGROUND Anti-drug antibodies (ADAbs) may decrease the efficacy of biologics and increase the risk of adverse events. A single positive test may not preclude further treatment because of variations in assays used, test timing, and patient variables. We evaluated the longitudinal patterns of immunogenicity during 7 years of antitumor necrosis factor-alpha drug Certolizumab Pegol (CZP) treatment for moderate-to-severe Crohn's disease. METHODS PRECiSE 3 patients (n = 595) received open-label CZP 400 mg every 4 weeks up to 7 years. CZP-ADAb expression, plasma CZP concentration, Harvey-Bradshaw Index, C-reactive protein, and fecal calprotectin concentrations were measured multiple times. Longitudinal data, examined for CZP-ADAb positivity and categorized as transient (with temporary/no effect on CZP concentration), persistent, or negative, were correlated with clinical and biological variables. RESULTS Of the CZP-ADAb-positive patients, 40 (22.6%) had transient CZP-ADAbs and 94 (77.4%) had persistent CZP-ADAbs. Demographic characteristics were similar between groups. Median C-reactive protein and fecal calprotectin were higher (P < 0.05 at some visits) and plasma CZP concentrations were significantly lower (P < 0.0001 at all visits) in the persistent CZP-ADAb-positive group relative to the CZP-ADAb-negative group. Transient CZP-ADAb-positive and CZP-ADAb-negative patients had similar plasma CZP, C-reactive protein, and fecal calprotectin concentrations. Median Harvey-Bradshaw Index scores and rates of adverse events were similar among groups. CONCLUSIONS This analysis demonstrates that persistent CZP-ADAb has negative effects on drug levels and efficacy, whereas transient expression may not. Serial measurements may be needed to characterize ADAb positivity. www.clinicaltrials.gov, Number NCT00160524.

  • safety of long term treatment with Certolizumab Pegol in patients with crohn s disease based on a pooled analysis of data from clinical trials
    Clinical Gastroenterology and Hepatology, 2016
    Co-Authors: Edward V Loftus, Charles Randall, Stefan Schreiber, Jeanfrederic Colombel, Miguel Regueiro, Tauseef Ali, C Arendt, Jason Coarse, Marshall Spearman, Gordana Kosutic
    Abstract:

    BACKGROUND & AIMS Treatments for Crohn's disease (CD) have been linked to serious infections, malignancies, and dermatologic complications. We pooled and analyzed clinical trials of Certolizumab Pegol, a pegylated humanized Fab' fragment against tumor necrosis factor, to quantify safety events in patients with CD. METHODS We collected data from 5 placebo-controlled trials, 9 open-label studies, and 1 dose-regimen study, conducted globally through April 2014. A total of 2570 patients with moderate to severe CD were treated with Certolizumab Pegol, with 4378.1 patient-years of exposure. Data were analyzed in 2 groups: patients from placebo-controlled (PC) trials treated with placebo (n = 875) or Certolizumab Pegol (n = 919) for 6 to 38 weeks (the PC group) or all patients exposed to Certolizumab Pegol (n = 2570), for durations of 6 to 362 weeks (the all-studies group). Incidence rates (IRs; incidence/100 patient-years) of adverse events (AEs) were calculated from first dose through 70 days (approximately 5 half-lives) after the last dose. RESULTS In the PC group, IRs for serious AEs were similar among patients given Certolizumab Pegol (31.35/100 patient-years) vs placebo (24.33/100 patient-years). IRs of serious infections or malignancies were low among patients receiving short-term treatment with Certolizumab Pegol (8.49/100 patient-years and 1.01/100 patient-years, respectively, in the PC group) and did not increase with long-term treatment (6.47/100 patient-years and 0.80/100 patient-years, respectively, in the all-studies group). IRs of psoriasis or psoriasiform dermatitis were low in the PC group (1.01/100 patient-years and 0/100 patient-years, respectively); in the placebo group, these IRs were 0.38 per 100 patient-years and 0 per 100 patient-years, respectively. IRs of psoriasis or psoriasiform dermatitis did not increase with long-term treatment (0.93/100 patient-years and 0.09/100 patient-years, respectively, in the all-studies group). CONCLUSIONS Based on an analysis of data pooled from 15 trials of patients with CD, the safety profile for long-term therapy with Certolizumab Pegol therapy is similar to that reported from short-term studies. Overall rates of AEs, serious infections, malignancies, and psoriasis did not increase with long-term treatment, suggesting a favorable risk-benefit ratio with long-term Certolizumab Pegol therapy in CD. Clinicaltrials.gov identifiers: NCT00291668, NCT00152490, NCT00152425, NCT00308581, NCT00349752, NCT00552058, NCT00329550, NCT00329420, NCT00160524, NCT00160706, NCT00297648, NCT00333788, NCT00307931, NCT00356408, and NCT00552344 (https://www.clinicaltrials.gov/ct2/search).

