Search

ObjectiveTo compare efficacy and safety of subcutaneous sarilumab 200 mg and 150 mg every 2 weeks plus conventional synthetic disease-modifying antirheumatic drugs (+csDMARDs) versus other targeted DMARDs+csDMARDs and placebo+csDMARDs, in inadequate responders to csDMARDs (csDMARD-IR) or tumour necrosis factor α inhibitors (TNFi-IR).MethodsSystematic literature review and network meta-analyses (NMA) conducted on 24 week efficacy and safety outcomes: Health Assessment Questionnaire Disability Index, modified total sharp score (mTSS, including 52 weeks), American College of Rheumatology (ACR) 20/50/70, European League Against Rheumatism Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28)Results53 trials were selected for NMA. csDMARD-IR: Sarilumab 200 mg+csDMARDs and 150 mg+csDMARDs were superior versus placebo+csDMARDs on all outcomes. Against most targeted DMARDs, sarilumab 200 mg showed no statistically significant differences, except superiority to baricitinib 2 mg, tofacitinib and certolizumab on 24 week mTSS. Sarilumab 150 mg was similar to all targeted DMARDs. TNFi-IR: Sarilumab 200 mg was similar to abatacept, golimumab, tocilizumab 4 mg and 8 mg/kg intravenously and rituximab on ACR20/50/70, superior to baricitinib 2 mg on ACR50 and DAS28ConclusionsResults suggest that in csDMARD-IR and TNFi-IR (a smaller network), sarilumab+csDMARD had superior efficacy and similar safety versus placebo+csDMARDs and at least similar efficacy and safety versus other targeted DMARDs+csDMARDs.

Background When tumor necrosis factor inhibitor (TNFi) therapy fails in rheumatoid arthritis (RA), a majority of patients switch to another TNFi instead of a non-TNFi biologic disease-modifying antirheumatic drug (bDMARD). 1 The effectiveness of TNFi cycling compared with switching to a non-TNFi agent is not well established. Objectives This study examined treatment effectiveness among patients with RA in a large, commercially insured population who cycled to another TNFi (“TNFi cyclers”) compared with those who switched to a non-TNFi agent (“non-TNFi switchers”). Methods Administrative claims from January 2010 to September 2014 were analyzed from the Truven Health MarketScan Commercial database. Eligible patients received a TNFi in the 12 months before the “index” drug (a different TNFi or non-TNFi [bDMARDs or tofacitinib]). The study included adults ages 18 to 64 years with ≥12 months of continuous medical and pharmacy enrollment pre- and post-index, and ≥1 claim for RA (ICD-9-CM 714.0x) pre-index or 30 days post-index with no other autoimmune condition. Treatment effectiveness was defined using a validated algorithm 2 that was applied to medical and pharmacy claims for 12 months post-index for each patient. Treatment was considered to be effective if the patient satisfied all 6 algorithm criteria in this period: (1) ≥80% adherence (subcutaneous medication possession ratio or number of intravenous infusions); (2) no increase in dose; (3) no switch to another bDMARD; (4) no new conventional DMARD; (5) no new/increased oral glucocorticoid; and (6) less than 2 glucocorticoid injections in the first 90 days after the index date. Logistic regression was used to compare effectiveness rates by treatment cohort, controlling for baseline demographic and clinical characteristics, including number of prior biologic therapies. Results Of the 6,945 patients who switched from a pre-index TNFi, 5,020 (72.3%) were TNFi cyclers and 1,925 (27.7%) were non-TNFi switchers. Achievement rates for all 6 algorithm criteria combined and for individual criteria in the 12 months post-index are shown in the table. In the logistic regression model, non-TNFi switchers were 1.25 times as likely as TNFi cyclers to achieve all algorithm criteria for effectiveness (odds ratio, 1.248; 95% CI, 1.103–1.414; P Conclusions On the basis of a claims-based algorithm of treatment effectiveness for RA, it appears that patients who switch from TNFi to non-TNFi agents are more likely to achieve treatment effectiveness criteria for 12 months after switching than patients who cycle to another TNFi. References Bonafede M et al. Adv Ther. 2012;29:664–674. Curtis JR, et al. Arthritis Res Ther. 2011;13:R155. Acknowledgement This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Jonathan Latham assisted with preparation and submission of the abstract. Disclosure of Interest M. Bonafede Employee of: Truven Health, which was awarded a research contract from Sanofi and Regeneron Pharmaceuticals for this work, J. Curtis Consultant for: Sanofi and Regeneron Pharmaceuticals, Inc., D. McMorrow Employee of: Truven Health, which was awarded a research contract from Sanofi and Regeneron Pharmaceuticals for this work, P. Mahajan Shareholder of: Sanofi, Employee of: Sanofi, C. Chen Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc.

