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Withdrawing Ixekizumab in Patients With Psoriatic Arthritis Who Achieved Minimal Disease Activity: Results From a
Laura C Coates1, Sreekumar G Pillai2, Hasan Tahir3
1University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences and Oxford University Hospitals NHS Foundation Trust, NIHR Oxford Biomedical Research Centre, Oxford, UK.
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.
Insights
Continuing ixekizumab treatment is more effective than withdrawal for maintaining minimal disease activity in psoriatic arthritis patients. Re-treatment can restore disease control after interruption.
Area of Science:
- Rheumatology
- Immunology
- Clinical Trials
Background:
- Psoriatic arthritis (PsA) is a chronic inflammatory condition.
- Achieving minimal disease activity (MDA) is a key treatment goal in PsA.
- The efficacy of ixekizumab withdrawal after achieving MDA is not well-established.
Purpose of the Study:
- To evaluate the impact of discontinuing ixekizumab in PsA patients who have achieved MDA.
- To compare the time to relapse between ixekizumab withdrawal and continued treatment groups.
Main Methods:
- A multicenter, randomized, double-blind withdrawal study (SPIRIT-P3) was conducted.
- Biologic treatment-naive PsA patients received open-label ixekizumab for 36 weeks.
- Patients achieving sustained MDA were randomized to ixekizumab withdrawal (placebo) or continued ixekizumab treatment until week 104.
Main Results:
- 158 patients achieved sustained MDA and were randomized.
- Disease relapse occurred significantly faster in the withdrawal group (median 22.3 weeks) compared to the continued treatment group (median not estimable; P < 0.0001).
- 96% of patients who relapsed after withdrawal regained MDA upon re-treatment with ixekizumab.
Conclusions:
- Continued ixekizumab therapy is superior to withdrawal for maintaining MDA in biologic-naive PsA patients.
- Re-treatment with ixekizumab effectively restores disease control following treatment interruption.
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