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Raj Tummala – One of the best experts on this subject based on the ideXlab platform.

  • long term safety and efficacy of Anifrolumab in adults with systemic lupus erythematosus results of a phase 2 open label extension study
    Arthritis & Rheumatism, 2020
    Co-Authors: W. Winn Chatham, Richard Furie, Philip Brohawn, Erik Schwetje, Gabriel Abreu, Amit Saxena, Raj Tummala

    Abstract:

    OBJECTIVE To investigate long-term safety and tolerability of Anifrolumab, a human monoclonal antibody to the type I interferon (IFN) receptor subunit 1, in patients with moderate to severe systemic lupus erythematosus (SLE). METHODS This 3-year, multinational, open-label extension (OLE) enrolled adult patients who completed treatment (48 weeks Anifrolumab or placebo; 12-week follow-up) in the MUSE phase 2b randomized controlled trial (RCT). Patients initially received intravenous Anifrolumab 1000 mg every 4 weeks, reduced to 300 mg every 4 weeks based on the benefit/risk profile established in MUSE. Adverse events (AEs) were assessed monthly. Exploratory endpoints included SLE Disease Activity Index 2000 (SLEDAI-2K), SLICC Damage Index (SDI), pharmacodynamics, and health-related quality of life (HRQoL). RESULTS Of 246 patients who completed the RCT, 218 (88.6%) enrolled in the OLE; 139/218 (63.8%) completed 3 years of treatment. Approximately 69.7% of patients reported ≥1 AE during the first year of OLE treatment. Frequency and patterns of serious AEs and AEs of special interest over 3 years were consistent with those reported for 1 year of treatment in the RCT. Few patients (6.9%) discontinued treatment because of AEs. No new safety signals were identified. Improvement in SLEDAI-2K was sustained over 3 years. SDI and Short Form 36 Health Survey scores remained stable. Neutralization of type I IFN gene signatures was maintained in the IFN-high population, and C3, C4, and anti-dsDNA showed numeric trends toward sustained improvement. CONCLUSION Long-term Anifrolumab treatment demonstrated an acceptable safety profile with sustained improvement in disease activity, HRQoL, and serologies.

  • Long‐term safety and efficacy of Anifrolumab in adults with systemic lupus erythematosus: results of a phase 2 open‐label extension study
    Arthritis & rheumatology (Hoboken N.J.), 2020
    Co-Authors: W. Winn Chatham, Richard Furie, Philip Brohawn, Erik Schwetje, Gabriel Abreu, Amit Saxena, Raj Tummala

    Abstract:

    OBJECTIVE To investigate long-term safety and tolerability of Anifrolumab, a human monoclonal antibody to the type I interferon (IFN) receptor subunit 1, in patients with moderate to severe systemic lupus erythematosus (SLE). METHODS This 3-year, multinational, open-label extension (OLE) enrolled adult patients who completed treatment (48 weeks Anifrolumab or placebo; 12-week follow-up) in the MUSE phase 2b randomized controlled trial (RCT). Patients initially received intravenous Anifrolumab 1000 mg every 4 weeks, reduced to 300 mg every 4 weeks based on the benefit/risk profile established in MUSE. Adverse events (AEs) were assessed monthly. Exploratory endpoints included SLE Disease Activity Index 2000 (SLEDAI-2K), SLICC Damage Index (SDI), pharmacodynamics, and health-related quality of life (HRQoL). RESULTS Of 246 patients who completed the RCT, 218 (88.6%) enrolled in the OLE; 139/218 (63.8%) completed 3 years of treatment. Approximately 69.7% of patients reported ≥1 AE during the first year of OLE treatment. Frequency and patterns of serious AEs and AEs of special interest over 3 years were consistent with those reported for 1 year of treatment in the RCT. Few patients (6.9%) discontinued treatment because of AEs. No new safety signals were identified. Improvement in SLEDAI-2K was sustained over 3 years. SDI and Short Form 36 Health Survey scores remained stable. Neutralization of type I IFN gene signatures was maintained in the IFN-high population, and C3, C4, and anti-dsDNA showed numeric trends toward sustained improvement. CONCLUSION Long-term Anifrolumab treatment demonstrated an acceptable safety profile with sustained improvement in disease activity, HRQoL, and serologies.

  • Anifrolumab, a monoclonal antibody to the type I interferon receptor subunit 1, for the treatment of systemic lupus erythematosus: an overview from clinical trials
    Modern rheumatology, 2020
    Co-Authors: Yoshiya Tanaka, Raj Tummala

    Abstract:

    Chronic activation of the type I interferon (IFN) pathway plays a critical role in systemic lupus erythematosus (SLE) pathogenesis. Anifrolumab is a human monoclonal antibody to the type I IFN rece…

Richard Furie – One of the best experts on this subject based on the ideXlab platform.

