Upadacitinib improves psoriasis, physical function, pain, radiographic progression in PsA
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Among patients with psoriatic arthritis, daily upadacitinib doses of either 15 or 30 mg improved musculoskeletal symptoms, psoriasis, physical function, pain, fatigue and radiographic progression, according to a speaker at ACR Convergence.
“Upadacitinib is an oral reversible JAK inhibitor with relative selectivity for JAK1,” Iain McInnes, MD, president of EULAR and director of the Institute of Infection, Immunity and Inflammation at the University of Glasgow, in Scotland, told attendees at the virtual meeting. “Upadacitinib 15 mg is approved for people with rheumatoid arthritis.”
To analyze the efficacy and safety of upadacaitinib (Rinvoq, AbbVie) compared with placebo and adalimumab (Humira, AbbVie), among patients with PsA with a previous insufficient response or intolerance to at least one non-biologic DMARD, McInnes and colleagues conducted a double-blind, randomized, controlled phase 3 trial. A total of 1,705 participants were randomized to receive either 15 mg upadacitinib daily, 30 mg upadacitinib daily, 40 mg of adalimumab every other week or placebo.
The primary endpoint was the proportion of patients in the upadacitinib group who achieved an ACR20 response compared with those who received placebo at week 12. Multiplicity controlled secondary endpoints for each upadacitinib dosage group, compared with placebo, included change in HAQ-DI, FACIT-F and SF-36 PCS at week 12; static Investigator Global Assessment of Psoriasis of 0 or 1, PASI75 and change in self-reported psoriasis symptoms at week 16; and change in modified Sharp/van der Heijde Score (mTSS), the proportion of patients achieving minimal disease activity and the resolution of enthesitis and dactylitis at week 24.
The multiplicity-controlled analysis for each upadacitinib dosage group also included non-inferiority and superiority compared with adalimumab for ACR20 response, and superiority for HAQ-DI and patients’ pain assessment at week 12. ACR50/70 response at week 12 and ACR20 response at week 2 were also secondary endpoints. The researchers reported adverse events through week 24 for participants who received at least one dose of the study drug.
According to the researchers, ACR20 response rates at week 12 were 70.6% in the 15 mg upadacitinib group and 78.5% in the 30 mg upadacitinib group, compared with 36.2% among those who received placebo (P < .001) and 65% in those treated with adalimumab (P < .001). In addition, a greater proportion of participants achieved ACR50/70 responses with either upadacitinib group compared with placebo, and with 30 mg of compared with adalimumab.
The researchers also observed improvements among patients in both upadacitinib groups compared with placebo for all multiplicity controlled secondary endpoints, as well as compared with adalimumab for HAQ-DI, and upadacitinib 30 mg compared with adalimumab for improved pain. Changes in mTSS at week 24 were 0.25 for the placebo group, –0.04 for the 15 mg upadacitinib group, 0.03 for the 30 mg upadacitinib group, and 0.01 for those treated with adalimumab (P < .001).
The rates of adverse and serious adverse events, including serious infections, were similar across the placebo, adalimumab and 15 mg upadacitinib groups, but higher among those treated with 30 mg of upadacitinib. Rates of herpes zoster were similar across the placebo and both upadacitinib groups. No major adverse cardiovascular events were reported with either upadacitinib group. The placebo and 15 mg upadacitinib arms each reported one malignancy, whereas the 30 mg upadacitinib and adalimumab groups each reported three malignancies.
Venous thromboembolism was reported in one patient in the placebo arm, one participant in the 30 mg upadacitinib group and in two patients treated with adalimumab. One death occurred in the placebo arm.
“Upadacitinib 15 mg and 30 mg demonstrate superior efficacy compared to placebo in treating psoriatic arthritis symptoms and signs in patients’ refractory to prior non-biologic DMARD therapy,” McInnes said. “In terms of ACR20 response at week 12, both doses achieved non-inferiority versus adalimumab, and in fact upadacitinib 30 mg achieved superiority compared to adalimumab, and the efficacy effect was observed as early as week 2.”
“The safety findings were consistent with the known safety profile observed in rheumatoid arthritis,” he added. “No new safety risks were identified. It also appears to demonstrate inhibition of radiographic progression, which is very gratifying in this group of patients.”
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McInnes I. Abstract 2026. Presented at: ACR Convergence 2020; November 5-9, 2020 (virtual meeting).
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