  • early remission status predicts long term outcomes in patients with crohn s disease treated with Certolizumab Pegol
    Current Medical Research and Opinion, 2016
    Co-Authors: Gil Y Melmed, Stefan Schreiber, Jason Coarse, Marshall Spearman, Gordana Kosutic, Dermot P B Mcgovern, William J Sandborn
    Abstract:

    AbstractBackground: In Crohn’s disease (CD), rapid response to anti–tumor necrosis factor therapy improves short- and medium-term outcomes, but the relationship between early remission (ER) and long-term remission is unclear.Aims: This exploratory analysis of PRECiSE 3 (NCT00160524) assessed whether ER after initiation of Certolizumab Pegol predicted long-term remission.Methods: Patients enrolled in PRECiSE 3 had completed PRECiSE 1 or 2, two randomized placebo-controlled studies for moderate to severe CD, and received open-label Certolizumab Pegol 400 mg every 4 weeks for a total treatment duration of ≤7.5 years. Time to loss of remission between patients with and without ER (Harvey–Bradshaw Index ≤4 at or before Week 6 of PRECiSE 1 or 2) was compared by log-rank test of Kaplan–Meier estimates.Results: At baseline, patients with (n = 242) and without (n = 148) ER had mean (standard deviation [SD]) durations of CD of 6.8 (6.6) and 7.4 (7.8) years, mean (SD) CD Activity Index scores of 280.3 (53.4) and 311...

  • reinduction with Certolizumab Pegol in patients with crohn s disease experiencing disease exacerbation 7 year data from the precise 4 study
    Inflammatory Bowel Diseases, 2016
    Co-Authors: David T. Rubin, Charles Randall, Robert Burakoff, David G Binion, Themos Dassopoulos, William J Sandborn, David A Schwartz, Ziad Younes, Stefan Schreiber, Razvan Arsenescu
    Abstract:

