Background/Purpose: Patients with psoriatic arthritis (PsA) who experience anti-TNF failure and switch to another TNF inhibitor as second- or third-line therapy typically show poorer responses compared to those receiving first-line anti-TNF treatment.¹ In this post-hoc analysis, we assessed baseline characteristics and long-term efficacy outcomes with upadacitinib (UPA) in the subgroup of patients with any prior anti-TNF exposure compared to the overall population within the SELECT-PsA 2 study, as well as explored efficacy by number of prior anti-TNF therapies.

Methods: In SELECT-PsA 2 (a double-blind, randomized controlled phase 3 trial), patients with active PsA and inadequate response or intolerance to ≥1 biologic DMARD were treated with UPA 15 mg or 30 mg once daily or placebo (PBO) for 24 wks.² Patients who had previous exposure to any JAK inhibitor were excluded. Stable background treatment with ≤2 non-biologic DMARDs was permitted but not required. Only data from patients initially randomized to UPA 15 mg are included here. This analysis determined the proportion of patients achieving ACR20/50/70, PASI90, resolution of dactylitis or enthesitis, and Minimal Disease Activity (MDA) up to wk 104 in both the overall study population and in the subgroup of patients with prior anti-TNF exposure (stratified by any exposure to TNF inhibitors and by number of prior anti-TNF treatments). NRI was used for all binary endpoints.

Results: Among patients randomized to UPA 15 mg (n = 211) in SELECT-PsA 2, 161 had prior exposure to any anti-TNF therapy. Baseline demographics and disease characteristics, including age, sex, years since PsA diagnosis, and use of background PsA therapies, were similar between the subgroup with anti-TNF exposure (Table) and the overall study population as reported previously.² Most patients in the anti-TNF exposure subset received 1 prior TNF inhibitor (57%), while 26% previously received 2 anti-TNFs and 17% previously received ≥3 anti-TNFs; 19% of patients were anti-TNF intolerant. At baseline, 50% and 11% of patients in the subgroup received concomitant non-biologic DMARD(s) and/or corticosteroid therapy, respectively. Efficacy outcomes were generally consistent among patients in the overall study population and in the subset of patients with prior anti-TNF exposure (Figure 1). Across efficacy endpoints, UPA 15 mg treatment also led to similar responses in patients with prior exposure to 1, 2, or ≥3 anti-TNF therapies (Figure 2). Given the limited sample sizes for the subset of patients with ≥3 prior anti-TNFs, however, those results should be interpreted with caution, but it is nonetheless noteworthy that this more refractory population demonstrated such favorable responses.

Conclusion: The prior anti-TNF exposure subgroup receiving UPA 15 mg demonstrated consistent efficacy in treating PsA (including joint-related symptoms, psoriasis, dactylitis, enthesitis, and comprehensive disease control as assessed by MDA) compared to the overall population in SELECT-PsA 2, regardless to the number of prior anti-TNF therapies.

References
1. Costa L, et al. Drugs R D 2017;17:509–22.
2. Mease PJ, et al. Ann Rheum Dis. 2021;80:312–20.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-of-upadacitinib-in-patients-with-psoriatic-arthritis-and-prior-exposure-to-anti-tnf-therapy-in-the-select-psa-2-trial-through-2-years/