Peterfy CG, Strand V, Friedman A, et al. - Findings demonstrate the effectiveness of upadacitinib monotherapy or in combination with background methotrexate in inhibiting the progression of structural joint damage through week 48 in methotrexate-naïve and methotrexate-inadequate responders (IR) patients with rheumatoid arthritis (RA).

• In two phase 3 randomized-controlled trials, methotrexate–naïve patients received upadacitinib 15 or 30 mg once daily (QD) or methotrexate monotherapy (SELECT–EARLY, n = 945), while methotrexate IR received upadacitinib 15 mg QD or adalimumab 40 mg every other week or placebo added to background methotrexate (SELECT–COMPARE, n = 1629).

• Relative to baseline, mean changes in modified Total Sharp Score (mTSS) up to week 48 were 0.03 for upadacitinib 15 mg, 0.14 for upadacitinib 30 mg, and 1.00 for methotrexate, in cases naïve or with limited exposure to methotrexate (SELECT-EARLY).

• In SELECT-COMPARE, the mean alteration from baseline in mTSS was significantly decreased in the upadacitinib 15 mg plus methotrexate group vs placebo plus methotrexate (0.28 vs 1.73); mean alteration from baseline in the adalimumab plus methotrexate group was 0.39.