Background Recent studies suggested that in rheumatoid arthritis (RA) patients discontinuing their prior tumor necrosis factor inhibitor (TNFi), treatment persistence was greater in those switching to a disease-modifying antirheumatic drug (DMARD) with a new mechanism-of-action (MOA) than in those cycling to a second TNFi. Objectives To evaluate in RA patients real-world treatment persistence and clinical outcomes associated with TNFi cycling vs switching to a new MOA DMARD. Methods This retrospective analysis of RA patients used the US clinical JointMan® database, an evidence-based rheumatology software application that rheumatologists use to systematically document patient-level data in routine clinical practice. Adult RA patients were included if they had a physician prescription record of a TNFi from April 1, 2010 through March 31, 2015 and a subsequent DMARD that was a different TNFi (TNFi cycling cohort) or new MOA DMARD (new MOA DMARD switching cohort). Patients were indexed on the date of the subsequent TNFi or new MOA DMARD from a prior TNFi during the pre-index period. Treatment persistence was assessed, defined as neither discontinuing nor switching the drug post-index before the end of the observational period. Change in Clinical Disease Activity Index (CDAI) at 1 year post-index and its correlation with treatment persistence were evaluated. Kaplan-Meier survival analysis measured time to nonpersistence. Cox proportional hazards regression and ordinary least-squares regression were used to identify independent factors predicting time to nonpersistence and 1-year CDAI change, respectively. Results Included were 613 patients (mean age 56.5 years; 78.5% women; 82.9% white; baseline CDAI 22.7). After discontinuing a prior TNFi, 54.2% (n=332) of patients cycled to another TNFi and 45.8% (n=281) switched to a new MOA DMARD. During follow-up, 36.7% (n=225) of patients were persistent with their index drug, 34.1% (n=209) switched from their index drug to another drug, and 29.2% (n=179) discontinued their index drug. Compared with TNFi cyclers, new MOA DMARD switchers were more likely to be persistent at 1 year (45.2% vs 29.5%; P P P =0.027); however, this effect was not statistically significant when baseline CDAI was controlled for in the regression model (−5.83 vs −6.39; P =0.607). Overall, treatment persistence was associated with a significantly higher reduction in CDAI (−8.69 vs −3.16; P Conclusions This real-world study suggests that after discontinuing their prior TNFi, RA patients who switched to a new MOA DMARD demonstrated better treatment persistence than those cycling to another TNFi. Persistence with RA treatment was associated with better clinical outcome. Acknowledgement Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Editorial assistance provided by I. Ouwehand, PhD, of Excerpta Medica, funded by Sanofi and Regeneron Pharmaceuticals, Inc. Disclosure of Interest W. Wei Shareholder of: Sanofi, Employee of: Sanofi, K. Knapp Employee of: Arthritis Northwest and Discus Analytics, Inc., L. Wang Consultant for: Sanofi and Regeneron Pharmaceuticals, Inc., Employee of: STATinMED research, C. Chen Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., G. Craig Shareholder of: Discus Analytics, Inc., Employee of: Arthritis Northwest and Discus Analytics, Inc., K. Ferguson Shareholder of: Discus Analytics, Inc., Employee of: Arthritis Northwest and Discus Analytics, Inc., S. Schwartzman Shareholder of: Discus Analytics, Inc., Consultant for: Discus Analytics, Inc.

