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Background Based on the totality of evidence, SB2 has shown to be similar with reference infliximab (INF) and has been approved as a biosimilar by the European Medical Agency. It is, however, hitherto unknown, if SB2 also shares similar structural efficacy in the different disease activity states when compared with INF. Objectives To evaluate the disease activity by simplified disease activity index (SDAI) and clinical disease activity index (CDAI) at weeks 14, 30 and 54 in patients with rheumatoid arthritis (RA) treated with SB2 or INF from a phase III study and to assess the radiographic progression at week 54 in patients by disease activity states (remission, low disease activity [LDA], moderate disease activity [MDA], or high disease activity [HDA]). Methods Patients with RA were randomised to receive either SB2 or INF 3 mg/kg at weeks 0, 2, 6, and then every 8 weeks thereafter until week 46 with background methotrexate. Dose increments were allowed after week 30 by 1.5 mg/kg up to a maximum dose of 7.5 mg/kg. Disease activities by SDAI, and CDAI were compared at weeks 14, 30, and 54. The radiographic progression was measured by modified Total Sharp Score (mTSS) at weeks 0 and 54. Results Up to week 54, comparable proportions of patients achieved ACR-EULAR-index remission between SB2 and INF (by SDAI: 13/279 [4.7%] vs. 13/283 [4.6%] at week 14; 24/250 [9.6%] vs. 29/263 [11.0%] at week 30; 34/226 [15.0%] vs. 24/224 [10.7%] at week 54; by CDAI: 12/279 [4.3%] vs. 12/283 [4.2%] at week 14; 22/253 [8.7%] vs. 31/265 [11.7%] at week 30; 33/227 [14.5%] vs. 24/225 [10.7%] at week 54 in SB2 and INF, respectively). The proportions of radiographic non-progressors (defined as change in mTSS ≤0) by disease activity were comparable between SB2 and INF at week 14, 30 and 54 (Table 1). Patients treated with SB2 as well as INF also exhibited the lowest progression of radiographic damage in remission and the largest progression in HDA, but also very small increases in mTSS in LDA and MDA, in line with previous findings on INF. Conclusions The proportion of patients achieving remission or LDA was comparable up to week 54 upon treatment with both SB2 and INF. Inhibition of radiographic progression was also comparable in each disease activity state. The proportion of radiographic non-progressors was also similarly high in patients achieving remission, and overall very low radiographic progression rates were seen even in LDA and MDA in both treatment arms. These data further confirm the comparability of SB2 and INF. Disclosure of Interest J. S. Smolen Consultant for: Abbvie, Amgen, Astra-Zeneca, Astro, Celgene, Glazo, Janssen, Lilly, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung Bioepis, Sanofi, UCB, J.-Y. Choe Consultant for: Samsung Bioepis, E. Keystone Consultant for: Pfizer, Roche, Janssen, Amgen - consultant/Pfizer, Roche, Janssen, Amgen, BMS, Merck. Merck, Celltrion, Samsung Bioepis, Y. H. Rho Employee of: Samsung Bioepis, Y. Lee Employee of: Samsung Bioepis, S. Lee Employee of: Samsung Bioepis

Objectives We compared remission rates, according to different definitions of remission in rheumatoid arthritis (RA) and investigated the potential predictors of sustained remission at the 2-year follow-up. Methods We obtained data on 291 RA outpatients, seen from July 2009 to September 2012. Sociodemographic data and answers to questionnaires were collected in face-to-face interviews. Remission was defined according to the Disease Activity Score in 28 joints (DAS28)-ESR, DAS28-CRP, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), and ACR/EULAR Boolean definition. Sustained remission was defined as when the patient continued in remission at two consecutive annual assessments. Predictors of sustained remission according to the DAS28-CRP were assessed by univariate and multivariate analyses. Results For the 291 RA patients, the remission rates of RA were 17.9% (DAS28-ESR), 54.3% (DAS28-CRP), 10.3% (SDAI), 10.0% (CDAI), and 5.8% (Boolean). On follow-up for 2 years, the sustained remission rates of RA were 46.5% (DAS28), 55.0% (DAS28-CRP), 37.5% (SDAI), 32.0% (CDAI), and 30.8% (Boolean). RA patients who achieve sustained remission according to the DAS28-CRP were younger, and had more education, higher monthly income, lower Health Assessment Questionnaire (HAQ) score, lower physician global assessment, lower patient global assessment, lower patient pain assessment, and higher EQ-5D. In multivariate analysis, only the HAQ score predicted sustained remission according to DAS28-CRP (OR=0.257, 95% CI 0.067–0.980, p =0.047). Conclusions The remission rates of RA patients differed according to the definition of remission, and the highest sustained remission rate was classified by the DAS28-CRP. A lower HAQ score was an independent predictor of sustained remission over 2 years, according to the DAS28-CRP. Disclosure of Interest None declared

