Upadacitinib effective as monotherapy, in combination with non-biologics for PsA
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Upadacitinib demonstrates comparable efficacy and safety as monotherapy or in combination with non-biologic disease-modifying antirheumatic drugs in patients with psoriatic arthritis, according to data published in Rheumatology.
“PsA patients typically have issues with non-alcoholic fatty liver, metabolic syndrome, drug and alcohol excess so use of the anchor drug methotrexate can be problematic, including having to use sub-optimal methotrexate dosages when liver function tests are abnormal,” Peter Nash, MD, MBBS, FRACP, of Griffith University, in Brisbane, Australia, told Healio Rheumatology. “To maintain efficacy without requiring methotrexate or other conventional synthetic DMARDs is a big plus as demonstrated in this study.”
To examine the efficacy and safety of upadacitinib (Rinvoq, AbbVie) as monotherapy and in combination with non-biologic DMARDs in PsA, Nash and colleagues conducted a pooled subgroup analysis of data from the phase 3 SELECT-PsA 1 and SELECT-PsA 2 trials. In both trials, patients with active PsA, as well as active or prior psoriasis, were blindly randomized to receive upadacitinib 15 mg, upadacitinib 30 mg or placebo daily, or — in SELECT-PsA 1 only — adalimumab (Humira, AbbVie) for 24 weeks.
Participants in SELECT-PsA 1 had previous inadequate response or intolerance to at least one non-biologic DMARD, while those in SELECT-PsA 2 demonstrated inadequate response or intolerance to at least one biologic DMARD.
For this analysis, Nash and colleagues included 1,916 participants from both studies who received upadacitinib or placebo, either as monotherapy or in combination with two or fewer non-biologic DMARDs. Among the included patients, 574 received monotherapy while 1,342 were treated with combination therapy. Efficacy outcomes included American College of Rheumatology responses, Psoriasis Area and Severity Index (PASI) responses, minimal disease activity, and change from baseline and clinically meaningful improvements in the Health Assessment Questionnaire-Disability Index (HAQ-DI).
According to the researchers, placebo-subtracted treatment effects for ACR20 response at week 12 were 33.7% (95% CI, 24.4-43.1) and 34% (95% CI, 27.9-40.1) for upadacitinib 15mg monotherapy and combination therapy, respectively. Among those who received the the 30 mg formulation, ACR20 treatment effects were 45.7% (95% CI, 36.9-54.5) and 39.6% (95% CI, 33.7-45.5) for monotherapy and combination therapy, respectively. Treatment effects for other outcomes were comparable between monotherapy and combination therapy groups.
Meanwhile, the frequency of adverse events was generally similar between upadacitinib monotherapy and combination therapy groups. However, hepatic disorders and creatine phosphokinase elevation were more common among those who received combination therapy, compared with monotherapy.
“Upadacitinib showed comparable efficacy as monotherapy and in combination with non-biologic DMARDs in PsA,” Nash said. “The safety profile of upadacitinib was generally similar with monotherapy and combination therapy. Hepatic disorder events and creatine phosphokinase elevation were less common with monotherapy versus combination therapy.”
He added: “From the SELECT-PsA clinical trial program, efficacy can be maintained with added safety when upadacitinib 15 mg is used as monotherapy, when compared with combination therapy with methotrexate or other conventional synthetic DMARDs in active PsA.”
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