Background Efficacy, including improvements in patient-reported outcomes (PROs), was demonstrated in 2 phase 3 trials, MOBILITY 1 (NCT01061736) and TARGET 2 (NCT01709578), of sarilumab, an investigational human anti–interleukin 6 receptor monoclonal antibody. The most common treatment-emergent adverse events in both studies were infections, neutropenia, injection site reactions, and increased transaminases. Objectives To evaluate the early onset of benefit of sarilumab treatment measured by PROs. Methods In both studies, adults with moderate-to-severe, active rheumatoid arthritis (RA) were randomized to 1 of 3 groups receiving placebo, sarilumab 150 mg, or sarilumab 200 mg subcutaneously (SC) every 2 weeks (q2w) plus methotrexate (MTX; MOBILITY) or conventional synthetic disease-modifying antirheumatic drugs (csDMARDs; TARGET). PROs assessed as early as week 2 included patient global assessment of disease activity (PtGA), pain assessed by visual analog scale (VAS), Health Assessment Questionnaire–Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), sleep by VAS (MOBILITY), and AM stiffness by VAS (TARGET). Changes from baseline were analyzed using mixed-model repeated measures with region, number of prior tumor necrosis factor inhibitors (TNFis) (TARGET) or prior biologic use (MOBILITY), visit, treatment, treatment-by-visit interaction, and baseline PRO scores as covariates. Results Greater improvements were reported by patients treated with sarilumab 150 and 200 mg SC q2w vs placebo as early as week 2 in PtGA, pain VAS, HAQ-DI, FACIT-F, sleep VAS, and AM stiffness VAS (nominal P Conclusions Sarilumab treatment rapidly improved a broad range of PROs in patients with RA with inadequate response to MTX (MOBILITY) or TNFis (TARGET); these improvements were observed as early week 2 and maintained through week 24. The results demonstrate the early benefit of sarilumab treatment based on patients9 own assessments of their disease. References Genovese et al. Arthritis Rheumatol. 2015;67:1424–1437. Fleischmann et al. Arthritis Rheumatol. 2015;67(suppl 10). Acknowledgement This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Disclosure of Interest V. Strand Consultant for: AbbVie, Amgen, AstraZeneca, Biogen, BMS, Celgene, Celltrion, Consortium of Rheumatology Researchers of North America (CORRONA), Crescendo/Myriad Genetics, EMD Serono, Genentech/Roche, GSK, Janssen, Eli Lilly, Novartis, Pfizer Inc, Regeneron Pharmaceuticals, Inc, Sandoz, Sanofi, and UCB, C. Chen Shareholder of: Regeneron Pharmaceuticals, Inc, Employee of: Regeneron Pharmaceuticals, Inc, P. Mahajan Shareholder of: Sanofi, Employee of: Sanofi, M. Kosinski Consultant for: Sanofi and Regeneron, E. Mangan Shareholder of: in Pfizer Inc and Regeneron Pharmaceuticals, Inc, Employee of: Regeneron Pharmaceuticals, Inc, H. van Hoogstraten Shareholder of: Sanofi, Employee of: Sanofi, N. Graham Shareholder of: Regeneron Pharmaceuticals, Inc, Employee of: Regeneron Pharmaceuticals, Inc, Y. Lin Shareholder of: Sanofi, Employee of: Sanofi, E. Keystone Consultant for: has consulting agreements/advisory board membership with Abbott, AstraZeneca, Biotest, BMS, F. Hoffman-La Roche, Genentech, Janssen, Eli Lilly, Merck, Pfizer Inc, and UCB; and has speaker honoraria agreements with Abbott, Amgen, AstraZeneca, BMS Canada, F. Hoffman-La Roche, Janssen, Pfizer Inc, and UCB., J. Braun Grant/research support from: received honoraria for talks, advisory boards, paid consultancies, and grants for studies from AbbVie (Abbott), Amgen, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Hospira, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer Inc (Wyeth), Roche, Sanofi-Aventis, and UCB, Consultant for: received honoraria for talks, advisory boards, paid consultancies, and grants for studies from AbbVie (Abbott), Amgen, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Hospira, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer Inc (Wyeth), Roche, Sanofi-Aventis, and UCB