    Crohn's disease is a lifelong, incurable inflammatory disease of the gastrointestinal tract that often arises in the earlier decades of life and is characterized by periods of exacerbation and remission. Tumor necrosis factor (TNF) α has a central role in the pathogenesis of inflammatory bowel diseases, and specific inhibition of this pleotropic cytokine with biological anti-TNF agents has been a major advancement in the treatment of these diseases including Crohn's disease.1,2 Anti-TNF therapy is generally well tolerated.3–5 However, because these agents have immunosuppressive properties, long-term use may increase the risk of serious infections,6 and careful consideration is given to the initiation of therapy. Only 3 anti-TNF therapies, including infliximab, adalimumab, and Certolizumab Pegol, are currently approved for the treatment of moderate to severe Crohn's disease in the United States. In randomized controlled trials, approximately 40% to 60% of patients with Crohn's disease had an initial response to induction therapy with anti-TNF therapy during the first 2 to 6 weeks, and of those approximately 40% to 60% were in remission after 6 months of therapy.3–5,7 However, the duration of clinical response varies widely among patients. Results of PRECiSE 2, a randomized, placebo-controlled study of Certolizumab Pegol maintenance therapy in patients with moderate to severe Crohn's disease, showed that approximately 40% of initial responders lost response within 6 months after treatment initiation.5 In clinical practice, 30% to 40% of patients treated with adalimumab required dose escalation; however, approximately one-third of those who received increased doses failed to maintain responses longer than 6 months.8 These examples illustrate that both primary and secondary failure to anti-TNF therapy remain significant challenges in the treatment of patients with Crohn's disease. Given the need for long-term maintenance therapy and the small number of available anti-TNF therapies, identifying strategies to maximize the benefit that a patient can derive from each agent is important. Recent studies have shown that reinduction therapy with another9 or the same10 anti-TNF agent in patients with secondary treatment failure provides clinically important short-term benefits. However, the longer-term benefit of reintroducing the same therapy to patients with primary and secondary treatment failure, including patients who previously received as little as 1 dose of induction treatment, has not been explored. Certolizumab Pegol is a recombinant, humanized, polyethylene glycol–conjugated antigen-binding antibody fragment (Fab') with specificity for human TNFα. Two randomized, double-blind, placebo-controlled phase 3 studies, PRECiSE 17 and PRECiSE 2,5 demonstrated that Certolizumab Pegol is effective in the induction and maintenance of clinical response and remission in patients with moderate to severe Crohn's disease. Unlike patients in PRECiSE 2, who were randomized to maintenance treatment with placebo or Certolizumab Pegol after responding to 6 weeks of induction therapy with Certolizumab Pegol, patients in PRECiSE 1 were randomized to consecutive induction and maintenance treatment with either placebo or Certolizumab Pegol at the start of the trial. Patients who completed PRECiSE 1 or PRECiSE 2 were eligible for inclusion in PRECiSE 3, an open-label, 7-year extension study.11 In contrast, PRECiSE 4 (NCT00160706) was an open-label extension study for patients who withdrew from either treatment arm of PRECiSE 1 or PRECiSE 2 owing to exacerbation of Crohn's disease and was designed to assess the safety and efficacy of chronic Certolizumab Pegol therapy for up to 7 years. Here, we report efficacy and safety outcomes from the PRECiSE 4 study, which included patients with no previous exposure to Certolizumab Pegol, as well as patients with primary or secondary Certolizumab Pegol treatment failure.

  • long term safety and efficacy of Certolizumab Pegol in the treatment of crohn s disease 7 year results from the precise 3 study
    Alimentary Pharmacology & Therapeutics, 2014
    Co-Authors: W J Sandborn, Charles Randall, David A Schwartz, Stefan Schreiber, Alexandra Gutierrez, Scott D Lee, Bosny Pierrelouis, Sumeet Ambarkhane, C Kayhan, Gary R Lichtenstein
    Abstract:

    BackgroundThe efficacy and safety of Certolizumab Pegol (CZP) in moderate-to-severe Crohn's disease were demonstrated in two 26-week double-blind studies (PRECiSE 1 & 2). AimTo report the safety and efficacy outcomes of long-term, CZP therapy from PRECiSE 3, in which patients received treatment up to 7years treatment. MethodsPatients completing PRECiSE 1 or 2 were eligible to enter PRECiSE 3 in which they received CZP 400mg, open-label, every 4weeks (without additional induction therapy) for up to 7years, for up to 91 doses from study start. Safety (adverse events, including infections and malignancies) and efficacy (Harvey-Bradshaw Index, faecal calprotectin, C-reactive protein) were prospectively monitored. Remission was analysed using observed cases, last observation carried forward imputation and nonresponder imputation. ResultsA total of 595 patients entered the study; 117 (20%) completed 7years. Discontinuation rates were 29.2%, 13.6%, 16.1%, 7.9%, 5.0%, 4.5% and 3.9% (years 1-7 respectively). During 1920 patient-years of exposure to CZP, no new safety signals were observed. Incidence rates (new cases/100 patient-years) for serious infections and malignant neoplasms were 4.37 and 1.06 respectively. No lymphoproliferative malignancies were reported. Clinical remission rates were 68% at each year (observed cases); rates by last observation carried forward and nonresponder imputation were 58% and 45% at year 1, 56% and 26% at year 3 and 55% and 13% at year 7 respectively. ConclusionCertolizumab Pegol was well tolerated in the long-term treatment of Crohn's disease, with sustained remission in some patients continuing in the study for up to 7years. ClinicalTrials.gov identifier NCT00552058.