  • long term safety and efficacy of Anifrolumab in adults with systemic lupus erythematosus results of a phase 2 open label extension study
    Arthritis & Rheumatism, 2020
    Co-Authors: W. Winn Chatham, Richard Furie, Philip Brohawn, Erik Schwetje, Gabriel Abreu, Amit Saxena, Raj Tummala

    Abstract:

    OBJECTIVE To investigate long-term safety and tolerability of Anifrolumab, a human monoclonal antibody to the type I interferon (IFN) receptor subunit 1, in patients with moderate to severe systemic lupus erythematosus (SLE). METHODS This 3-year, multinational, open-label extension (OLE) enrolled adult patients who completed treatment (48 weeks Anifrolumab or placebo; 12-week follow-up) in the MUSE phase 2b randomized controlled trial (RCT). Patients initially received intravenous Anifrolumab 1000 mg every 4 weeks, reduced to 300 mg every 4 weeks based on the benefit/risk profile established in MUSE. Adverse events (AEs) were assessed monthly. Exploratory endpoints included SLE Disease Activity Index 2000 (SLEDAI-2K), SLICC Damage Index (SDI), pharmacodynamics, and health-related quality of life (HRQoL). RESULTS Of 246 patients who completed the RCT, 218 (88.6%) enrolled in the OLE; 139/218 (63.8%) completed 3 years of treatment. Approximately 69.7% of patients reported ≥1 AE during the first year of OLE treatment. Frequency and patterns of serious AEs and AEs of special interest over 3 years were consistent with those reported for 1 year of treatment in the RCT. Few patients (6.9%) discontinued treatment because of AEs. No new safety signals were identified. Improvement in SLEDAI-2K was sustained over 3 years. SDI and Short Form 36 Health Survey scores remained stable. Neutralization of type I IFN gene signatures was maintained in the IFN-high population, and C3, C4, and anti-dsDNA showed numeric trends toward sustained improvement. CONCLUSION Long-term Anifrolumab treatment demonstrated an acceptable safety profile with sustained improvement in disease activity, HRQoL, and serologies.

  • Long‐term safety and efficacy of Anifrolumab in adults with systemic lupus erythematosus: results of a phase 2 open‐label extension study
    Arthritis & rheumatology (Hoboken N.J.), 2020
    Co-Authors: W. Winn Chatham, Richard Furie, Philip Brohawn, Erik Schwetje, Gabriel Abreu, Amit Saxena, Raj Tummala

    Abstract:

    OBJECTIVE To investigate long-term safety and tolerability of Anifrolumab, a human monoclonal antibody to the type I interferon (IFN) receptor subunit 1, in patients with moderate to severe systemic lupus erythematosus (SLE). METHODS This 3-year, multinational, open-label extension (OLE) enrolled adult patients who completed treatment (48 weeks Anifrolumab or placebo; 12-week follow-up) in the MUSE phase 2b randomized controlled trial (RCT). Patients initially received intravenous Anifrolumab 1000 mg every 4 weeks, reduced to 300 mg every 4 weeks based on the benefit/risk profile established in MUSE. Adverse events (AEs) were assessed monthly. Exploratory endpoints included SLE Disease Activity Index 2000 (SLEDAI-2K), SLICC Damage Index (SDI), pharmacodynamics, and health-related quality of life (HRQoL). RESULTS Of 246 patients who completed the RCT, 218 (88.6%) enrolled in the OLE; 139/218 (63.8%) completed 3 years of treatment. Approximately 69.7% of patients reported ≥1 AE during the first year of OLE treatment. Frequency and patterns of serious AEs and AEs of special interest over 3 years were consistent with those reported for 1 year of treatment in the RCT. Few patients (6.9%) discontinued treatment because of AEs. No new safety signals were identified. Improvement in SLEDAI-2K was sustained over 3 years. SDI and Short Form 36 Health Survey scores remained stable. Neutralization of type I IFN gene signatures was maintained in the IFN-high population, and C3, C4, and anti-dsDNA showed numeric trends toward sustained improvement. CONCLUSION Long-term Anifrolumab treatment demonstrated an acceptable safety profile with sustained improvement in disease activity, HRQoL, and serologies.

  • OP0003 EARLY AND SUSTAINED RESPONSES WITH Anifrolumab TREATMENT IN PATIENTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE) IN 2 PHASE 3 TRIALS
    Annals of the Rheumatic Diseases, 2020
    Co-Authors: Eric F. Morand, Richard Furie, Kenneth Kalunian, Ian N Bruce, Gabriel Abreu, Rubana N Kalyani, Lilia Pineda, Raj Tummala

    Abstract:

