Phase III SELECT-PsA 1 trial of Rinvoq in psoriatic arthritis published in NEJM.- AbbVie

AbbVie announced that the New England Journal of Medicine has published 24-week results from the Phase III SELECT-PsA 1 trial evaluating Rinvoq (upadacitinib, 15 mg and 30 mg) in adults with active psoriatic arthritis who had responded inadequately or were intolerant to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs). These data build on previously announced Phase III topline results showing that upadacitinib 15 mg and 30 mg met the primary endpoint of ACR20 response at week 12 versus placebo as well as key secondary endpoints. Efficacy results for ranked secondary endpoints not previously reported include: A significantly higher percentage of patients taking upadacitinib 15 mg and 30 mg (54 and 58 percent, respectively) achieved resolution of enthesitis (Leeds Enthesitis Index (LEI)=0) compared to those taking placebo (32 percent) at week 24 (p<0.001 for both doses); 47 percent of patients achieved resolution of enthesitis in the adalimumab group. patients taking upadacitinib 15 mg and 30 mg (6.3 and 7.1 mean change from baseline, respectively) saw an improvement in fatigue compared to patients taking placebo (2.8) at week 12 (p><0.001 for both doses), as measured by the functional assessment of chronic illness therapy-fatigue (facit-f) scale, which continued to improve through week 24; patients in the adalimumab group saw an improvement (5.7) at week 12. at week 16, significantly more patients achieved a score of 0 or 1 and at least a 2-point improvement in the static investigator global assessment of psoriasis (siga) with the 15 mg and 30 mg doses of upadacitinib (42 and 54 percent, respectively) versus placebo (11 percent, p><0.001 for both doses); 39 percent of patients in the adalimumab group. inhibition of radiographic progression, as measured by the modified total sharp van der heijde score (mtss) at week 24, was observed with both doses of upadacitinib (-0.04 for the 15 mg dose, p><0.001, and 0.03 for the 30 mg dose, p="0.007)," compared to placebo, which showed an increase of 0.25; 0.01 was observed in the adalimumab group. at week 24, 77 percent and 80 percent of patients taking 15 mg and 30 mg of upadacitinib, respectively, achieved resolution of dactylitis (leeds dactylitis index (ldi)="0)" compared to 40 percent of patients taking placebo (nominal p-values><0.001; comparison not multiplicity controlled); 74 percent of patients achieved resolution of dactylitis in the adalimumab group.see: "trial of upadacitinib and adalimumab for psoriatic arthritis." mcinnes i, et al. new england journal of medicine. 2021 april 1;384:1227-1239. doi: 10.1056 nejmoa2022516.>