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  • induction of sustained clinical remission in early axial spondyloarthritis following Certolizumab Pegol treatment 48 week outcomes from c optimise
    Rheumatology and Therapy, 2020
    Co-Authors: R Landewe, Desiree Van Der Heijde, M Dougados, Filip Van Den Bosch, Xenofon Baraliakos, Karl Gaffney, Lars Bauer, B Hoepken, Natasha De Peyrecave
    Abstract:

    Achievement of remission is a key treatment goal for patients with axial spondyloarthritis (axSpA). C-OPTIMISE assessed achievement of sustained clinical remission in patients with axSpA, including radiographic (r) and non-radiographic (nr) axSpA, during Certolizumab Pegol (CZP) treatment, and subsequent maintenance of remission following CZP dose continuation, dose reduction or withdrawal. Here, we report outcomes from the first 48 weeks (induction period) of C-OPTIMISE, during which patients received open-label CZP. C-OPTIMISE (NCT02505542) was a two-part, multicenter, phase 3b study in adult patients with early axSpA (r-/nr-axSpA), including a 48-week open-label induction period followed by a 48-week maintenance period. Patients with active adult-onset axSpA, < 5 years’ symptom duration, and fulfilling Assessment of SpondyloArthritis international Society classification criteria, were included. During the induction period, patients received a loading dose of CZP 400 mg at weeks 0, 2, and 4, followed by CZP 200 mg every 2 weeks (Q2W) up to week 48. The main outcome of the 48-week induction period was the achievement of sustained clinical remission (defined as an Ankylosing Spondylitis Disease Activity Score [ASDAS] < 1.3 at week 32 and < 2.1 at week 36 [or vice versa], and < 1.3 at week 48). In total, 736 patients (407 with r-axSpA, 329 with nr-axSpA) were enrolled into the study. At week 48, 43.9% (323/736) of patients achieved sustained remission, including 42.8% (174/407) of patients with r-axSpA and 45.3% (149/329) with nr-axSpA. Patients also demonstrated substantial improvements in axSpA symptoms, MRI outcomes and quality of life measures. Adverse events occurred in 67.9% (500/736) of patients, of which 6.0% (44/736) were serious. Over 40% of patients with early axSpA achieved sustained remission during 48 weeks of open-label CZP treatment. Additionally, patients across the axSpA spectrum demonstrated substantial improvements in imaging outcomes and quality of life following treatment. No new safety signals were identified. NCT02505542.

  • maintenance of clinical remission in early axial spondyloarthritis following Certolizumab Pegol dose reduction
    Annals of the Rheumatic Diseases, 2020
    Co-Authors: R Landewe, Desiree Van Der Heijde, O Davies, M Dougados, Filip Van Den Bosch, Xenofon Baraliakos, Karl Gaffney, Lars Bauer, B Hoepken, Natasha De Peyrecave
    Abstract:

    Background The best strategy for maintaining clinical remission in patients with axial spondyloarthritis (axSpA) has not been defined. C-OPTIMISE compared dose continuation, reduction and withdrawal of the tumour necrosis factor inhibitor Certolizumab Pegol (CZP) following achievement of sustained remission in patients with early axSpA. Methods C-OPTIMISE was a two-part, multicentre phase 3b study in adults with early active axSpA (radiographic or non-radiographic). During the 48-week open-label induction period, patients received CZP 200 mg every 2 weeks (Q2W). At Week 48, patients in sustained remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) 3.5 at any time point) during the double-blind period. Results At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo. During Weeks 48 to 96, 83.7% (87/104), 79.0% (83/105) and 20.2% (21/104) of patients receiving the full maintenance dose, reduced maintenance dose or placebo, respectively, were flare-free (p Conclusions Patients with early axSpA who achieve sustained remission at 48 weeks can reduce their CZP maintenance dose; however, treatment should not be completely discontinued due to the high risk of flare following CZP withdrawal. Trial registration number NCT02505542, ClinicalTrials.gov.

