LAUSR

Baricitinib (BARI), an oral selective Janus kinase 1/2 inhibitor, has demonstrated efficacy in patients (pts) with rheumatoid arthritis (RA) for up to 3 years (yrs) in a long-term extension (LTE) study RA-BEYOND.1Disclose efficacy of BARI in csDMARD-IR pts in the completed LTE study (up to 7 yrs).In RA-BUILD, csDMARD-IR pts were randomized 1:1:1 to BARI 4 mg, 2 mg, or placebo (PBO). Completers to week (wk) 24 could enter the LTE and received BARI 4 or 2 mg. In RA-BEAM, MTX-IR pts were randomized 1:1:1 to BARI 4 mg, adalimumab (ADA) 40 mg, or PBO. Completers to wk 52 received BARI 4 mg in the LTE. Pts with no response could be rescued after wk 16 in both studies. Data were analysed by treatment assigned at baseline in originating studies as observed up to time of stepdown (if applicable), study discontinuation or completion, whichever occurred earlier. Efficacy response rates (RR) were assessed as proportions of pts with observed data up to yr 7 (wk 364) for low-disease activity (LDA) (SDAI ≤ 11, DAS28-hsCRP ≤ 3.2, CDAI ≤ 10), remission (REM) (SDAI ≤ 3.3, DAS28-hsCRP < 2.6, CDAI ≤ 2.8, Boolean), and physical function (HAQ-DI ≤ 0.5). No formal statistical comparisons were conducted.Approximately 56%/25% of pts in BARI 4 mg, 80%/31% in BARI 2 mg, and 60%/25% in PBO from RA-BUILD remained active at yr 3/7; 59%/17% of pts in ADA, 54%/16% in BARI 4 mg, and 67%/14% in PBO from RA-BEAM remained active at year 3/7. SDAI and CDAI had comparable RR for LDA and REM (Table 1). DAS-28CRP LDA RR were similar to SDAI and CDAI, while REM RR were about twice those of SDAI and CDAI (Table 1). HAQ-DI ≤ 0.5 RR was achieved by 25-30% of BARI-treated pts from both trials and maintained to the end of LTE.Table 1.Efficacy outcomes in RA-BEYONDTimeaN/n (%)LDAREMHAQ-DI ≤0.5SDAICDAIDAS-28 CRPSDAICDAIDAS-28 CRPBooleanRA-BEYOND entryBARI 2 mg (BUILD)197/109197/103200/108197/38 (19.3)197/35 (17.8)200/72 (36.0)200/29 (14.5)200/50 (25.0)(55.3)(52.3)(54.0)BARI 4 mg (BUILD)188/113191/116189/112188/33191/35 (18.3)189/75 (39.7)189/26 (13.8)193/44 (22.8)(60.1)(60.7)(59.3)(17.6)BARI 4 mg (BEAM)412/288414/290412/280412/112414/108412/199412/78 (18.9)414/133 (27.3)(69.9)(70.0)(68.0)(27.2)(26.1)(48.3)Yr 3BARI 2 mg (BUILD)156/120158/116156/112156/41 (26.3)158/44 (27.8)156/81 (51.9)156/34 (21.8)159/38 (23.9)(76.9)(73.4)(71.8)BARI 4 mg (BUILD)107/76107/76107/74107/24107/26 (24.3)107/56 (52.3)107/17 (15.9)108/26 (24.1)(71.0)(71.0)(69.2)(22.4)BARI 4 mg (BEAM)222/166224/166222/164222/72224/71 (31.7)222/119222/48224/54 (24.1)(74.8)(74.1)(73.9)(32.4)(53.6)(21.6)Yr 7BARI 2 mg (BUILD)61/5061/4961/5161/17 (27.9)61/18 (29.5)61/40 (65.6)61/12 (19.7)62/16 (25.8)(82.0)(80.3)(83.6)BARI 4 mg (BUILD)45/3748/3745/3445/13 (28.9)48/16 (33.3)45/25 (55.6)45/8 (17.8)48/14 (29.2)(82.2)(77.1)(75.6)BARI 4 mg (BEAM)60/5364/5760/53 (88.3)60/18 (30.0)64/22 (34.4)60/38 (63.3)60/13 (21.7)64/14 (21.9)(88.3)(89.1)N: Number of pts with observed data; n: Number of pts with response. aTime from randomization in originating studies. Entry to RA-BEYOND=wk 24 and wk 52; Yr 3=wk 156 and wk 160; and Yr 7=wk 360 and wk 364 of RA-BUILD and RA-BEAM, respectively.In observed data, BARI demonstrated maintained efficacy in treatment and maintenance of physical function of a csDMARDs-IR RA pt population up to 7 yrs.[1]Smolen JS, et al. Rheumatology (Oxford). 2021; 60(5):2256-66.Roberto Caporali Speakers bureau: Abbvie, Amgen, BMS, Celltrion, Eli Lilly and Company, Galapagos, Pfizer, Fresenius-Kabi, MSD, UCB, Roche,Janssen, Novartis, Sandoz, Consultant of: Abbvie, Amgen, BMS, Celltrion, Eli Lilly and Company, Galapagos, Pfizer, MSD, UCB, Janssen, Novartis, Sandoz, Daniel Aletaha Speakers bureau: Abbvie, Amgen, Eli Lilly and Company, Janssen, Merck, Novartis, Pfizer, Roche, Sandoz, Grant/research support from: Abbvie, Amgen, Eli Lilly and Company, Novartis, Roche, SoBi, Sanofi, Raimón Sanmartí Speakers bureau: Eli Lilly and Company, Grant/research support from: Eli Lilly and Company, Tsutomu Takeuchi Speakers bureau: AbbVie Japan GK, Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co, Ltd. Daiichi Sankyo Co., Ltd. Eisai Co., Ltd. Eli Lilly Japan K.K.; Gilead Sciences, Inc. Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Co.; Novartis Pharma Co.; Pfizer Japan Inc.; Sanofi K.K.; UCB Japan Co., Ltd., Consultant of: AbbVie Japan GK, Astellas Pharma, Inc.; Chugai Pharmaceutical Co, Ltd.; Eli Lilly Japan K.K.; Eisai Co., Ltd.; Gilead Sciences, Inc.; Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Corp., Pfizer Japan Inc., Grant/research support from: AbbVie Japan GK, Asahikasei Pharma Corp., Chugai Pharmaceutical Co, Ltd., DNA Chip Research Inc.; Eisai Co., Ltd., Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Corp., UCB Japan Co., Ltd., Daojun Mo Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Ewa Haladyj Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Liliana Zaremba-Pechmann: None declared, Peter C. Taylor Consultant of: AbbVie, Biogen, Eli Lilly and Company, Fresenius, Galapagos, Gilead Sciences, GlaxoSmithKline, Janssen, Nordic Pharma, Pfizer Inc, Roche, and Sanofi, Grant/research support from: Celgene, and Galapagos