medwireNews: Upadacitinib has similar efficacy and safety profiles in patients with psoriatic arthritis (PsA) regardless of whether the drug is administered as monotherapy or as an add-on treatment to conventional DMARDs, suggests a pooled analysis of the SELECT-PsA 1 and SELECT-PsA 2 trials.
“This supports the use of upadacitinib with or without [nonbiologic] DMARDs in PsA and suggests that upadacitinib monotherapy may be a useful treatment option in patients with contraindications to [methotrexate] or those who are unable to tolerate higher doses,” say Peter Nash (Griffith University, Brisbane, Queensland, Australia) and study co-authors.
The team evaluated data from 1916 people with active PsA who took part in either SELECT-PsA 1 (patients with prior exposure to to at least one nonbiologic DMARD) or SELECT-PsA 2 (patients with prior exposure to at least one biologic agent) and were treated with upadacitinib 15 mg or 30 mg once daily. In total, 574 participants received upadacitinib monotherapy, while 1342 received the Janus kinase (JAK)-1 selective inhibitor in combination with a conventional DMARD, most commonly methotrexate (n=1036).
As reported in Rheumatology, placebo-subtracted ACR20 response rates at week 12 were a comparable 33.7% for patients given upadacitinib 15 mg monotherapy and 34.0% for those given upadacitinib 15 mg alongside any conventional DMARD. The corresponding rates for people given the higher dose of the JAK inhibitor were 45.7% and 39.6%.
In addition, there was consistency between the monotherapy and combination therapy groups for placebo-subtracted ACR50 and ACR70 response rates at week 12, as well as rates of minimal disease activity and resolution of enthesitis and dactylitis at week 24, say Nash et al.
They add that the findings were similar when the analysis was restricted to patients receiving methotrexate as their conventional DMARD.
In the safety analysis, the researchers found that upadacitinib was well tolerated when used as monotherapy or in combination with a DMARD, “with the majority of [adverse events] seen at comparable frequencies” across the groups.
Overall, the findings from the pooled analysis point to “generally consistent” efficacy and safety of upadacitinib when administered as monotherapy or combination therapy, in accordance with previous studies of tumor necrosis factor inhibitors and ixekizumab, say Nash et al.
They note that “all patients who were taking a [nonbiologic] DMARD at study entry met inclusion criteria related to active disease,” and therefore “these data permit assessment of the safety and efficacy of treatment with upadacitinib added to stable background therapy.”
However, they stress that the study results “are not able to inform the benefit or risk of starting both drugs simultaneously, or adding a [nonbiologic] DMARD to existing upadacitinib therapy.”
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