    Measuring genome size across different species can yield important insights into evolution of the genome and allow for more informed decisions when designing next-generation genomic sequencing projects. New techniques for estimating genome size using shallow genomic sequence data have emerged which have the potential to augment our knowledge of genome sizes, yet these methods have only been used in a limited number of empirical studies. In this project, we compare estimation methods using next-generation sequencing (k-mer methods and average read depth of single-copy genes) to measurements from flow cytometry, a standard method for genome size measures, using ground beetles (Carabidae) and other members of the beetle suborder Adephaga as our test system. We also present a new protocol for using read-depth of single-copy genes to estimate genome size. Additionally, we report flow cytometry measurements for five previously unmeasured carabid species, as well as 21 new draft genomes and six new draft transcriptomes across eight species of adephagan beetles. No single sequence-based method performed well on all species, and all tended to underestimate the genome sizes, although only slightly in most samples. For one species, Bembidion sp. nr. transversale, most sequence-based methods yielded estimates half the size suggested by flow cytometry.

G. Illei – One of the best experts on this subject based on the ideXlab platform.

  • Anifrolumab effects on rash and arthritis: impact of the type I interferon gene signature in the phase IIb MUSE study in patients with systemic lupus erythematosus.
    Lupus science & medicine, 2018
    Co-Authors: Joan T Merrill, Richard Furie, Munther Khamashta, Victoria P Werth, Jorn Drappa, Liangwei Wang, G. Illei, Raj Tummala

    Abstract:

    Objective This post hoc analysis compared Anifrolumab 300 mg every 4 weeks with placebo on rash and arthritis measures with different stringency in patients with moderate to severe SLE (phase IIb; MUSE; NCT01438489). Subgroups were analysed by type I interferon gene signature (IFNGS test–high or test–low). Methods Rash was measured with the SLE Disease Activity Index 2000 (SLEDAI-2K), British Isles Lupus Assessment Group (BILAG) Index and modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI). Arthritis was evaluated using SLEDAI-2K, BILAG and swollen and tender joint counts. Outcomes were measured at week 52. Results More Anifrolumab-treated patients demonstrated resolution of rash by SLEDAI-2K versus placebo: 39/88 (44.3%) versus 13/88 (14.8%), OR (90% CI) 4.56 (2.48 to 8.39), p Conclusions Anifrolumab treatment was associated with improvements versus placebo in specific SLE features of arthritis and rash using measures of different stringency. Although driven by robust data in the prevalent IFNGS test–high population, further evaluation in IFNGS test–low patients is warranted.

  • Type I interferon receptor blockade with Anifrolumab corrects innate and adaptive immune perturbations of SLE.
    Lupus science & medicine, 2018
    Co-Authors: Kerry A. Casey, Xiang Guo, L. Wang, Michael A Smith, Shiliang Wang, Dominic Sinibaldi, Miguel A. Sanjuan, G. Illei, Wendy I. White

    Abstract:

    Objective Anifrolumab is a fully human immunoglobulin G1 κ monoclonal antibody specific for subunit 1 of the type I interferon (IFN) α receptor. In a phase IIb study of adults with moderate to severe SLE, Anifrolumab treatment demonstrated substantial reductions in multiple clinical endpoints. Here, we evaluated serum proteins and immune cells associated with SLE pathogenesis, type I interferon gene signature (IFNGS) test status and disease activity, and how Anifrolumab affected these components. Methods Whole blood samples were collected from patients enrolled in MUSE (NCT01438489) for serum protein and cellular assessments at baseline and subsequent time points. Data were parsed by IFNGS test status (high/low) and disease activity. Protein expression and immune cell subsets were measured using multiplex immunoassay and flow cytometry, respectively. Blood samples from healthy donors were analysed for comparison. Results Baseline protein expression differed between patients with SLE and healthy donors, IFNGS test-high and -low patients, and patients with moderate and severe disease. Anifrolumab treatment lowered concentrations of IFN-induced chemokines associated with B, T and other immune cell migration in addition to proteins associated with endothelial activation that were dysregulated at baseline. IFNGS test-high patients and those with high disease activity were characterised by low baseline numbers of lymphocytes, circulating memory T-cell subsets and neutrophils. Anifrolumab treatment reversed lymphopenia and neutropenia in the total population, and normalised multiple T-cell subset counts in IFNGS test-high patients compared with placebo. Conclusions Anifrolumab treatment reversed IFN-associated changes at the protein and cellular level, indicating multiple modes of activity. Trial registration number NCT01438489.

  • Response to: ‘Comment on: ‘Lupus Low Disease Activity State(LLDAS) attainment discriminates responders in a systemic lupus erythematosus trial: post-hocanalysis of the Phase IIb MUSE trial of Anifrolumab‘ by Eric Morand et al’ by Isenberg.
    Annals of the rheumatic diseases, 2018
    Co-Authors: Eric F. Morand, Anna Berglind, G. Illei, Teodora Trasieva, Raj Tummala

    Abstract:

    The authors thank Professor Isenberg1 for pointing out a drafting error on the manuscript reporting the use of the Lupus Low Disease Activity State (LLDAS) …