Safety and Efficacy of Upadacitinib (UPA) in Japanese Patients with Rheumatoid Arthritis (RA) and Inadequate Response to Conventional Synthetic DMARDs: Results Through 5 Years from the SELECT-SUNRISE Study

Hideto Kameda¹, Tsutomu Takeuchi², Kunihiro Yamaoka³, Motohiro Oribe⁴, Mitsuhiro Kawano⁵, Masayuki Yokoyama⁶, Yuko Konishi⁶, Sumi Chonan⁶, Sara Penn⁷, Heidi S Camp⁷ and Yoshiya Tanaka⁸, ¹Toho University, Tokyo, Japan, ²Department of Internal Medicine, Keio University, Tokyo, Tokyo, Japan, ³Kitasato University School of Medicine, Kanagawa, Japan, ⁴Oribe Clinic of Rheumatism and Medicine, Oita, Japan, ⁵Kanazawa Medical University, Ishikawa, Japan, ⁶AbbVie GK, Tokyo, Japan, ⁷AbbVie, North Chicago, IL, ⁸Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan

Meeting: ACR Convergence 2024

Keywords: clinical trial, Disease-Modifying Antirheumatic Drugs (Dmards), Randomized Trial, rheumatoid arthritis

Session Information

Date: Sunday, November 17, 2024

Title: RA – Treatment Poster II

Session Type: Poster Session B

Session Time: 10:30AM-12:30PM

Background/Purpose: To evaluate the efficacy and safety of UPA in Japanese RA patients (pts) up to 5 yrs in a long term extension (LTE)
of SELECT-SUNRISE.

Methods: Pts who completed the wk12 double-blind period proceeded to a blinded LTE to continue UPA 7.5mg, 15mg or 30mg QD while pts randomized to placebo were switched to 7.5mg, 15mg or 30mg QD. UPA 30mg QD were switched to 15mg QD prior to marketing approval.

Results: Of the 197pts, 187 (95%) completed wk12 and entered LTE. During the LTE, 66 (33.5%) pts discontinued study drug: due to adverse events (AEs, 21.3%), withdrawal of consent (6.1%), loss to follow-up (0.5%), lack of efficacy (0.5%), COVID-19 infection or logistic restrictions (0.5% respectively) or other reasons (4.1%). Clinical outcomes improved and maintained through wk260 as demonstrated by 57%, 45% and 56% achieving CDAI remission with UPA7.5, 15 and 30mg (AO). The incidences rate of serious AEs (n/100 PYS) in UPA 7.5 mg, 15 mg and 30 mg were 7.8, 14.0 and 14.2 and serious infections for 3.5, 4.9, 8.8; HZ for 5.9, 9.8, 11.8; MACE for 0.8, 0.4, 0.5; VTE for 0, 0, 0.5; malignancy for 0.4, 1.2, 0.5, respectively.

Conclusion: Efficacy of UPA was maintained through 5 yrs. The safety profile was consistent with earlier time points and with an integrated phase3 safety analysis of UPA in RA.

Disclosures: H. Kameda: AbbVie GK, 2, 5, 6, Asahi-Kasei, 2, 5, 6, Boehringer Ingelheim GmbH, 2, 5, 6, Bristol-Myers Squibb, 2, 6, Chugai, 2, 5, 6, Eisai, 5, Eli Lilly Japan K.K., 2, 6, Janssen K.K., 2, 6, Mitsubishi-Tanabe, 2, 5, 6, Novartis, 2, 6, Pfizer Japan, 2, 6, Sanofi K.K., 2, 6, Taisho, 5, UCB Japan, 2, 6; T. Takeuchi: AbbVie, 4, 6, Astellas, 2, 6, Eisai, 4, 6, Eli Lilly Japan, 2, 6, Gilead, 2, 6, Pfizer Japan, 6; K. Yamaoka: Abbvie GK, 6, Actellion Pharma, 6, Asahi-Kasei, 6, Astellas, 6, AYUMI, 6, Boehringer-Ingelheim Japan, 6, Bristol Myers Squibb, 6, Chugai, 6, Daiichi-Sankyo, 6, Eisai Pharma, 6, Eli Lilly, 6, Gilead, 6, GlaxoSmithKlein, 6, Hisamitsu Pharna, 6, Janssen, 6, Japan Tobacco Inc., 6, MDS KK, 6, Mitsubishi-Tanabe, 6, Nippon Kayaku, 6, Nippon Shinyaku, 6, Ono Pharma, 6, Otsuka Pharma, 6, Pfizer, 6, Sanofi K.K., 6, Takeda, 6; M. Oribe: None; M. Kawano: None; M. Yokoyama: AbbVie, 3; Y. Konishi: AbbVie, 3; S. Chonan: AbbVie, 3; S. Penn: AbbVie, 3; H. Camp: AbbVie, 3; Y. Tanaka: AbbVie, 6, Asahi-kasei, 6, Astellas, 6, AstraZeneca, 6, Boehringer Ingelheim, 5, 6, Chugai, 5, 6, Daiichi Sankyo, 6, Eisai, 6, Gilead, 6, GSK, 6, Lilly, 6, Pfizer, 6, Taisho, 5, 6, UCB, 6.

To cite this abstract in AMA style:

Kameda H, Takeuchi T, Yamaoka K, Oribe M, Kawano M, Yokoyama M, Konishi Y, Chonan S, Penn S, Camp H, Tanaka Y. Safety and Efficacy of Upadacitinib (UPA) in Japanese Patients with Rheumatoid Arthritis (RA) and Inadequate Response to Conventional Synthetic DMARDs: Results Through 5 Years from the SELECT-SUNRISE Study [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/safety-and-efficacy-of-upadacitinib-upa-in-japanese-patients-with-rheumatoid-arthritis-ra-and-inadequate-response-to-conventional-synthetic-dmards-results-through-5-years-from-the-select-sunrise/. Accessed .

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