Background When a patient with rheumatoid arthritis (RA) fails initial treatment with a tumor necrosis factor inhibitor (TNFi) because of inadequate response or lack of tolerability, switching to another TNFi or to a non-TNFi is recommended, but this is based on limited evidence. 1,2 Objectives This study examined real-world treatment patterns between patients with RA who switched from a TNFi to another TNFi (TNFi cyclers) compared with those who switched from a TNFi to a non-TNFi (non-TNFi switchers). Methods The data source was an administrative claims database from a large managed care organization of commercial and Medicare Advantage patients in the United States. The “index claim” was the first TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) claim between January 2010 and February 2014 after ≥6 months of continuous enrollment pre-index. Eligible patients were aged ≥18 years at index with RA and no other autoimmune condition for which the study drugs could be used. The study included patients who subsequently switched either to another TNFi or to a non-TNFi (abatacept, tocilizumab, or tofacitinib) within 12 months post-index and had ≥12 months of additional follow-up. Each patient had 1 of 4 treatment patterns in the 12 months after the initial switch: (1) switched to a third TNFi or non-TNFi; (2) restarted the second therapy after a treatment gap of ≥45 days without switching; (3) discontinued the second therapy without switching or restarting; or (4) persisted with the second therapy without switching, restarting, or discontinuing. Adherence was defined as a proportion of days covered (PDC) of ≥80% for the second therapy. Results Of 32,272 adult patients with RA who received ≥1 biologic, 1432 met all study criteria, including 379 non-TNFi switchers and 1053 TNFi cyclers. Most patients (81%) were female. Non-TNFi switchers were older (54.0 vs 51.1 y; P P P =0.021) and significantly less likely to switch to a third TNFi or non-TNFi (29% vs 37%; P =0.006); non-TNFi switchers and TNFi cyclers had similar rates of restarting therapy after a ≥45-day treatment gap (6% vs 8%; P =0.325) and discontinuation without restarting or switching therapy (14% vs 11%; P =0.185). In the 12 months after the initial switch, non-TNFi switchers were significantly more likely than TNFi cyclers to have high adherence (≥80% PDC) to the second medication (45% vs 38%; P =0.021). Conclusions Among patients with RA, those who switched from a TNFi to a non-TNFi were more likely than TNFi cyclers to be persistent on the second medication in the first year, had greater adherence to the second medication, and were less likely to switch therapy again in the first year. The implications for clinical treatment outcomes deserve further study. References Singh et al. Arthritis Care Res (Hoboken). 2012;64:625–639. Smolen et al. Ann Rheum Dis. 2014;73:492–509. Acknowledgement This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Jonathan Latham assisted with preparation and submission of the abstract. Disclosure of Interest B. Chastek Employee of: Optum, which was hired by Sanofi and Regeneron Pharmaceuticals to conduct the research, J. Curtis Consultant for: Sanofi and Regeneron Pharmaceuticals, L. Becker Employee of: Optum, which was hired by Sanofi and Regeneron Pharmaceuticals to conduct the research, P. Mahajan Shareholder of: Sanofi, Employee of: Sanofi, C. Chen Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc.

Background The effect of active rheumatoid arthritis (RA) on participation, active and meaningful engagement by patients in activities important to them, has significant individual and societal costs. Sarilumab is an investigational human anti–interleukin 6 (IL-6) receptor monoclonal antibody. In the phase 3 TARGET study (NCT01709578), sarilumab + conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) demonstrated efficacy in adults with moderate-to-severe, active RA and inadequate response to TNF inhibitors. The most common treatment-emergent adverse events were infections, neutropenia, and increased transaminases; laboratory changes were consistent with IL-6 signaling blockade. Objectives To evaluate the effect of sarilumab treatment on patient productivity within and outside of the home; requirement for outside help; and family, social, or leisure activities in the past month as assessed by the RA-specific Work Productivity Survey (WPS-RA). 