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Mehdi Zeraatpishe - One of the best experts on this subject based on the ideXlab platform.
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comparing the efficacy of triamcinolone acetonide iontophoresis versus topical calcipotriol betamethasone dipropionate in treating Nail psoriasis a bilateral controlled clinical trial
Dermatology Research and Practice, 2018Co-Authors: Nasrin Saki, Shahla Hosseinpoor, Alireza Heiran, Ali Akbar Mohammadi, Mehdi ZeraatpisheAbstract:Background and Objective. Psoriasis is a common chronic inflammatory skin disorder affecting any age and gender. The clinical presentation of the Nail Disease depends on the location of the pathology: Nail bed or Nail matrix. We aimed to compare the therapeutic effects of triamcinolone acetonide iontophoresis (TI) and topical calcipotriol/betamethasone dipropionate in the Nail bed and Nail matrix involvements of psoriasis using Nail Psoriasis Severity Index (NAPSI). Materials and Methods. In the present bilateral comparison clinical trial, sixteen patients with clinical diagnosis of Nail psoriasis were enrolled and randomized to receive six monthly TI treatment sessions either on their right or on the left hand target Nails and daily application of topical calcipotriol/betamethasone dipropionate for six months on their other hand. Clinical efficacy was evaluated according to target Nails NAPSI before and after the treatment. Wilcoxon sign-rank test and repeated measures ANOVA were used to compare the efficacy of the treatments. Results. The results did not show any difference between the therapeutic effects of TI and topical calcipotriol/betamethasone dipropionate regarding the Nail bed score (P value = .356), matrix score (P value = .137), and total NAPSI (P-value = .098). Conclusion. Monthly TI has an equal efficacy compared to daily topical calcipotriol/betamethasone dipropionate. It can be used as a safe, easy, and compliant treatment for Nail psoriasis. This study is registered under IRCT2017050233778N1 .
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Comparing the Efficacy of Triamcinolone Acetonide Iontophoresis versus Topical Calcipotriol/Betamethasone Dipropionate in Treating Nail Psoriasis: A Bilateral Controlled Clinical Trial
Hindawi Limited, 2018Co-Authors: Nasrin Saki, Shahla Hosseinpoor, Alireza Heiran, Ali Mohammadi, Mehdi ZeraatpisheAbstract:Background and Objective. Psoriasis is a common chronic inflammatory skin disorder affecting any age and gender. The clinical presentation of the Nail Disease depends on the location of the pathology: Nail bed or Nail matrix. We aimed to compare the therapeutic effects of triamcinolone acetonide iontophoresis (TI) and topical calcipotriol/betamethasone dipropionate in the Nail bed and Nail matrix involvements of psoriasis using Nail Psoriasis Severity Index (NAPSI). Materials and Methods. In the present bilateral comparison clinical trial, sixteen patients with clinical diagnosis of Nail psoriasis were enrolled and randomized to receive six monthly TI treatment sessions either on their right or on the left hand target Nails and daily application of topical calcipotriol/betamethasone dipropionate for six months on their other hand. Clinical efficacy was evaluated according to target Nails NAPSI before and after the treatment. Wilcoxon sign-rank test and repeated measures ANOVA were used to compare the efficacy of the treatments. Results. The results did not show any difference between the therapeutic effects of TI and topical calcipotriol/betamethasone dipropionate regarding the Nail bed score (P value = .356), matrix score (P value = .137), and total NAPSI (P-value = .098). Conclusion. Monthly TI has an equal efficacy compared to daily topical calcipotriol/betamethasone dipropionate. It can be used as a safe, easy, and compliant treatment for Nail psoriasis. This study is registered under IRCT2017050233778N1
Nasrin Saki - One of the best experts on this subject based on the ideXlab platform.
