Upadacitinib impactful vs. placebo in psoriatic arthritis with axial involvement
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Key takeaways:
- Upadacitinib 15 mg is superior to placebo for psoriatic arthritis with axial involvement.
- Efficacy and safety results were similar in all analyzed cohorts.
Patients with psoriatic arthritis and axial involvement experienced greater improvement when treated with upadacitinib 15 mg compared with placebo and adalimumab, according to data published in Arthritis Research & Therapy.
“Registry data suggest that PsA patients with axial involvement had higher disease activity and greater impairment in quality of life compared to PsA patients without axial involvement,” Xenofon Baraliakos, MD, of Ruhr-University Bochum, in Germany, and colleagues wrote. “Furthermore, axial involvement in PsA responds differently to certain treatments compared to peripheral PsA.”
To investigate the effectiveness and safety of upadacitinib (Rinvoq, AbbVie) in patients who demonstrate PsA with axial involvement, Baraliakos and colleagues conducted a post-hoc analysis of the SELECT-PsA 1 and SELECT-PsA 2 trials. Patients were eligible for inclusion in both trials if they were aged 18 years or older and had received a diagnosis of PsA. Additionally, patients were required to have a poor response or intolerance to one or more non-biologic disease-modifying antirheumatic drug, or one or more biologic DMARD.
Patients in both trials were randomized to receive upadacitinib 15 mg or 30 mg, placebo or adalimumab (Humira, AbbVie) 40 mg. Axial involvement was determined via investigator assessment. Efficacy outcomes were evaluated at weeks 12, 24 and 56 in both studies. These included change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores, modified BASDAI scores and the Ankylosing Spondylitis Disease Activity Score. In addition to efficacy outcomes, the researchers summarized safety data from both studies through 56 weeks.
Overall, 290 (22.6%) of patients in SELECT-PsA 1, and 121 (28.6%) patients in SELECT-PsA 2, demonstrated axial involvement according to investigator opinion and patient-reported outcome measures. According to the researchers, a greater proportion of patients SELECT-PsA 1 receiving upadacitinib 15 mg (60.4%) achieved BASDAI50, compared with those who received placebo (29.3%), at week 24. SELECT-PsA 2 produced similar results. In addition, the rates of treatment-emergent adverse events were similar in both groups and studies, the researchers wrote.
“Irrespective of the predefined assessment for axial involvement applied (investigator judgement alone or both investigator judgement and PRO-based criteria), patients with active PsA and axial involvement demonstrated improvements in their axial symptoms with upadacitinib 15 mg, often with greater numerical responses versus adalimumab, which were maintained over long-term follow-up (56 weeks) in two phase 3 studies,” Baraliakos and colleagues wrote. “Safety results for upadacitinib 15 mg were generally comparable between patients with or without axial involvement.”
Perspective
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Without agreed upon classification or diagnostic criteria for axial involvement in psoriatic arthritis, and no consensus on treatment paradigms, management of axial PsA can be challenging. The analysis provided by Baraliakos and colleagues indicates that the prevalence rates for patients with PsA who have axial involvement ranges from 5% to 70%. This wide range indicates that properly identifying and treating these patients remains a relevant issue within rheumatology.
Axial involvement has been linked to higher reported disease activity scores, with worsening impact on quality of life, further highlighting the importance of safe and effective treatment options. The analysis indicates that upadacitinib 15 mg daily has demonstrated reduced disease activity and axial inflammation, as well as improved function, among patients vs. adalimumab, providing additional reassurance of the efficacy of JAK inhibitors to treat axial disease.
Without significant safety differences between patients with and without axial involvement, upadacitinib provides another treatment option for patients with this challenging diagnosis.
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