  • a fifty two week randomized placebo controlled trial of Certolizumab Pegol in nonradiographic axial spondyloarthritis
    Arthritis & Rheumatism, 2019
    Co-Authors: A Deodhar, R Landewe, Stephen Hall, Walter P Maksymowych, Martin Rudwaleit, Lars Bauer, Lianne S Gensler, Jonathan Kay, Nigil Haroon, B Hoepken
    Abstract:

    Author(s): Deodhar, Atul; Gensler, Lianne S; Kay, Jonathan; Maksymowych, Walter P; Haroon, Nigil; Landewe, Robert; Rudwaleit, Martin; Hall, Stephen; Bauer, Lars; Hoepken, Bengt; de Peyrecave, Natasha; Kilgallen, Brian; van der Heijde, Desiree | Abstract: ObjectiveThe natural history of nonradiographic axial spondyloarthritis (SpA) is incompletely characterized, and there are concerns that nonsteroidal antiinflammatory drugs provide inadequate disease control in patients with active disease. This study was undertaken to investigate the effects of Certolizumab Pegol (CZP), an anti-tumor necrosis factor treatment, in patients with nonradiographic axial SpA with objective signs of inflammation.MethodsIn this ongoing parallel-group double-blind study, adults with active disease were recruited from 80 centers in Australia, Europe, North America, and Taiwan, and were randomized 1:1 to receive placebo or CZP (400 mg at weeks 0, 2, and 4, followed by 200 mg every 2 weeks) in addition to nonbiologic background medication (NBBM). Switching to open-label CZP (or other biologic) or making background medication changes was permitted at any point during the trial, although changes before week 12 were discouraged. The primary end point was the proportion of patients achieving major improvement (MI) (i.e., a ≥2.0-point decrease in the score from baseline or achievement of the lowest possible score [0.6]) in the Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 52.ResultsA total of 317 patients were randomized to receive placebo plus NBBM (n = 158) or CZP plus NBBM (n = 159). ASDAS-MI at week 52 was achieved in 47.2% (75 of 159) of CZP plus NBBM patients, which was significantly greater (P l 0.0001) than the 7.0% (11 of 158) of placebo plus NBBM patients in whom ASDAS-MI was achieved. Of the placebo plus NBBM patients, 60.8% (96 of 158) switched to open-label treatment before week 52 compared to 12.6% (20 of 159) of the CZP plus NBBM patients.ConclusionAdding CZP to background medication is superior to adding placebo in patients with active nonradiographic axial SpA. These results indicate that remission in nonradiographic axial SpA treated without biologics occurs infrequently, demonstrating the need for treatment beyond nonbiologic therapy.

  • efficacy and safety of bimekizumab as add on therapy for rheumatoid arthritis in patients with inadequate response to Certolizumab Pegol a proof of concept study
    Annals of the Rheumatic Diseases, 2019
    Co-Authors: Sophie Glatt, R Landewe, Lucian Ionescu, Peter C Taylor, Iain B Mcinnes, Georg Schett, Dominique Baeten, Foteini Strimenopoulou, Mark I L Watling, Stevan Shaw
    Abstract:

    Objective Evaluate the efficacy and safety of dual neutralisation of interleukin (IL)-17A and IL-17F with bimekizumab, a monoclonal IgG1 antibody, in addition to Certolizumab Pegol (CZP) in patients with rheumatoid arthritis (RA) and inadequate response (IR) to Certolizumab Pegol. Methods During this phase 2a, double-blind, proof-of-concept (PoC) study (NCT02430909), patients with moderate-to-severe RA received open-label CZP 400 mg at Weeks 0, 2 and 4, and 200 mg at Week 6. Patients with IR at Week 8 (Disease Activity Score 28-joint count C-reactive protein (DAS28(CRP))>3.2) were randomised 2:1 to CZP (200 mg every 2 weeks (Q2W)) plus bimekizumab (240 mg loading dose then 120 mg Q2W) or CZP plus placebo. The primary efficacy and safety variables were change in DAS28(CRP) between Weeks 8 and 20 and incidence of treatment-emergent adverse events (TEAEs). Results Of 159 patients enrolled, 79 had IR at Week 8 and were randomised to CZP plus bimekizumab (n=52) or CZP plus placebo (n=27). At Week 20, there was a greater reduction in DAS28(CRP) in the CZP-IR plus bimekizumab group compared with the CZP-IR plus placebo group (99.4% posterior probability). The most frequent TEAEs were infections and infestations (CZP plus bimekizumab, 50.0% (26/52); CZP plus placebo, 22.2% (6/27)). Conclusions PoC was confirmed based on the rapid decrease in disease activity achieved with 12 weeks of CZP plus bimekizumab. No unexpected or new safety signals were identified when neutralising IL-17A and IL-17F in patients with RA concomitantly treated with CZP, but the rate of TEAEs was higher with dual inhibition.

