TY - JOUR
T1 - Secukinumab for Long-Term Treatment of Psoriatic Arthritis
T2 - A Two-Year Followup From a Phase III, Randomized, Double-Blind Placebo-Controlled Study
AU - for the FUTURE-1 Study Group
AU - Kavanaugh, Arthur
AU - Mease, Philip J.
AU - Reimold, Andreas M.
AU - Tahir, Hasan
AU - Rech, Jürgen
AU - Hall, Stephen
AU - Geusens, Piet
AU - Wang, Zailong
AU - Pricop, Luminita
AU - Mpofu, Shephard
N1 - Publisher Copyright:
© 2016, American College of Rheumatology
PY - 2017/3/1
Y1 - 2017/3/1
N2 - Objective: To assess the 2-year efficacy and safety of the interleukin-17A inhibitor, secukinumab, in active psoriatic arthritis (PsA). Methods: In the FUTURE-1 study, 606 patients with active PsA were randomized to secukinumab 10 mg/kg intravenously at baseline, and at weeks 2 and 4, followed by 150 mg or 75 mg subcutaneously (SC) every 4 weeks from week 8, or matching placebo. Patients receiving placebo were re-randomized to secukinumab 150 mg or 75 mg SC from week 16 or week 24, depending upon clinical response. Treatment continued to week 104. Exploratory analysis of all primary and secondary end points, on an intent-to-treat basis, continued to week 104. Results: A total of 476 patients (78.5%) completed 104 weeks of treatment. Secukinumab showed sustained efficacy across multiple domains of PsA through week 104, including signs and symptoms, disease activity, quality of life, physical function, skin symptoms, dactylitis, and enthesitis. American College of Rheumatology criteria for 20% improvement response rates were 66.8% with secukinumab 150 mg and 58.6% with secukinumab 75 mg at week 104; Psoriasis Area and Severity Index criteria for 75% improvement response rates were 74.6% and 63.0%, respectively (multiple imputed data). At week 104, 84.3% of patients in the secukinumab 150 mg group and 83.8% in the secukinumab 75 mg group showed no radiographic disease progression (observed data). No new or unexpected safety signals were reported during 2 years of treatment. Immunogenicity to secukinumab was low. Conclusion: Secukinumab provided sustained improvements in PsA at 2 years, with very little radiographic progression. Treatment was well tolerated over the long term.
AB - Objective: To assess the 2-year efficacy and safety of the interleukin-17A inhibitor, secukinumab, in active psoriatic arthritis (PsA). Methods: In the FUTURE-1 study, 606 patients with active PsA were randomized to secukinumab 10 mg/kg intravenously at baseline, and at weeks 2 and 4, followed by 150 mg or 75 mg subcutaneously (SC) every 4 weeks from week 8, or matching placebo. Patients receiving placebo were re-randomized to secukinumab 150 mg or 75 mg SC from week 16 or week 24, depending upon clinical response. Treatment continued to week 104. Exploratory analysis of all primary and secondary end points, on an intent-to-treat basis, continued to week 104. Results: A total of 476 patients (78.5%) completed 104 weeks of treatment. Secukinumab showed sustained efficacy across multiple domains of PsA through week 104, including signs and symptoms, disease activity, quality of life, physical function, skin symptoms, dactylitis, and enthesitis. American College of Rheumatology criteria for 20% improvement response rates were 66.8% with secukinumab 150 mg and 58.6% with secukinumab 75 mg at week 104; Psoriasis Area and Severity Index criteria for 75% improvement response rates were 74.6% and 63.0%, respectively (multiple imputed data). At week 104, 84.3% of patients in the secukinumab 150 mg group and 83.8% in the secukinumab 75 mg group showed no radiographic disease progression (observed data). No new or unexpected safety signals were reported during 2 years of treatment. Immunogenicity to secukinumab was low. Conclusion: Secukinumab provided sustained improvements in PsA at 2 years, with very little radiographic progression. Treatment was well tolerated over the long term.
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U2 - 10.1002/acr.23111
DO - 10.1002/acr.23111
M3 - Article
C2 - 27696786
AN - SCOPUS:85013898012
SN - 2151-464X
VL - 69
SP - 347
EP - 355
JO - Arthritis Care and Research
JF - Arthritis Care and Research
IS - 3
ER -