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comparing the efficacy of triamcinolone acetonide iontophoresis versus topical calcipotriol betamethasone dipropionate in treating Nail psoriasis a bilateral controlled clinical trial
Dermatology Research and Practice, 2018Co-Authors: Nasrin Saki, Shahla Hosseinpoor, Alireza Heiran, Ali Akbar Mohammadi, Mehdi ZeraatpisheAbstract:Background and Objective. Psoriasis is a common chronic inflammatory skin disorder affecting any age and gender. The clinical presentation of the Nail Disease depends on the location of the pathology: Nail bed or Nail matrix. We aimed to compare the therapeutic effects of triamcinolone acetonide iontophoresis (TI) and topical calcipotriol/betamethasone dipropionate in the Nail bed and Nail matrix involvements of psoriasis using Nail Psoriasis Severity Index (NAPSI). Materials and Methods. In the present bilateral comparison clinical trial, sixteen patients with clinical diagnosis of Nail psoriasis were enrolled and randomized to receive six monthly TI treatment sessions either on their right or on the left hand target Nails and daily application of topical calcipotriol/betamethasone dipropionate for six months on their other hand. Clinical efficacy was evaluated according to target Nails NAPSI before and after the treatment. Wilcoxon sign-rank test and repeated measures ANOVA were used to compare the efficacy of the treatments. Results. The results did not show any difference between the therapeutic effects of TI and topical calcipotriol/betamethasone dipropionate regarding the Nail bed score (P value = .356), matrix score (P value = .137), and total NAPSI (P-value = .098). Conclusion. Monthly TI has an equal efficacy compared to daily topical calcipotriol/betamethasone dipropionate. It can be used as a safe, easy, and compliant treatment for Nail psoriasis. This study is registered under IRCT2017050233778N1 .
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Comparing the Efficacy of Triamcinolone Acetonide Iontophoresis versus Topical Calcipotriol/Betamethasone Dipropionate in Treating Nail Psoriasis: A Bilateral Controlled Clinical Trial
Hindawi Limited, 2018Co-Authors: Nasrin Saki, Shahla Hosseinpoor, Alireza Heiran, Ali Mohammadi, Mehdi ZeraatpisheAbstract:Background and Objective. Psoriasis is a common chronic inflammatory skin disorder affecting any age and gender. The clinical presentation of the Nail Disease depends on the location of the pathology: Nail bed or Nail matrix. We aimed to compare the therapeutic effects of triamcinolone acetonide iontophoresis (TI) and topical calcipotriol/betamethasone dipropionate in the Nail bed and Nail matrix involvements of psoriasis using Nail Psoriasis Severity Index (NAPSI). Materials and Methods. In the present bilateral comparison clinical trial, sixteen patients with clinical diagnosis of Nail psoriasis were enrolled and randomized to receive six monthly TI treatment sessions either on their right or on the left hand target Nails and daily application of topical calcipotriol/betamethasone dipropionate for six months on their other hand. Clinical efficacy was evaluated according to target Nails NAPSI before and after the treatment. Wilcoxon sign-rank test and repeated measures ANOVA were used to compare the efficacy of the treatments. Results. The results did not show any difference between the therapeutic effects of TI and topical calcipotriol/betamethasone dipropionate regarding the Nail bed score (P value = .356), matrix score (P value = .137), and total NAPSI (P-value = .098). Conclusion. Monthly TI has an equal efficacy compared to daily topical calcipotriol/betamethasone dipropionate. It can be used as a safe, easy, and compliant treatment for Nail psoriasis. This study is registered under IRCT2017050233778N1
Philip J. Mease - One of the best experts on this subject based on the ideXlab platform.