Background When initiating therapy with disease-modifying anti-rheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA), treatment adoptions are recommended if no improvement in disease activity is seen within 3 months, or if the treatment target has not been reached by 6 months. 1 A pooled analyses from several pivotal RCTs showed that RA patients who did not achieve a minor treatment response by 3 months were unlikely to reach the treatment target by 6 months. 2 Objectives To examine what level of treatment response is needed after 3 months of therapy in order to achieve the treatment target of remission (REM) or low disease activity (LDA) by 6 months in a routine clinical setting. Methods Data were provided by NOR-DMARD, a prospective, multicentre, observational study. We selected RA-patients enrolled between December 2000 and November 2012, who were biological DMARD-naive and had a moderate or high disease activity (MDA or HDA, respectively) according to the Simplified Disease Activity Index (SDAI) when initiating therapy. All analyses were performed for the total group of included patients (n=1610), as well as for the following sub-groups: disease duration over (n=895) or under (n=681) 12 months, baseline SDAI MDA (n=825) or HDA (n=785), DMARD-naive patients starting methotrexate (MTX) (n=537) and patients starting tumour necrosis factor inhibitor (TNFi) (n=248). We used a diagnostic test approach, created receiver operating characteristic curves and generated sensitivities, specificities and likelihood ratios (LRs) for all improvement cut-points (0–100%) at the 3-month visit. Furthermore, we tested the ability of established response criteria (SDAI 50/70/85 response) at 3 months to predict the desired target of SDAI remission or SDAI LDA at 6 months. Results At inclusion median (IQR) disease duration was 2 (0.2–8.8) years and mean (SD) SDAI was 28.3 (12.8). At 6 months 46.8% of all patients had achieved LDA and 10.8% had reached remission. Not achieving a minor treatment response (SDAI 50% response) by 3 months was associated with decreased probability of reaching remission at 6 months (LR- 0.27), but gave little prognostic information regarding the probability of reaching LDA (LR- 0.49). Patients with HDA at baseline who did not achieve at least 50% improvement in disease activity by 3 months had very low probability of reaching the treatment target by 6 months (LR- 0.15 for remission and LR- 0.30 for LDA). SDAI 85% response at 3 months was predictive of reaching the treatment target at 6 months (LR+ 6.56 for remission and LR+ of 6.45 for LDA). For the total group of patients, a reduction in SDAI of 60.2% was needed at 3 months to predict LDA at 6 months with 80% specificity, while 69.2% improvement was necessary to predict remission. Conclusions These results from a routine clinical setting confirm results from RCTs demonstrating a predictive association between treatment response at 3 months and achievement of the treatment target by 6 months in RA-patients. Assessments at 3 months can inform clinicians to continue or adjust ongoing DMARD-therapy in a treat-to-target strategy aiming for remission or LDA by 6 months. References Smolen JS, et al. Ann Rheum Dis 2014;73(3):492–509. Aletaha D, et al. Ann Rheum Dis 2016;75(8):1479–85. Disclosure of Interest V. Norvang: None declared, I. Olsen: None declared, E. Kristianslund: None declared, T. Uhlig: None declared, T. Kvien Consultant for: AbbVie, Biogen, BMS, Boehringer, Ingelheim, Celltrion, Eli Lilly, Epirus, Janssen, Merck-Serono, MSD, Mundipharma, Norvartis, Oktal, Orion Pharma, Hospira/Pfizer, Roche, Sandoz, UCB, D. Aletaha Consultant for: Abbvie, BMS, Eli Lilly, Janssen, MSD, Pfizer Inc, Roche, UCB, Speakers bureau: Abbvie, BMS, Eli Lilly, Janssen, MSD, Pfizer Inc, Roche, UCB, J. Smolen Grant/research support from: AbbVie, Amgen, AstraZeneca, BMS, Celltrion, Janssen, Lilly, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, UCB, Consultant for: AbbVie, Amgen, AstraZeneca, BMS, Celltrion, Janssen, Lilly, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, UCB, E. Haavardsholm Grant/research support from: AbbVie, Pfizer, Roche, MSD, UCB, Consultant for: AbbVie, Pfizer, Roche, Eli Lilly, Celgene, UCB

Background The association between physical functioning and rheumatoid arthritis (RA) disease activity is well established. In randomized controlled trials (RCTs) of RA treatment, reductions in disease activity result in improved physical functioning. The mental health benefits associated with reductions in disease activity are less well recognized. Objectives Investigate the association between reductions in RA disease activity and measures of mental health status. Methods A systematic review of the published literature of RCTs in RA was conducted. The search was limited to those published in the last 10 years that included the Short-Form (SF)-36 Health Survey as an outcome measure. Results The search strategy yielded 77 articles of which 38 were excluded for the following reasons: not RCT (23); focus exclusively on early RA (9); psychometric evaluation (4); review study (1); and off topic (1). Of the 39 articles reporting mean changes in scores on the SF-36 mental health (MH) and role emotional (RE) domains by treatment group, 3 articles also presented these changes in association with reductions in RA disease activity measures.1–3 In relation to American College of Rheumatology (ACR) response criteria, small to moderate (0.2–0.5 standard deviation [SD]) effect size changes in RE and MH domain scores were observed among RA patients whose ACR responses ranged from 20–49%. Moderate to large effect sizes (0.5–0.8 SD) were reported in RE and MH domain change scores among ACR50 responders. Similar changes in RE and MH domain scores were reported by patients with reductions in Simplified Disease Activity Index (SDAI) of ≥10 points. Conclusions The benefits of clinically meaningful reductions in disease activity among RA patients not only include improved physical functioning but also meaningful improvements in overall mental health status. The improvement in mental health is positively associated with reduction in disease activity, with only small to moderate improvements associated with less than ACR50 responses. Additional work is needed to investigate the incremental effects of RA therapies on mental health beyond the effects related to improvements in disease activity. References Emery P, et al. J Rheumatol. 2006;33(4):681–689. Russell AS, et al. Ann Rheum Dis. 2007;66(2):189–194. Strand V, et al. Health Qual Life Outcomes. 2014;12:31. Disclosure of Interest V. Strand Consultant for: Abbvie, Amgen, AstraZeneca, BiogenIdec, Boehringer Ingelheim, Celltrion, Crescendo, Genentech/Roche, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sanofi and UCB, R. Rendas-Baum Employee of: Optum, M. Kosinski Employee of: Optum, D. Brooks Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, R. Ganguly Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline