Takeaway
- In biologic-naive patients with psoriatic arthritis (PsA), continued ixekizumab (IXE) therapy was superior to IXE withdrawal in maintaining minimum disease activity (MDA).
- A vast majority of patients who lost MDA after IXE withdrawal regained MDA with IXE re-treatment.
Why this matters
- Findings indicate that continuous IXE treatment is optimal for maintaining MDA; however, patients can regain MDA after re-treatment with IXE in case of treatment interruption.
Study design
- SPIRIT-P3 was a multicentre, randomised, double-blind withdrawal study of 394 biologic-naive patients with PsA who received open-label IXE (160 mg at week 0, 80 mg every 2 weeks) for 36 weeks.
- Between weeks 36 and 64, 158 patients who achieved sustained MDA (>3 months) were randomised (1:1) to continue on 80-mg IXE every 2 weeks or placebo until week 104.
- Primary efficacy outcome: time to relapse (loss of MDA).
- Funding: Eli Lilly and Company.
Key results
- Patients relapsed more rapidly with IXE withdrawal (median, 22.3 weeks [95% CI, 16.1-28.3]) vs continued IXE treatment (median was not estimable because <50% of patients had relapsed by the end of study period, P<.0001).
- The cumulative relapse rate from week 24 to week 104 was significantly higher for the withdrawal group vs continued treatment group (85% vs 38%; P<.0001).
- The median time to re-achieving MDA on retreatment was 4.1 weeks (95% CI, 4.1-4.3); 64 (95.5%) of 67 patients who relapsed with treatment withdrawal re-achieved MDA on retreatment.
- Overall, safety data were consistent with previous IXE PsA studies with no unexpected safety signals.
Limitations
- Approved dosing regimen for PsA in the US and Europe is IXE every 4 weeks, whereas the dose used in this study was every 2 weeks.
This clinical summary originally appeared on Univadis, part of the Medscape Professional Network.