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sat0388 characterization of patients with psoriatic arthritis and Nail psoriasis data from the corrona psoriatic arthritis spondyloarthritis psa spa registry
Annals of the Rheumatic Diseases, 2019Co-Authors: Philip J. Mease, Mei Liu, Sabrina Rebello, Robert Mclean, Blessing Dube, Meghan Glynn, Peter Hur, Alexis OgdieAbstract:Background Nail Disease is an important feature of PsA and may even precede the Disease by many years.1 Nail psoriasis is considered one of the 6 Disease domains of PsA2; however, there have been limited real-world studies that have examined characteristics of patients with PsA and Nail psoriasis, particularly in the United States. Objectives To characterize the Disease activity, quality of life, and work productivity of patients with PsA with and without Nail psoriasis in the US-based Corrona PsA/SpA Registry. Methods This study included all patients in the Corrona PsA/SpA registry enrolled between March 2013 and October 2018 with a diagnosis of PsA who had non-missing data on physician-reported Nail psoriasis. Patients were stratified by presence vs absence of Nail psoriasis at the time of enrollment, defined as a non-zero response on the Nail psoriasis visual analog scale (VAS) of 0–100. Descriptive analyses of patient demographics, Disease activity, quality of life, and work productivity were assessed at enrollment and compared between Nail psoriasis groups using t-tests or Wilcoxon rank-sum tests for continuous variables and χ2 or Fisher’s exact tests for categorical variables. Results A total of 2841 patients with PsA met the inclusion criteria, including 1152 patients (40.5%) with Nail psoriasis and 1689 patients (59.5%) without Nail psoriasis at enrollment. Patients with and without Nail psoriasis were similar in terms of demographic and clinical characteristics; however, patients with Nail psoriasis were slightly younger (53.1 vs 54.4 years) and more likely to be male (51.9% vs 44.1%) and have a higher history of depression (17.8% vs 13.3%) compared with patients without Nail psoriasis (all P Conclusion PsA patients with Nail psoriasis at the time of registry enrollment had worse Disease activity, quality of life, and work productivity compared with those patients without Nail involvement. These findings emphasize the importance of identification and management of Nail Disease in patients with PsA. References [1] Gladman DD, et al. Ann Rheum Dis. 2005;64(suppl 2):ii14-7. [2] Coates LC, et al. Arthritis Rheumatol. 2016;68(5):1060-71. Acknowledgement This study was sponsored by Corrona, LLC. Corrona is supported through contracted subscriptions with multiple pharmaceutical companies. The abstract was a collaborative effort between Corrona and Novartis, with financial support provided by Novartis. Disclosure of Interests Philip J Mease Grant/research support from: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Consultant for: AbbVie, Amgen, BMS, Galapagos, Gilead Sciences, Inc., Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer and UCB, Peter Hur Employee of: Peter Hur is an employee of Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA, Mei Liu Employee of: M. Liu is an employee of Corrona, LLC., Sabrina Rebello Employee of: Corrona, LLC, Robert McLean: None declared, Blessing Dube Employee of: B. Dube is an employee of Corrona, LLC., Meghan Glynn Employee of: M. Glynn is an employee of Corrona, LLC., Alexis Ogdie Grant/research support from: (To my university) Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Grant/research support from: Novartis, Pfizer, Consultant for: AbbVie, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly and Company, Novartis, Pfizer, and Takeda, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Corrona, Eli Lilly, Novartis, Pfizer Inc, Takeda, Consultant for: Abbvie, Amgen, BMS, Celgene, Corrona, Lilly, Novartis, Pfizer, Takeda, Consultant for: Abbvie, Amgen, BMS, Celgene, Corrona, Lilly, Novartis, Pfizer, Takeda
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design and rationale of the study of etanercept and methotrexate in combination or as monotherapy in subjects with psoriatic arthritis seam psa
RMD Open, 2018Co-Authors: Philip J. Mease, Dafna D. Gladman, Laura C Coates, Ahmed S Samad, Lyrica Liu, Girish A Aras, David H Collier, James B ChungAbstract:Objective To evaluate the efficacy of etanercept and methotrexate as monotherapies and as combination therapy in subjects with active psoriatic arthritis (PsA). Methods The Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA) is an ongoing, global, double-blind, 48-week, randomised, controlled study. Subjects are randomised (1:1:1) to etanercept monotherapy, methotrexate monotherapy or etanercept-methotrexate combination therapy. Endpoints include rates of ACR20 response and Minimal Disease Activity, measures to characterise extra-articular manifestations (dactylitis, enthesitis, Nail Disease) and safety. Conclusion SEAM-PsA will characterise the effects of etanercept with and without background methotrexate and methotrexate alone on PsA manifestations, and provide information of practical importance to clinicians on the optimal treatment of PsA.
