Key clinical point: The disease activity metrics of rheumatoid arthritis (RA) improved significantly with upadacitinib plus elsubrutinib (ABBV-599) vs placebo in patients with inadequate response or intolerance to biologics, with effects likely driven by upadacitinib and not elsubrutinib.
Major finding: At week 12, compared with placebo, the change in Disease Activity Score of 28 joints with C-reactive protein was significantly higher with ABBV-599 (least squares mean difference [LSMD] −1.44) and upadacitinib (LSMD −1.75; both P < .0001) but not with elsubrutinib. The incidence of treatment-emergent adverse events was similar for ABBV-599 and placebo.
Study details: This was a phase 2 trial including 242 patients with RA and inadequate response/intolerance to biologics who were randomly assigned to receive ABBV-599, elsubrutinib (60, 20, or 5 mg), upadacitinib, or placebo for 12 weeks.
Disclosures: This study was funded by AbbVie. R Fleischmann and several authors reported receiving grant support or honorarium for consultancy from various sources, including AbbVie . Six authors declared being full-time current or former employees or holding stocks or stock options at AbbVie.
Source: Fleischmann R et al. Safety and efficacy of elsubrutinib or upadacitinib alone or in combination (ABBV-599) in patients with rheumatoid arthritis and inadequate response or intolerance to biological therapies: A multicentre, double-blind, randomised, controlled, phase 2 trial. Lancet Rheumatol. 2022 (Apr 27). Doi: 10.1016/S2665-9913(22)00092-3