Key clinical point: ORAL Shift demonstrates safety and efficacy of tofacitinib modified-release 11 mg once daily (OD) plus methotrexate in a global population of patients with rheumatoid arthritis (RA).
Major finding: All efficacy outcomes improved from baseline to week 12 including Disease Activity Score in 28 joints, erythrocyte sedimentation rate (mean change [MC], −2.0), Clinical Disease Activity Index (CDAI; MC, −19.6), Simplified Disease Activity Index (MC, −20.3), and other patient-reported outcomes, which continued to improve through week 24. At week 24, 84.5% of patients achieved CDAI-defined low disease activity. Most adverse events were mild or moderate in severity and no deaths were reported.
Study details: ORAL Shift , a 48-week phase 3b/4 withdrawal study included patients with moderate to severe RA and an inadequate response to methotrexate who received open-label tofacitinib modified-release 11 mg OD and methotrexate.
Disclosures: This study was sponsored by Pfizer Inc. Some of the authors declared receiving research support and honoraria and serving as consultant or on speaker’s bureau for various sources including Pfizer. Seven of the authors declared being employees and shareholders at Pfizer Inc.
Source: Cohen SB et al. RMD Open. 2021 Jun 7. doi: 10.1136/rmdopen-2021-001673.