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group for research and assessment of psoriasis and psoriatic arthritis 2015 treatment recommendations for psoriatic arthritis
Arthritis & Rheumatism, 2016Co-Authors: Laura C Coates, Arthur Kavanaugh, Philip J. Mease, Maria Laura Acostafelquer, Enrique R Soriano, April W Armstrong, W Bautistamolano, Wolfhenning Boehncke, Willemina Campbell, Alberto CauliAbstract:Objective To update the 2009 Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) treatment recommendations for the spectrum of manifestations affecting patients with psoriatic arthritis (PsA). Methods GRAPPA rheumatologists, dermatologists, and PsA patients drafted overarching principles for the management of PsA, based on consensus achieved at face-to-face meetings and via online surveys. We conducted literature reviews regarding treatment for the key domains of PsA (arthritis, spondylitis, enthesitis, dactylitis, skin Disease, and Nail Disease) and convened a new group to identify pertinent comorbidities and their effect on treatment. Finally, we drafted treatment recommendations for each of the clinical manifestations and assessed the level of agreement for the overarching principles and treatment recommendations among GRAPPA members, using an online questionnaire. Results Six overarching principles had ≥80% agreement among both health care professionals (n = 135) and patient research partners (n = 10). We developed treatment recommendations and a schema incorporating these principles for arthritis, spondylitis, enthesitis, dactylitis, skin Disease, Nail Disease, and comorbidities in the setting of PsA, using the Grading of Recommendations, Assessment, Development and Evaluation process. Agreement of >80% was reached for approval of the individual recommendations and the overall schema. Conclusion We present overarching principles and updated treatment recommendations for the key manifestations of PsA, including related comorbidities, based on a literature review and consensus of GRAPPA members (rheumatologists, dermatologists, other health care providers, and patient research partners). Further updates are anticipated as the therapeutic landscape in PsA evolves.
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treatment recommendations for psoriatic arthritis
Annals of the Rheumatic Diseases, 2009Co-Authors: Christopher T Ritchlin, Dafna D. Gladman, Arthur Kavanaugh, Philip J. Mease, Oliver Fitzgerald, Wolfhenning Boehncke, P Helliwell, K De Vlam, David Fiorentino, Alice B GottliebAbstract:Objective: To develop comprehensive recommendations for the treatment of the various clinical manifestations of psoriatic arthritis (PsA) based on evidence obtained from a systematic review of the literature and from consensus opinion. Methods: Formal literature reviews of treatment for the most significant discrete clinical manifestations of PsA (skin and Nails, peripheral arthritis, axial Disease, dactylitis and enthesitis) were performed and published by members of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). Treatment recommendations were drafted for each of the clinical manifestations by rheumatologists, dermatologists and PsA patients based on the literature reviews and consensus opinion. The level of agreement for the individual treatment recommendations among GRAPPA members was assessed with an online questionnaire. Results: Treatment recommendations were developed for peripheral arthritis, axial Disease, psoriasis, Nail Disease, dactylitis and enthesitis in the setting of PsA. In rotal, 19 recommendations were drafted, and over 80% agreement was obtained on 16 of them. In addition, a grid that factors Disease severity into each of the different Disease manifestations was developed to help the clinician with treatment decisions for the individual patient from an evidenced-based perspective. Conclusions: Treatment recommendations for the cardinal physical manifestations of PsA were developed based on a literature review and consensus between rheumatologists and dermatologists. In addition, a grid was established to assist in therapeutic reasoning and decision making for individual patients. It is anticipated that periodic updates will take place using this framework as new data become available.