  • fri0408 earlier treatment of non radiographic axial spondyloarthritis with Certolizumab Pegol results in improved clinical outcomes
    Annals of the Rheumatic Diseases, 2019
    Co-Authors: Martin Rudwaleit, R Landewe, Walter P Maksymowych, A Deodhar, Natasha De Peyrecave, Lianne S Gensler, Jonathan Kay, Nigil Haroon, Simone E Auteri, Thomas Kumke
    Abstract:

    Background Patients (pts) with axial spondyloarthritis (axSpA) often experience delayed diagnosis, which leads to treatment delay.1Whilst Certolizumab Pegol (CZP) has been shown to improve the signs and symptoms of non-radiographic (nr)-axSpA,2 whether earlier CZP treatment is beneficial in these pts is unclear. Objectives To report clinical outcomes in pts with nr–axSpA treated with CZP or placebo (PBO) over 52 weeks (wks) by their symptom duration. Methods Post-hoc analyses of disease outcomes in pts stratified by symptom duration ( Results Of 317 recruited pts, 159 were randomised to CZP, and 158 to PBO. The mean (standard deviation [SD]) BL symptom duration was 7.8 (7.7) yrs for CZP-treated pts and 8.0 (7.5) yrs for PBO pts. 50.3% (80/159) CZP pts and 48.7% (77/158) PBO pts had a symptom duration Conclusion In this post-hoc analysis, CZP-treated nr-axSpA pts with shorter symptom duration ( References [1] Rudwaleit M. Arthritis Rheum 2009;60:717–27; 2. Deodhar A. Arthritis Rheumatol 2018;70(S9):2073–4. Acknowledgement We thank the patients who participated. This study was funded by UCB Pharma, medical writing by Jessica Patel, Costello Medical, UK.sts: Disclosure of Intere: Martin Rudwaleit Consultant for: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Consultant for: AbbVie, BMS, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB Pharma, Lianne S. Gensler Grant/research support from: Abbvie, Amgen, UCB Pharma, Consultant for: Novartis, Lilly, Janssen, Atul Deodhar Grant/research support from: AbbVie, Amgen, Eli Lilly, GSK, Janssen, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Amgen, BMS, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Jonathan Kay Grant/research support from: Gilead Sciences, Pfizer, UCB Pharma, Consultant for: AbbVie, Boehringer Ingelheim GmbH, Celltrion Healthcare, Merck Sharp & Dohme Corp., Novartis Pharmaceuticals, Pfizer, Samsung Bioepis, Sandoz, UCB Pharma, Walter P Maksymowych Grant/research support from: AbbVie, Pfizer, Janssen, Novartis, Consultant for: AbbVie, Eli Lilly, Boehringer, Galapagos, Janssen, Novartis, Pfizer and UCB Pharma; Chief Medical Officer for Canadian Research and Education Arthritis, Nigil Haroon Consultant for: AbbVie, Amgen, Janssen, Merck, Novartis, UCB Pharma, Robert B.M. Landewe: None declared, Simone Auteri Employee of: Employee of UCB Pharma, Natasha de Peyrecave Employee of: Employee of UCB Pharma, Thomas Kumke Employee of: UCB Pharma, Desiree van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, Union Chimique Belge

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