SELECT-PsA 2: Upadacitinib maintains efficacy against PsA at 1 year
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Upadacitinib maintains its efficacy over 56 weeks in patients with psoriatic arthritis who had a prior inadequate response to at least one biologic disease-modifying antirheumatic drug, according to data presented at the EULAR 2021 Virtual Congress.
The findings come from the SELECT-PsA 2 study. Previous 24-week results from the study suggested upadacitinib (Rinvoq, AbbVie) efficacy in participants with PsA and an inadequate response to at least one biologic DMARD, with a safety profile that is consistent with what researchers observed in patients with rheumatoid arthritis.
“Many patients with PsA do not adequately respond to current therapies, highlighting an unmet need for additional treatments that can effectively control disease activity,” Philip J. Mease, MD, of Swedish Medical Center/Providence St. Joseph Health and the University of Washington, in Seattle, said in a poster session at the virtual meeting. “Upadacitinib is an oral JAK inhibitor that has been recently approved in Europe for the treatment of moderate-to-severe PsA. During the 24-week, placebo-controlled period of SELECT-PsA 2, [upadacitinib] demonstrated efficacy and acceptable safety in patients who have had an inadequate response or intolerance to at least one biologic DMARD.”
In the SELECT-PsA 2 study, Mease and colleagues randomly assigned 641 participants with PsA, who previously demonstrated an inadequate response to at least one biologic DMARD, to blinded treatment with either 15 mg or 30 mg of upadacitinib once daily or a placebo. To analyze the 56-week efficacy and safety of the drug in this population, the researchers switched all participants in the placebo group to either 15 mg or 30 mg of upadacitinib starting at week 24.
Efficacy endpoints included the proportion of participants who achieved 20%, 50% and 70% improvement in the ACR20/50/70 criteria, as well as 75%, 90% and 100% improvement in the Psoriasis Area and Severity Index (PASI75/90/100). Other efficacy endpoints were the resolution of dactylitis and enthesitis, and minimal disease activity (MDA). The researchers also summarized treatment-emergent adverse events, defined as those occurring while the participants were receiving upadacitinib or, for those who discontinued, 30 days or less after the last dose.
Among the randomized participants, 74.7% completed all 56 weeks of treatment.
According to the researchers, clinical improvements — based on the proportion of patients achieving ACR20/50/70, PASI75/90/100, minimal disease activity and the resolution of dactylitis and enthesitis — were “generally maintained” through 56 weeks of receiving upadacitinib. Week 56 results for participants who switched from placebo to the study drug at week 24 demonstrated a similar trajectory to those for patients who were initially randomized to upadacitinib. Overall, improvements noted with the 15mg dose of upadacitinib were similar to or approached those seen with the 30 mg dose through 56 weeks.
Regarding safety, the researchers observed dose-dependent increases for exposure-adjusted event rates of serious infections, herpes zoster, hepatic disorders, hematologic lab-related adverse events and creatine phosphokinase elevations, but not for exposure-adjusted incidence rates of major adverse cardiovascular events, venous thromboembolic events or malignancies. Rates of treatment-emergent adverse events were generally lower with the 15 mg dose of upadacitinib than with the higher dose.
“The overall study is important because it shows consistent effect over time and the effects in each clinical domain of PsA are robust, including skin,” Mease told Healio Rheumatology, “which for some reason appears to be a better response than other JAKs in that domain.”
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Mease PJ. Upadacitinib in patients with psoriatic arthritis refractory to biologic disease-modifying antirheumatic drugs: 56-week data from the phase 3 SELECT-PsA 2 study. Presented at: EULAR 2021 Virtual Congress; June 2-5, 2021 (virtual meeting).
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