1 Methods The intent-to-treat population included 546 patients randomized 1:1:1 to placebo, sarilumab 150 mg, or sarilumab 200 mg every 2 wks (q2w) subcutaneously (SC) + background csDMARDs. The WPS-RA was assessed for patients employed outside of (completed all 8 items) and within the home (completed only the 5 items related to productivity within the home and participation in family, social, and leisure activities) at baseline and wks 4 (not reported), 12, and 24. Mixed-model repeated measures analyses were used to evaluate differences in individual WPS-RA items at a significance level of 0.05 if O9Brien9s global test 2 showed significance ( P Results At baseline, 544 patients were administered the WPS-RA, 33.1%, 33.7%, and 35.7% (placebo, sarilumab 150, and sarilumab 200 mg q2w SC, respectively) of whom were currently employed outside of the home. Global testing indicated significantly greater overall improvement in patients treated with sarilumab 150 mg q2w SC (wk 12, P =0.0010; wk 24, P =0.0004) and sarilumab 200 mg q2w SC (wk 12, P =0.0036; wk 24, P =0.0003) vs placebo. At wk 24, patients currently employed outside of the home receiving sarilumab 200 mg q2w SC reported significantly greater reductions in number of work days missed due to RA and less interference with work productivity. Patients receiving both doses reported significantly greater reductions in number of days missed engaging in household work, days requiring hired help, and rate of arthritis interference in household work and less time missed engaging in family, social, and leisure activities. Conclusions Sarilumab treatment was associated with significant improvements in participation in work; household work; and family, social, and leisure activities. Improvements in productivity outside of the home were also significant among patients in the sarilumab 200 mg q2w SC group vs placebo, although only a proportion of patients worked outside of the home. These data indicate important improvements in overall participation following sarilumab treatment. References Osterhaus et al. Arthritis Res Ther. 2009;11:R73 Tandon. Stat Med. 1990;9:819–827 Acknowledgement This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Disclosure of Interest V. Strand Consultant for: has received consulting fees from AbbVie, Amgen, AstraZeneca, Biogen, BMS, Celgene, Celltrion, Consortium of Rheumatology Researchers of North America (CORRONA), Crescendo/Myriad Genetics, EMD Serono, Genentech/Roche, GSK, Janssen, Eli Lilly, Novartis, Pfizer Inc, Regeneron Pharmaceuticals, Inc, Sandoz, Sanofi, and UCB., P. Mahajan Shareholder of: Sanofi, Employee of: Sanofi, C. Chen Shareholder of: Regeneron Pharmaceuticals, Inc, Employee of: Regeneron Pharmaceuticals, Inc, H. van Hoogstraten Shareholder of: Sanofi, Employee of: Sanofi, E. Mangan Shareholder of: an employee of Regeneron Pharmaceuticals, Inc, and may hold stock and/or stock options in Pfizer Inc and Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc, O. Hagino Shareholder of: Sanofi, Employee of: Sanofi, N. Graham Shareholder of: Regeneron Pharmaceuticals, Inc, Employee of: Regeneron Pharmaceuticals, Inc, G. da R.C. Pinheiro Consultant for: has received consulting fees from AbbVie, AstraZeneca, GSK, Hospira, Janssen, Pfizer Inc, Roche, RuiYi, and Sanofi., A. Kivitz Consultant for: has received consulting fees from Celgene, Genentech/Roche, GSK, Janssen, Pfizer Inc, Regeneron Pharmaceuticals, Inc, Sanofi, and UCB.

Background Clinical and patient reported outcomes provide complimentary information about the efficacy of treatment in RCTs in RA. Linking these two may improve our understanding of treatment benefit. The MOBILITY intent-to-treat population included 1,197 patients randomized 1:1:1 to placebo+MTX, sarilumab 150mg every two weeks (q2w) +MTX or 200mg q2w+MTX. Most common TEAEs included infections and injection site reactions. A higher incidence of serious infections was observed with sarilumab 1 . Objectives To evaluate reported improvements in HRQoL by ACR20 responders in this phase 3 RCT. Methods HRQoL was measured using the SF-36v2; fatigue by FACIT-Fatigue. Only ACR20 responders were included, since there were few ACR50 responders in the placebo group and no differences in baseline characteristics of responders between treatment groups. At wk 24, we calculated the percentage of ACR20 responders that met or exceeded: 1) PASS 2,3 , a state of well-being which patients consider to be satisfactory, in 6 SF-36v2 domains; 2) general population normative values for SF-36v2 and FACIT-Fatigue scores. Differences from placebo were tested for statistical significance (p Results ACR20 responses were 33.5% in placebo, 58.4% in 150mg and 66.4% in 200mg