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golimumab a new human tumor necrosis factor alpha antibody administered every four weeks as a subcutaneous injection in psoriatic arthritis twenty four week efficacy and safety results of a randomized placebo controlled study
Arthritis & Rheumatism, 2009Co-Authors: Arthur Kavanaugh, J. Zrubek, Juan J Gomezreino, Surekha Mudivarthy, Kim Papp, Dafna D. Gladman, Iain B Mcinnes, Gerald G. Krueger, Philip J. Mease, Michael MackAbstract:Objective To assess the efficacy and safety of golimumab in patients with active psoriatic arthritis (PsA). Methods Adult patients with PsA who had at least 3 swollen and 3 tender joints and active psoriasis were randomly assigned to receive subcutaneous injections of placebo (n = 113), golimumab 50 mg (n = 146), or golimumab 100 mg (n = 146) every 4 weeks through week 20. Efficacy assessments through week 24 included the American College of Rheumatology 20% improvement criteria (ACR20), the Psoriasis Area and Severity Index (PASI) in patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, the Short Form 36 Health Survey (SF-36), the disability index of the Health Assessment Questionnaire (HAQ), the Nail Psoriasis Severity Index (NAPSI), the physician's global assessment of psoriatic Nail Disease, and enthesitis (using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score [MASES] index). Results At week 14, 48% of all patients receiving golimumab, 51% of patients receiving golimumab 50 mg, and 45% of patients receiving golimumab 100 mg achieved an ACR20 response (the primary end point), compared with 9% of patients receiving placebo (P < 0.001 for all comparisons). Among the 74% of patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, 40% of those in the golimumab 50 mg group and 58% of those in the golimumab 100 mg group had at least 75% improvement in the PASI at week 14 (major secondary end point), compared with 3% of placebo-treated patients (P < 0.001 for both doses). Significant improvement was observed for other major secondary end points (the HAQ and the SF-36), the NAPSI, the physician's global assessment of psoriatric Nail Disease, and the PsA-modified MASES index in each golimumab group compared with placebo. This efficacy was maintained through week 24. Golimumab was generally well tolerated. Conclusion Treatment with golimumab at doses of 50 mg and 100 mg significantly improved active PsA and associated skin and Nail psoriasis through week 24.
Dafna D. Gladman - One of the best experts on this subject based on the ideXlab platform.
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design and rationale of the study of etanercept and methotrexate in combination or as monotherapy in subjects with psoriatic arthritis seam psa
RMD Open, 2018Co-Authors: Philip J. Mease, Dafna D. Gladman, Laura C Coates, Ahmed S Samad, Lyrica Liu, Girish A Aras, David H Collier, James B ChungAbstract:Objective To evaluate the efficacy of etanercept and methotrexate as monotherapies and as combination therapy in subjects with active psoriatic arthritis (PsA). Methods The Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA) is an ongoing, global, double-blind, 48-week, randomised, controlled study. Subjects are randomised (1:1:1) to etanercept monotherapy, methotrexate monotherapy or etanercept-methotrexate combination therapy. Endpoints include rates of ACR20 response and Minimal Disease Activity, measures to characterise extra-articular manifestations (dactylitis, enthesitis, Nail Disease) and safety. Conclusion SEAM-PsA will characterise the effects of etanercept with and without background methotrexate and methotrexate alone on PsA manifestations, and provide information of practical importance to clinicians on the optimal treatment of PsA.
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Psoriatic Arthritis: Phenotypic Variance and Nosology
Current Rheumatology Reports, 2013Co-Authors: Lihi Eder, Dafna D. GladmanAbstract:Psoriatic arthritis (PsA) has been recognized as a distinct entity different from rheumatoid arthritis. Classification and phenotyping of PsA have progressed substantially since the first classification criteria of the Disease were published in 1973 by Moll and Wright. The initial Disease patterns described by Moll and Wright have been found to overlap and change over time. There has been controversy about whether these should be maintained or whether the phenotype of PsA should include peripheral and axial Disease only. PsA is a multifaceted Disease that can present as different clinical phenotypes: peripheral arthritis, axial Disease, skin and Nail Disease, dactylitis, and enthesitis. Development of the high-sensitivity and high-specificity CASPAR criteria was the first step to conducting high-quality trials and observational studies in the field.
