The results of two randomized control trials that assessed the efficacy of two medications in PsA patients who failed TNF inhibitors were reported Thursday at EULAR:
The SPIRIT-2 study (#OP0201) assessed the efficacy of ixekizumab (IXE), an IL-17A inhibitor, compared with placebo after 24 weeks. Patients with inadequate response to 1 or 2 TNFi’s were randomized to IXE 80 mg every 2 weeks or 4 weeks. At week 24, a significantly higher proportion of IXE vs. placebo treated patients achieved ACR20 (53%, 48% vs. 20%; Q4W, Q2W, placebo, respectively). Secondary outcomes including ACR50, ACR70, minimal disease activity state and improvement in HAQ-DI were also more frequent in both IXE groups. In addition, completed resolution of dactylitis was more frequent in IXE-treated patients. While there was improvement in enthesitis scores, there was no significant difference in complete resolution of enthesitis across the treatment arms. Finally, the improvement in skin psoriasis was significantly higher in IXE-treated patients compared with controls. No new safety signals were detected.
The OPAL BEYOND study assessed the efficacy of tofacitinib, an oral JAK inhibitor, in patients with PsA who had inadequate response to TNFi (#OP0202). Patients were randomized to tofacitinib 5 mg twice daily (BID), tofacitinib 10 mg BID or placebo. Ongoing treatment with 1 conventional synthetic DMARD was required. At 3 months, more patients in the tofacitinib groups achieved ACR20 (47%, 50% vs. 23%; 10 mg BID, 5 mg BID, placebo, respectively). Response was noted as early as week 2 and maintained throughout the study (6 months). Improvement in secondary outcomes such as ACR50, ACR70, HAQ-DI, enthesitis and dactylitis were also reported in the tofacitinib groups. Only a moderate improvement was noted in skin psoriasis in the high-dose tofacitinib group. No new safety risks were identified.
In summary, ixekizumab and tofacitinib may be considered as future treatment options in patients with PsA who failed TNF inhibitors.
Dr. Lihi Eder is an Assistant Professor of Medicine at the University of Toronto and Staff Rheumatologist and Director of the Psoriatic Arthritis Research Program at Women’s College Hospital. Dr. Eder is a Scientist at Women’s College Research Institute and associate member of the graduate faculty at the Institute of Medical Science.View Full Bio