sarilumab groups. The percentages of responders in both 150mg and 200mg sarilumab groups with scores ≥PASS at wk 24 exceeded placebo across all 6 SF-36 domains; statistically significant for physical functioning, vitality, social functioning and mental health domains. For example, 82.7% (150mg) and 87.6% (200mg) sarilumab patients reported improvements ≥PASS in SF-36v2 vitality domain vs 72.7% placebo. The percentages of responders receiving 150mg and 200mg sarilumab with scores ≥normative values at wk 24 exceeded placebo across all SF-36v2 domains and FACIT; statistically significant for SF-36v2 bodily pain, vitality, mental health domains; mental component summary score and FACIT. For example, 46.3% (150mg) and 54% (200mg) of sarilumab patients reported scores ≥normative values in SF-36v2 vitality domain vs 38.6% placebo. Similar findings were observed at wk 52. Conclusions Among ACR20 responders, those receiving sarilumab+MTX reported better HRQoL than with placebo+MTX, particularly in measures of bodily pain, vitality, and fatigue by SF-36 and FACIT. Largest percentage differences vs placebo were observed based on scores attaining normative values, which were more discriminative for the Sarilumab 200mg dose than PASS. Observed differences may be driven in part by more high level responders in the active treatment groups. References Genovese M et al. Abstr. EULAR14-SCIE-3001, EULAR 2014 Heiberg T et al. Ann Rheum Dis 2008;67:967-971 Strand V et al. J Rheumatol. 2011;38(8):1720-1727 Acknowledgements The study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Editorial support was provided by Jennifer Dunphy of Optum and was funded by Sanofi and Regeneron Pharmaceuticals Inc. Disclosure of Interest V. Strand Consultant for: AbbVie, Afferent, Amgen, Biogen Idec, Bioventus, BMS, Carbylan, Celgene, Celltrion, Consortium of Rheumatology Researchers of North America (CORRONA), Crescendo, Genentech/Roche, GSK, Hospira, Iroko, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi, SKK, Takeda, UCB, Vertex, M. Kosinski Consultant for: Sanofi, Regeneron, G. Joseph Shareholder of: Amgen Inc, Pfizer Inc., Employee of: Sanofi, C. Chen Employee of: Regeneron Pharmaceuticals, H. Van Hoogstraten Employee of: Sanofi, N. Graham Shareholder of: Regeneron Pharmaceuticals, Employee of: Regeneron Pharmaceuticals, T. Huizenga Consultant for: Merck, UCB, Bristol Myers Squibb, Biotest AG, Pfizer, Novartis, Roche, Sanofi-Aventis, Abbott, Crescendo Bioscience, Nycomed, Boeringher, Takeda, Zydus, and Eli Lilly, Speakers bureau: Merck, UCB, Bristol Myers Squibb, Biotest AG, Pfizer, Novartis, Roche, Sanofi-Aventis, Abbott, Crescendo Bioscience, Nycomed, Boeringher, Takeda, Zydus, and Eli Lilly, M. Genovese Grant/research support from: Sanofi, Regeneron Pharmaceuticals, Eli Lilly, Consultant for: Sanofi, Regeneron Pharmaceuticals, Eli Lilly

Background The ultimate goal of RA treatment is to achieve disease remission. Studies have shown that objective, measure-based treatment decision-making leads to improved patient outcomes. In addition, the National Quality Forum (NQF) recently endorsed three measures for RA, including assessment of disease activity using a standardized tool. However, in clinical practice physicians may still rely on subjective assessment of disease activity. Objectives To compare physician-reported and DAS28-based clinical assessments of RA disease remission. Methods Data were drawn from the Adelphi RA-DSP, a cross-sectional survey of United States rheumatologists and their RA patients between January and March 2014. Clinical remission status (DAS28 ESR Results Included in the analysis were 531 RA patients (75% female, mean age 56.4 years, 7.7 years since RA diagnosis, 53% treated with biologic) in the care of 78 rheumatologists (31% female, 37% practice only in office). 