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treatment recommendations for psoriatic arthritis
Annals of the Rheumatic Diseases, 2009Co-Authors: Christopher T Ritchlin, Dafna D. Gladman, Arthur Kavanaugh, Philip J. Mease, Oliver Fitzgerald, Wolfhenning Boehncke, P Helliwell, K De Vlam, David Fiorentino, Alice B GottliebAbstract:Objective: To develop comprehensive recommendations for the treatment of the various clinical manifestations of psoriatic arthritis (PsA) based on evidence obtained from a systematic review of the literature and from consensus opinion. Methods: Formal literature reviews of treatment for the most significant discrete clinical manifestations of PsA (skin and Nails, peripheral arthritis, axial Disease, dactylitis and enthesitis) were performed and published by members of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). Treatment recommendations were drafted for each of the clinical manifestations by rheumatologists, dermatologists and PsA patients based on the literature reviews and consensus opinion. The level of agreement for the individual treatment recommendations among GRAPPA members was assessed with an online questionnaire. Results: Treatment recommendations were developed for peripheral arthritis, axial Disease, psoriasis, Nail Disease, dactylitis and enthesitis in the setting of PsA. In rotal, 19 recommendations were drafted, and over 80% agreement was obtained on 16 of them. In addition, a grid that factors Disease severity into each of the different Disease manifestations was developed to help the clinician with treatment decisions for the individual patient from an evidenced-based perspective. Conclusions: Treatment recommendations for the cardinal physical manifestations of PsA were developed based on a literature review and consensus between rheumatologists and dermatologists. In addition, a grid was established to assist in therapeutic reasoning and decision making for individual patients. It is anticipated that periodic updates will take place using this framework as new data become available.
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golimumab a new human tumor necrosis factor α antibody administered every four weeks as a subcutaneous injection in psoriatic arthritis twenty four week efficacy and safety results of a randomized placebo controlled study
Arthritis & Rheumatism, 2009Co-Authors: Arthur Kavanaugh, J. Zrubek, Juan J Gomezreino, Surekha Mudivarthy, Kim Papp, Dafna D. Gladman, Iain B Mcinnes, Gerald G. Krueger, Michael MackAbstract:Objective To assess the efficacy and safety of golimumab in patients with active psoriatic arthritis (PsA). Methods Adult patients with PsA who had at least 3 swollen and 3 tender joints and active psoriasis were randomly assigned to receive subcutaneous injections of placebo (n = 113), golimumab 50 mg (n = 146), or golimumab 100 mg (n = 146) every 4 weeks through week 20. Efficacy assessments through week 24 included the American College of Rheumatology 20% improvement criteria (ACR20), the Psoriasis Area and Severity Index (PASI) in patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, the Short Form 36 Health Survey (SF-36), the disability index of the Health Assessment Questionnaire (HAQ), the Nail Psoriasis Severity Index (NAPSI), the physician's global assessment of psoriatic Nail Disease, and enthesitis (using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score [MASES] index). Results At week 14, 48% of all patients receiving golimumab, 51% of patients receiving golimumab 50 mg, and 45% of patients receiving golimumab 100 mg achieved an ACR20 response (the primary end point), compared with 9% of patients receiving placebo (P < 0.001 for all comparisons). Among the 74% of patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, 40% of those in the golimumab 50 mg group and 58% of those in the golimumab 100 mg group had at least 75% improvement in the PASI at week 14 (major secondary end point), compared with 3% of placebo-treated patients (P < 0.001 for both doses). Significant improvement was observed for other major secondary end points (the HAQ and the SF-36), the NAPSI, the physician's global assessment of psoriatric Nail Disease, and the PsA-modified MASES index in each golimumab group compared with placebo. This efficacy was maintained through week 24. Golimumab was generally well tolerated. Conclusion Treatment with golimumab at doses of 50 mg and 100 mg significantly improved active PsA and associated skin and Nail psoriasis through week 24.
