학술논문
Withdrawing Ixekizumab in Patients With Psoriatic Arthritis Who Achieved Minimal Disease Activity: Results From a Randomized, Double‐Blind Withdrawal Study.
Document Type
Article
Author
Coates, Laura C.; Pillai, Sreekumar G.; Tahir, Hasan; Valter, Ivo; Chandran, Vinod; Kameda, Hideto; Okada, Masato; Kerr, Lisa; Alves, Denise; Park, So Young; Adams, David H.; Gallo, Gaia; Hufford, Matthew M.; Hojnik, Maja; Mease, Philip J.; Kavanaugh, Arthur; Ahmed, Khalid; Barkham, Nicholas; Belhorn, Linda; Bichovska, Daniela
Source
Subject
*THERAPEUTIC use of monoclonal antibodies
*PSORIATIC arthritis
*RESEARCH
*CONFIDENCE intervals
*MEDICAL cooperation
*MONOCLONAL antibodies
*RANDOMIZED controlled trials
*SEVERITY of illness index
*BLIND experiment
*DESCRIPTIVE statistics
*TERMINATION of treatment
*STATISTICAL sampling
*DISEASE remission
*DETOXIFICATION (Substance abuse treatment)
DISEASE relapse prevention
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Language
ISSN
2326-5191
Abstract
Objective: To evaluate the effect of withdrawing ixekizumab in patients with psoriatic arthritis (PsA) in whom minimal disease activity (MDA) has been achieved after open‐label ixekizumab treatment. Methods: SPIRIT‐P3 was a multicenter, randomized, double‐blind withdrawal study of biologic treatment–naive adult patients with PsA who were treated with open‐label ixekizumab for 36 weeks (160 mg at week 0, then 80 mg every 2 weeks). Patients in whom MDA was sustained for >3 consecutive months were randomized 1:1, between weeks 36 and 64, to undergo blinded withdrawal of ixekizumab treatment (placebo) or to continue ixekizumab treatment every 2 weeks up to week 104. The primary efficacy end point was time to relapse (loss of MDA) for randomized patients. Patients who experienced a relapse were re‐treated with ixekizumab every 2 weeks up to week 104. Results: A total of 394 patients were enrolled and received open‐label ixekizumab every 2 weeks. Of those patients, 158 (40%) achieved sustained MDA and were randomized to undergo withdrawal of ixekizumab treatment (placebo every 2 weeks; n = 79) or to continue ixekizumab treatment every 2 weeks (n = 79). Disease relapse occurred more rapidly with treatment withdrawal (median 22.3 weeks [95% confidence interval (95% CI) 16.1–28.3]) compared to those who continued treatment with ixekizumab (median not estimable; P < 0.0001). Sixty‐seven patients (85%) compared to 30 patients (38%) experienced relapse in the placebo group and the continued treatment group, respectively. Median time to achieving MDA again with re‐treatment was 4.1 weeks (95% CI 4.1–4.3); in 64 of 67 patients (96%) who experienced relapse with treatment withdrawal, MDA was achieved again with re‐treatment. Safety was consistent with the known safety profile for ixekizumab. Conclusion: Continued ixekizumab therapy is superior to ixekizumab withdrawal in maintaining low disease activity in biologic treatment–naive patients with PsA. Re‐treatment with ixekizumab following a relapse may restore disease control in cases of treatment interruption. [ABSTRACT FROM AUTHOR]