56% of physicians reported using only subjective criteria to assess remission; 30% of patients were evaluated using a standardized disease activity measure during last visit. While physicians reported 50% of patients were in remission, 32% were in remission by DAS28 criteria. Remission status was over-reported by physicians in 25% and underreported in 7% of patients. Regression analyses indicated that physician over-reporting was significantly higher among patients treated with biologics (Relative Risk Ratio (RRR)=2.01, P=0.003), those in the care of physicians with high RA workload (RRR=2.51, P=0.011), and patients considered by their physicians to have “satisfactory” RA control (RRR=6.09, P Physician under-reporting was significantly higher among obese patients (RRR=2.95, P=0.002), patients with average general health level (RRR=2.03, P=0.029), and those with more than 5 tender or swollen joints (RRR=2.72, P=0.019), but significantly lower among patients with medium to high current pain level (RRR=0.18, P=0.004) or those who saw physicians with high RA workload (RRR=0.43, P=0.029). Conclusions This study points out the need to increase the use of standardized measures of RA disease activity, and ensure consistency of use across clinical care. Addressing these gaps in care may help optimize treatment decisions, reduce variability in delivery of patient care and ultimately improve RA patient outcomes. Disclosure of Interest W. Wei Shareholder of: Sanofi, Employee of: Sanofi, C. Chen: None declared, E. Sullivan: None declared, S. Blackburn: None declared, J. Curtis Grant/research support from: Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie, Consultant for: Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie

Background RA patients may require additional medication or increased doses to successfully manage active disease. The ability to identify variables that predict this need could result in more effective treatment. Objectives To identify baseline predictors for rescue medication in the intent-to-treat population (N=1,197) enrolled in MOBILITY. Methods Patients were randomized 1:1:1 to receive placebo+MTX, sarilumab 150mg every 2 wks (q2wk)+MTX or 200mg q2wk+MTX. Outcomes were assessed at baseline, every 4 wk from wk 2 –28; every 8 thereafter to wk 52. On or after wk 16, patients with Results 940 patients never received rescue medication, 153 were rescued early and 104 between wks 20 – 52. The percentages of no, early and late rescued patients were 61%, 15% and 24% for placebo; sarilumab 150mg: 86%, 6% and 8% and 200mg: 89%, 4% and 7%, respectively. Baseline SJC, TJC, DAS28, SDAI, CDAI, SF-36 Vitality (VT) domain and FACIT-Fatigue (FACIT-F) scores independently predicted the need for rescue medication. In MLMs, treatment group, DAS28, SF-36 VT and FACIT scores were most strongly associated with rescue. Estimated odds ratios (OR) for early rescue vs no rescue for placebo patients were 4.6/5.2 times higher than for sarilumab 150mg/200mg. 2 and 4 point higher baseline DAS28 scores were associated with 78%/218% increases in OR for “early rescue”; 5 and 10 point lower SF-36 VT scores with 5% and 10% increased OR. 5 and 10 lower scores in FACIT increased the OR for early rescue by 7% and 13%. Conclusions Sarilumab treatment lowered the odds for requiring early and late rescue. DAS28 scores and PROs of pep, energy and fatigue predicted the need for rescue among MOBILITY patients across all treatment arms, highest in placebo. These results may help clinicians to better target RA therapy. Acknowledgements The study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Editorial support was provided by Jennifer Dunphy of Optum and was funded by Sanofi and Regeneron Pharmaceuticals Inc. Disclosure of Interest V. Strand Consultant for: AbbVie, Afferent, Amgen, Biogen Idec, Bioventus, BMS, Carbylan, Celgene, Celltrion, Consortium of Rheumatology Researchers of North America (CORRONA), Crescendo, Genentech/Roche, GSK, Hospira, Iroko, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi, SKK, Takeda, UCB, Vertex, R. Rendas-Baum Consultant for: Sanofi, Regeneron Pharmaceuticals, C. Chen Employee of: Regeneron Pharmaceuticals, G. Joseph Shareholder of: Amgen Inc., Pfizer Inc., Employee of: Sanofi, N. Graham Shareholder of: Regeneron Pharmaceuticals, Employee of: Regeneron Pharmaceuticals, H. Van Hoogstraten Employee of: Sanofi, M. Genovese Grant/research support from: Sanofi, Regeneron Pharmaceuticals, Eli Lilly, Consultant for: Sanofi, Regeneron Pharmaceuticals, Eli Lilly, T. Huizenga Consultant for: Merck, UCB, Bristol Myers Squibb, Biotest AG, Pfizer, Novartis, Roche, Sanofi-Aventis, Abbott, Crescendo Bioscience, Nycomed, Boeringher, Takeda, Zydus, and Eli Lilly, Speakers bureau: Merck, UCB, Bristol Myers Squibb, Biotest AG, Pfizer, Novartis, Roche, Sanofi-Aventis, Abbott, Crescendo Bioscience, Nycomed, Boeringher, Takeda, Zydus, and Eli Lilly