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golimumab a new human tumor necrosis factor alpha antibody administered every four weeks as a subcutaneous injection in psoriatic arthritis twenty four week efficacy and safety results of a randomized placebo controlled study
Arthritis & Rheumatism, 2009Co-Authors: Arthur Kavanaugh, J. Zrubek, Juan J Gomezreino, Surekha Mudivarthy, Kim Papp, Dafna D. Gladman, Iain B Mcinnes, Gerald G. Krueger, Philip J. Mease, Michael MackAbstract:Objective To assess the efficacy and safety of golimumab in patients with active psoriatic arthritis (PsA). Methods Adult patients with PsA who had at least 3 swollen and 3 tender joints and active psoriasis were randomly assigned to receive subcutaneous injections of placebo (n = 113), golimumab 50 mg (n = 146), or golimumab 100 mg (n = 146) every 4 weeks through week 20. Efficacy assessments through week 24 included the American College of Rheumatology 20% improvement criteria (ACR20), the Psoriasis Area and Severity Index (PASI) in patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, the Short Form 36 Health Survey (SF-36), the disability index of the Health Assessment Questionnaire (HAQ), the Nail Psoriasis Severity Index (NAPSI), the physician's global assessment of psoriatic Nail Disease, and enthesitis (using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score [MASES] index). Results At week 14, 48% of all patients receiving golimumab, 51% of patients receiving golimumab 50 mg, and 45% of patients receiving golimumab 100 mg achieved an ACR20 response (the primary end point), compared with 9% of patients receiving placebo (P < 0.001 for all comparisons). Among the 74% of patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, 40% of those in the golimumab 50 mg group and 58% of those in the golimumab 100 mg group had at least 75% improvement in the PASI at week 14 (major secondary end point), compared with 3% of placebo-treated patients (P < 0.001 for both doses). Significant improvement was observed for other major secondary end points (the HAQ and the SF-36), the NAPSI, the physician's global assessment of psoriatric Nail Disease, and the PsA-modified MASES index in each golimumab group compared with placebo. This efficacy was maintained through week 24. Golimumab was generally well tolerated. Conclusion Treatment with golimumab at doses of 50 mg and 100 mg significantly improved active PsA and associated skin and Nail psoriasis through week 24.
Michael Mack - One of the best experts on this subject based on the ideXlab platform.
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golimumab a new human tumor necrosis factor α antibody administered every four weeks as a subcutaneous injection in psoriatic arthritis twenty four week efficacy and safety results of a randomized placebo controlled study
Arthritis & Rheumatism, 2009Co-Authors: Arthur Kavanaugh, J. Zrubek, Juan J Gomezreino, Surekha Mudivarthy, Kim Papp, Dafna D. Gladman, Iain B Mcinnes, Gerald G. Krueger, Michael MackAbstract:Objective To assess the efficacy and safety of golimumab in patients with active psoriatic arthritis (PsA). Methods Adult patients with PsA who had at least 3 swollen and 3 tender joints and active psoriasis were randomly assigned to receive subcutaneous injections of placebo (n = 113), golimumab 50 mg (n = 146), or golimumab 100 mg (n = 146) every 4 weeks through week 20. Efficacy assessments through week 24 included the American College of Rheumatology 20% improvement criteria (ACR20), the Psoriasis Area and Severity Index (PASI) in patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, the Short Form 36 Health Survey (SF-36), the disability index of the Health Assessment Questionnaire (HAQ), the Nail Psoriasis Severity Index (NAPSI), the physician's global assessment of psoriatic Nail Disease, and enthesitis (using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score [MASES] index). Results At week 14, 48% of all patients receiving golimumab, 51% of patients receiving golimumab 50 mg, and 45% of patients receiving golimumab 100 mg achieved an ACR20 response (the primary end point), compared with 9% of patients receiving placebo (P < 0.001 for all comparisons). Among the 74% of patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, 40% of those in the golimumab 50 mg group and 58% of those in the golimumab 100 mg group had at least 75% improvement in the PASI at week 14 (major secondary end point), compared with 3% of placebo-treated patients (P < 0.001 for both doses). Significant improvement was observed for other major secondary end points (the HAQ and the SF-36), the NAPSI, the physician's global assessment of psoriatric Nail Disease, and the PsA-modified MASES index in each golimumab group compared with placebo. This efficacy was maintained through week 24. Golimumab was generally well tolerated. Conclusion Treatment with golimumab at doses of 50 mg and 100 mg significantly improved active PsA and associated skin and Nail psoriasis through week 24.
