Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis

被引:10
|
作者
Coates, Laura C. [1 ]
Ritchlin, Christopher T. [2 ]
Gossec, Laure [3 ,4 ]
Helliwell, Philip S. [5 ]
Rahman, Proton [6 ]
Kollmeier, Alexa P. [7 ]
Xu, Xie L. [7 ]
Shawi, May [8 ]
Karyekar, Chetan S. [9 ]
Contre, Christine [10 ]
Noel, Wim [11 ]
Sheng, Shihong [12 ]
Wang, Yanli [12 ]
Xu, Stephen [12 ]
Mease, Philip J. [13 ,14 ]
机构
[1] Univ Oxford, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Oxford, England
[2] Univ Rochester, Med Ctr, Dept Med Allergy Immunol & Rheumatol, Rochester, NY 14642 USA
[3] Sorbonne Univ, Inst Pierre Louis Epidemiol & Sante Publ, INSERM, Dept Rheumatol, Paris, France
[4] Hop La Pitie Salpetriere, AP HP, Rheumatol Dept, Paris, France
[5] Univ Leeds, Leeds Inst Rheumat & Musculoskeletal Med, Leeds, W Yorkshire, England
[6] Mem Univ Newfoundland, Craig L Dobbin Genet Res Ctr, Discipline Med, Div Rheumatol, St John, NF, Canada
[7] Janssen Res & Dev LLC, Dept Immunol, San Diego, CA USA
[8] Janssen Pharmaceut Co Johnson & Johnson, Rheumatol Global Med Affairs, Immunol, Horsham, PA USA
[9] Janssen Res & Dev LLC, Dept Immunol, Spring House, PA USA
[10] Janssen Cilag, Issy Les Moulineaux, Ile De France, France
[11] Janssen Sci Affairs LLC, Dept Immunol, Brussels, Belgium
[12] Janssen Res & Dev LLC, Dept Stat & Decis Sci, Immunol, Spring House, PA USA
[13] Swedish Med Ctr Providence St Joseph Hlth, Dept Rheumatol Res, Seattle, WA USA
[14] Univ Washington, Rheumatol Res, Seattle, WA 98195 USA
关键词
guselkumab; PsA; composite indices; remission; skin clearance; joint disease; DISEASE-ACTIVITY STATES; INHIBITOR TREATMENT; RESPONDER INDEXES; BIOLOGIC-NAIVE; DOUBLE-BLIND; REMISSION; CRITERIA; TARGET;
D O I
10.1093/rheumatology/keac375
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives To evaluate the efficacy of guselkumab for the treatment of active PsA utilizing composite indices. Methods Data were pooled from the phase 3 DISCOVER-1 (n = 381) and DISCOVER-2 (n = 739) studies. In both studies, patients were randomized 1:1:1 to subcutaneous guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at week 0, week 4, then Q8W; or placebo Q4W with crossover to guselkumab 100 mg Q4W at week 24. Composite indices used to assess efficacy through week 52 included Disease Activity Index for Psoriatic Arthritis (DAPSA), Psoriatic Arthritis Disease Activity Score (PASDAS), minimal disease activity (MDA), and very low disease activity (VLDA). Through week 24, treatment failure rules were applied. Through week 52, non-responder imputation was used for missing data. Results Greater proportions of guselkumab- than placebo-treated patients achieved DAPSA low disease activity (LDA) and remission, PASDAS LDA and VLDA, MDA, and VLDA at week 24 vs placebo (all unadjusted P < 0.05). At week 52, in the guselkumab Q4W and Q8W groups, respectively, response rates were as follows: DAPSA LDA, 54.2% and 52.5%; DAPSA remission, 18.2% and 17.6%; PASDAS LDA, 45.3% and 41.9%; PASDAS VLDA, 16.9% and 19.5%; MDA, 35.9% and 30.7%; and VLDA, 13.1% and 14.4%. In the placebo-crossover-to-guselkumab group, response rates for all composite indices increased after patients switched to guselkumab, from week 24 through week 52. Conclusion Treatment with guselkumab provided robust and sustained benefits across multiple PsA domains through 1 year, indicating that guselkumab is an effective therapy for the diverse manifestations of PsA.
引用
收藏
页码:606 / 616
页数:11
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