medwireNews: Treatment with upadacitinib is associated with improvements in various patient-reported outcomes (PROs) among people with rheumatoid arthritis (RA), suggest post-hoc analyses of the SELECT-NEXT and SELECT-BEYOND trials.
As reported previously by medwireNews, the main results from SELECT-NEXT demonstrated the efficacy of once daily upadacitinib 15 mg or 30 mg versus placebo in patients with an inadequate response to conventional synthetic (cs)DMARDs, while SELECT-BEYOND demonstrated efficacy of the same doses of the Janus kinase (JAK)1 inhibitor in patients with an inadequate response to biologic DMARDs. Participants received concomitant treatment with csDMARDs in both studies.
In the PRO analysis for SELECT-NEXT, Namita Tundia (AbbVie Inc., North Chicago, Illinois, USA) demonstrated that the 221 patients treated with upadacitinib 15 mg/day and the 219 given the 30 mg/day dose experienced significantly greater improvements in patient-reported disease activity, pain, fatigue, physical function, health-related quality of life (QoL), and morning stiffness from baseline to week 12 than the 221 participants given placebo.
“Assessing the effect of upadacitinib on [these outcomes] is important because [they] directly impact [health-related QoL] by reducing patients’ ability to perform daily activities and providing barriers to maintaining employment,” explain Tundia and colleagues.
Indeed, participants in the upadacitinib groups also experienced significantly greater improvements in work instability scores – a measure of mismatch between an individual’s functional capabilities and job demands because of RA – than those in the placebo arm.
The investigators report that a significantly higher proportion of patients treated with the JAK1 inhibitor versus placebo reported improvements greater than the prespecified minimal clinically important difference (MCID) for the majority of PROs, and the number needed to treat (NNT) to achieve clinically meaningful improvements ranged from four to eight patients across most measures.
NNTs of 10 or lower “are generally considered favourable and demonstrate the value of upadacitinib treatment for csDMARD-[inadequate responder] patients with RA,” say the researchers, noting that “[t]here appears to be little difference in the treatment responses between the upadacitinib 15-mg and 30-mg doses, consistent with the reported primary efficacy results.”
In accordance with these findings, Tundia and colleagues demonstrated similar results in their PRO analysis of the SELECT-BEYOND trial. Among patients with an inadequate response to biologic DMARDs, those in the upadacitinib 15 mg/day (n=164) and 30 mg/day (n=165) groups reported significant improvements in disease activity, pain, physical function, and morning stiffness from baseline to week 12 relative to those given placebo (n=169).
They note that all these improvements were greater than the MCID, and that the NNT ranged from four to seven patients for most outcomes.
The team concludes: “These clinically relevant improvements in PROs are consistent with the positive efficacy findings reported in this […] population and suggest that upadacitinib may be an important treatment option in patients with active and refractory RA.”
The PRO analyses for both trials are published in Arthritis Research & Therapy.
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Arthritis Res Ther 2019; 21: 263
Arthritis Res Ther 2019; 21: 272