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golimumab a new human tumor necrosis factor alpha antibody administered every four weeks as a subcutaneous injection in psoriatic arthritis twenty four week efficacy and safety results of a randomized placebo controlled study
Arthritis & Rheumatism, 2009Co-Authors: Arthur Kavanaugh, J. Zrubek, Juan J Gomezreino, Surekha Mudivarthy, Kim Papp, Dafna D. Gladman, Iain B Mcinnes, Gerald G. Krueger, Philip J. Mease, Michael MackAbstract:Objective To assess the efficacy and safety of golimumab in patients with active psoriatic arthritis (PsA). Methods Adult patients with PsA who had at least 3 swollen and 3 tender joints and active psoriasis were randomly assigned to receive subcutaneous injections of placebo (n = 113), golimumab 50 mg (n = 146), or golimumab 100 mg (n = 146) every 4 weeks through week 20. Efficacy assessments through week 24 included the American College of Rheumatology 20% improvement criteria (ACR20), the Psoriasis Area and Severity Index (PASI) in patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, the Short Form 36 Health Survey (SF-36), the disability index of the Health Assessment Questionnaire (HAQ), the Nail Psoriasis Severity Index (NAPSI), the physician's global assessment of psoriatic Nail Disease, and enthesitis (using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score [MASES] index). Results At week 14, 48% of all patients receiving golimumab, 51% of patients receiving golimumab 50 mg, and 45% of patients receiving golimumab 100 mg achieved an ACR20 response (the primary end point), compared with 9% of patients receiving placebo (P < 0.001 for all comparisons). Among the 74% of patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, 40% of those in the golimumab 50 mg group and 58% of those in the golimumab 100 mg group had at least 75% improvement in the PASI at week 14 (major secondary end point), compared with 3% of placebo-treated patients (P < 0.001 for both doses). Significant improvement was observed for other major secondary end points (the HAQ and the SF-36), the NAPSI, the physician's global assessment of psoriatric Nail Disease, and the PsA-modified MASES index in each golimumab group compared with placebo. This efficacy was maintained through week 24. Golimumab was generally well tolerated. Conclusion Treatment with golimumab at doses of 50 mg and 100 mg significantly improved active PsA and associated skin and Nail psoriasis through week 24.
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golimumab a new human tumor necrosis factor α antibody administered every four weeks as a subcutaneous injection in psoriatic arthritis twenty four week efficacy and safety results of a randomized placebo controlled study
Arthritis & Rheumatism, 2009Co-Authors: Arthur Kavanaugh, J. Zrubek, Juan J Gomezreino, Surekha Mudivarthy, Dafna D. Gladman, Iain B Mcinnes, Gerald G. Krueger, Philip J. Mease, Kim A Papp, Michael MackAbstract:To assess the efficacy and safety of golimumab in patients with active psoriatic arthritis (PsA). Methods. Adult patients with PsA who had at least 3 swollen and 3 tender joints and active psoriasis were randomly assigned to receive subcutaneous injections of placebo (n = 113), golimumab 50 mg (n = 146), or golimumab 100 mg (n = 146) every 4 weeks through week 20. Efficacy assessments through week 24 included the American College of Rheumatology 20% improvement criteria (ACR20), the Psoriasis Area and Severity Index (PASI) in patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, the Short Form 36 Health Survey (SF-36), the disability index of the Health Assessment Questionnaire (HAQ), the Nail Psoriasis Severity Index (NAPSI), the physician's global assessment of psoriatic Nail Disease, and enthesitis (using the PsA-modified Maastricht Ankylosing Spondylitis Enthesitis Score [MASES] index). Results. At week 14, 48% of all patients receiving golimumab, 51% of patients receiving golimumab 50 mg, and 45% of patients receiving golimumab 100 mg achieved an ACR20 response (the primary end point), compared with 9% of patients receiving placebo (P < 0.001 for all comparisons). Among the 74% of patients in whom at least 3% of the body surface area was affected by psoriasis at baseline, 40% of those in the golimumab 50 mg group and 58% of those in the golimumab 100 mg group had at least 75% improvement in the PASI at week 14 (major secondary end point), compared with 3% of placebo-treated patients (P < 0.001 for both doses). Significant improvement was observed for other major secondary end points (the HAQ and the SF-36), the NAPSI, the physician's global assessment of psoriatric Nail Disease, and the PsA-modified MASES index in each golimumab group com- pared with placebo. This efficacy was maintained through week 24. Golimumab was generally well tolerated. Conclusion. Treatment with golimumab at doses of 50 mg and 100 mg significantly improved active PsA and associated skin and Nail psoriasis through week 24. © 2009, American College of Rheumatology.
