Tsutomu Takeuchi1, Maureen Rischmueller2, Ricardo Blanco3, Ricardo M Xavier4, Yukitaka Ueki5, Tatsuya Atsumi6, Su Chen7, Alan Friedman7, Aileen L Pangan7, Vibeke Strand8, Ronald F van Vollenhoven9. 1. Keio University School of Medicine, Tokyo, Japan. 2. The Queen Elizabeth Hospital and University of Adelaide, Adelaide, Australia. 3. Hospital Universitario Marques de Valdecilla, Cantabria, Spain. 4. Universidade Federal do Rio Grande do Sul, Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil. 5. Rheumatic and Collagen Disease Center, Sasebo Chuo Hospital, Sasebo, Nagasaki, Japan. 6. Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Hokkaido University, Sapporo, Japan. 7. AbbVie Inc., North Chicago, IL, United States. 8. Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, United States. 9. Amsterdam University Medical Centers, Amsterdam, The Netherlands.
Abstract
OBJECTIVE: To assess upadacitinib monotherapy versus methotrexate (MTX) in MTX-naïve Japanese patients with rheumatoid arthritis (RA) from the Phase 3 SELECT-EARLY study. METHODS: Japanese patients were randomized 2:1:1:1 to upadacitinib 7.5, 15, or 30 mg daily or MTX 7.5 mg/week (titrated to ≤15 mg/week). Efficacy endpoints included the proportion of patients reporting 20% improvement in American College of Rheumatology criteria (ACR20) at week 12 and change from baseline in modified Total Sharp Score (mTSS) at week 24. Other efficacy outcomes were also assessed at weeks 12 and/or 24. Safety was assessed over 24 weeks. RESULTS: Of 138 Japanese patients enrolled, significantly more patients treated with upadacitinib 7.5 and 15 mg, but not 30 mg, reported ACR20 responses versus MTX at week 12. Significantly smaller changes from baseline in mTSS were observed with upadacitinib 15 and 30 mg, but not 7.5 mg, versus MTX at week 24. Upadacitinib demonstrated an acceptable safety profile; herpes zoster occurred in 3.6%, 7.4%, and 7.1% of patients treated with upadacitinib 7.5, 15, and 30 mg, respectively. CONCLUSION: Similar to the global study population, upadacitinib demonstrated clinical efficacy superior to placebo in the Japanese subpopulation. Among upadacitinib-treated patients, herpes zoster was least common with 7.5 mg.
OBJECTIVE: To assess upadacitinib monotherapy versus methotrexate (MTX) in MTX-naïve Japanese patients with rheumatoid arthritis (RA) from the Phase 3 SELECT-EARLY study. METHODS: Japanese patients were randomized 2:1:1:1 to upadacitinib 7.5, 15, or 30 mg daily or MTX 7.5 mg/week (titrated to ≤15 mg/week). Efficacy endpoints included the proportion of patients reporting 20% improvement in American College of Rheumatology criteria (ACR20) at week 12 and change from baseline in modified Total Sharp Score (mTSS) at week 24. Other efficacy outcomes were also assessed at weeks 12 and/or 24. Safety was assessed over 24 weeks. RESULTS: Of 138 Japanese patients enrolled, significantly more patients treated with upadacitinib 7.5 and 15 mg, but not 30 mg, reported ACR20 responses versus MTX at week 12. Significantly smaller changes from baseline in mTSS were observed with upadacitinib 15 and 30 mg, but not 7.5 mg, versus MTX at week 24. Upadacitinib demonstrated an acceptable safety profile; herpes zoster occurred in 3.6%, 7.4%, and 7.1% of patients treated with upadacitinib 7.5, 15, and 30 mg, respectively. CONCLUSION: Similar to the global study population, upadacitinib demonstrated clinical efficacy superior to placebo in the Japanese subpopulation. Among upadacitinib-treated patients, herpes zoster was least common with 7.5 mg.
Authors: Philip G Conaghan; Eduardo Mysler; Yoshiya Tanaka; Barbara Da Silva-Tillmann; Tim Shaw; John Liu; Ryan Ferguson; Jeffrey V Enejosa; Stanley Cohen; Peter Nash; William Rigby; Gerd Burmester Journal: Drug Saf Date: 2021-02-02 Impact factor: 5.606