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In psoriatic arthritis people having inadequate response or intolerance to non-biological therapy, 30 mg and 15 mg upadacitinib demonstrated superiority to placebo and non-inferiority to adalimumab regarding ≥20% improvement in the American College of Rheumatology (ACR) criteria at twelve weeks in phase III SELECT-PsA 1 study.
The efficacy responses across
various domains of psoriatic arthritis were maintained with 15 mg and 30 mg
upadacitinib over 56 weeks and were numerically higher when compared to
adalimumab.
In psoriatic arthritis people having inadequate response or intolerance to non-biological therapy, 30 mg and 15 mg upadacitinib demonstrated superiority to placebo and non-inferiority to adalimumab regarding ≥20% improvement in the American College of Rheumatology (ACR) criteria at twelve weeks in phase III SELECT-PsA 1 study.
This study reported efficacy and
safety of upadacitinib vs. adalimumab over fifty-six weeks from SELECT-PsA 1.
The recruited participants received 15 mg or 30 mg upadacitinib once daily, 40 mg adalimumab every other week for fifty-six weeks or placebo through week twenty-four switched thereafter to 15mg or 30mg upadacitinib until week fifty-six.
The
efficacy outcomes incorporated the percentage of people attaining: (i)
≥75%/90%/100% improvement in Psoriasis Area and Severity Index (PASI75/90/100),
(ii) minimal
disease activity and alteration from baseline in modified total Sharp/van der
Heijde Score, and (iii) ≥20%/50%/70% improvement in ACR criteria (ACR20/50/70).
The treatment-emergent adverse events per 100 patient-years were summarized.
Consistent with results through week twenty-four, the minimal disease activity responses, ACR20/50/70, and PASI75/90/100 were maintained with upadacitinib through week fifty-six and were usually numerically greater in comparison with adalimumab. Suppression of radiographic advancement was also maintained.
Participants who switched from
placebo to upadacitinib showed comparable improvements at week fifty-six as
participants were originally randomized to upadacitinib. The rates of severe
adverse events were 12.3 events/100 patient-years with 30 mg upadacitinib and
9.1 events/100 patient-years with 15 mg upadacitinib. Notably, 2 deaths were
noted in both 30 mg and 15 mg upadacitinib cohorts. There were no novel safety
findings noted with longer term upadacitinib exposure.
The 56-week efficacy data across
all the key domains of psoriatic arthritis favor the benefits of continued
upadacitinib treatment in psoriatic arthritis people. Safety at week fifty-six
was comparable to findings through week twenty-four.
RMD Open
Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study
Iain B McInnes et al.
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