FRI0090 MAINTENANCE OF CLINICAL RESPONSE WITH ABATACEPT IN COMBINATION WITH MTX IN INDIVIDUAL PATIENTS WITH EARLY RA WHO ARE MTX-NAÏVE AND ANTI-CITRULLINATED PROTEIN ANTIBODY (ACPA)+: RESULTS FROM THE INDUCTION PERIOD OF AVERT-2, A RANDOMISED PHASE IIIB STUDY

Background: In the 56-wk induction period (IP) of the Phase IIIb Assessing Very Early RA Treatment (AVERT)-2 trial (NCT02504268), more patients (pts) achieved SDAI remission (≤3.3) with abatacept (ABA) + MTX vs ABA placebo (PBO) + MTX at IP Wk 52.1 It is unknown whether each individual pt within a treatment (Tx) group achieves and sustains the same efficacy endpoints at all time points during the IP. Objectives: To investigate whether ABA effectiveness is sustained by individual pts who achieved SDAI remission (≤3.3), SDAI low disease activity (LDA; >3.3–11), DAS28 (CRP) Methods: Pts were randomised 3:2 to blinded SC ABA (125 mg/wk) + MTX or ABA PBO + MTX induction Tx for 56 wks. Key inclusion criteria: age ≥18 yrs; RA diagnosis (ACR/EULAR 2010 criteria); RA duration ≤6 mos; SDAI >11; ACPA+; CRP >3 mg/L or ESR ≥28 mm/h; TJC ≥3 and SJC ≥3; DMARD naive. Response rates were investigated by Tx arm in the cohort 1 analysis population (all randomised pts treated in the IP [intent-to-treat analysis]). Results: Of randomised cohort 1, 752 pts were treated during the IP: 451 with ABA + MTX and 301 with ABA PBO + MTX. Baseline characteristics were similar across Tx arms.1 Stringent SDAI remission endpoint at IP Wk 24 was achieved by 22% of ABA + MTX-treated pts; of these, 56% sustained SDAI remission at IP Wks 40/52 (Table). A similar proportion of ABA + MTX-treated pts achieved (17%) and sustained (58%) Boolean remission at IP Wks 24 and 40/52. At IP Wk 24, 42% of ABA + MTX-treated pts achieved DAS28 (CRP) Conclusion: The majority of individual pts with RA who achieved clinically stringent endpoints such as SDAI remission, DAS28 (CRP) References: [1]Emery P, et al. ACR 2018; San Diego, USA: Poster 563. Acknowledgments: Lola Parfitt (medical writing, Caudex; funding: Bristol-Myers Squibb) Disclosure of Interests: Paul Emery Grant/research support from: AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche (all paid to employer), Consultant of: AbbVie (consultant, clinical trials, advisor), Bristol-Myers Squibb (consultant, clinical trials, advisor), Lilly (clinical trials, advisor), Merck Sharp & Dohme (consultant, clinical trials, advisor), Novartis (consultant, clinical trials, advisor), Pfizer (consultant, clinical trials, advisor), Roche (consultant, clinical trials, advisor), Samsung (clinical trials, advisor), Sandoz (clinical trials, advisor), UCB (consultant, clinical trials, advisor), Yoshiya Tanaka Grant/research support from: Asahi-kasei, Astellas, Mitsubishi-Tanabe, Chugai, Takeda, Sanofi, Bristol-Myers, UCB, Daiichi-Sankyo, Eisai, Pfizer, and Ono, Consultant of: Abbvie, Astellas, Bristol-Myers Squibb, Eli Lilly, Pfizer, Speakers bureau: Daiichi-Sankyo, Astellas, Chugai, Eli Lilly, Pfizer, AbbVie, YL Biologics, Bristol-Myers, Takeda, Mitsubishi-Tanabe, Novartis, Eisai, Janssen, Sanofi, UCB, and Teijin, Vivian Bykerk: None declared, Clifton Bingham Grant/research support from: Bristol-Myers Squibb, Consultant of: Bristol-Myers Squibb, Thomas Huizinga Grant/research support from: Ablynx, Bristol-Myers Squibb, Roche, Sanofi, Consultant of: Ablynx, Bristol-Myers Squibb, Roche, Sanofi, Gustavo Citera Grant/research support from: AbbVie, Amgen, Eli Lilly, Gema, Genzyme, Novartis and Pfizer Inc, Consultant of: AbbVie, Amgen, Eli Lilly, Gema, Genzyme, Novartis and Pfizer Inc, Kuan-Hsiang Gary Huang Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Sean Connolly Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Yedid Elbez Consultant of: Bristol-Myers Squibb, Robert Wong Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Karissa Lozenski Employee of: Bristol-Myers Squibb, Roy Fleischmann Grant/research support from: AbbVie, Akros, Amgen, AstraZeneca, Bristol-Myers Squibb, Boehringer, IngelhCentrexion, Eli Lilly, EMD Serono, Genentech, Gilead, Janssen, Merck, Nektar, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Roche, Samsung, Sandoz, Sanofi Genzyme, Selecta, Taiho, UCB, Consultant of: AbbVie, ACEA, Amgen, Bristol-Myers Squibb, Eli Lilly, Gilead, GlaxoSmithKline, Novartis, Pfizer, Sanofi Genzyme, UCB