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Background Early RA patients (pts) often present with different areas of joint involvement, but limited data exist to identify which specific joint locations may be indicative of greater disease severity1. Objectives This analysis investigated the baseline (BL) prevalence of swelling and erosions in individual joint locations and their possible association with disease characteristics and prognostic factors in a unique cohort of early erosive RA patients using the AGREE study population. Methods In this post-hoc analysis of the Phase III AGREE study where methotrexate (MTX) naive RF and/or ACPA seropositive pts with early (≤2 years [yrs]) erosive RA were treated with abatacept (ABA) plus MTX (n=256) or MTX (n=253)2, prevalence of BL swollen joint status (present, absent) was analysed for 6 large and 14 small joint locations: respectively wrists, elbows, shoulders, jaw, knees, ankles and MCP1-5, PIP2-5 and MTP1-5. Similarly, prevalence of BL erosive joint status was analysed for wrist, MCP1-5, PIP2-5 and MTP1-5. The association between BL disease characteristics and BL swelling or erosions was investigated for the individual joints. Results In this cohort of early, seropositive erosive RA (n=509), BL swelling was most frequently observed in the wrist (91.90%) and MCP2 joint (90.1%), whereas BL erosion was most frequently observed in the MTP5 joint (43.5%) (Table 1). BL swelling in the knee, jaw, wrist and elbow was highly associated (p Conclusion In this cohort of early, seropositive erosive RA, swelling in the knee, jaw, wrist and elbow seems to be associated with the poorest prognosis, whereas BL MCP2 swelling seems to be associated with joint damage. While the data require further validation, a difference in joint location presentation may identify patients for an intensive treatment or a personalized treatment approach. References [1] Bergstra SA, et al. RMD Open2017;3:e000568. [2] Westhovens, et al. Ann Rheum Dis2009;68:1870–7. Disclosure of Interests Patrick Durez Speakers bureau: Bristol-Myers Squibb, Eli Lilly, Sanofi, Celltrion, Rene Westhovens Grant/research support from: Bristol-Myers Squibb, Consultant for: Celltrion, Galapagos-Gilead, Yedid Elbez Employee of: Employee of Excelya which received funding from Bristol-Myers Squibb as contract research organization., Sofie Robert Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Harris A Ahmad Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb

Background In the placebo (PBO)-controlled Phase III aSTRAEA study (ClinicalTrials.gov, NCT01860976) in psoriatic arthritis (PsA), abatacept (ABA) 125 mg SC weekly significantly increased the aCR20 response rate at Week 24 versus PBO (39.4% vs 22.3%, respectively; p Objectives To assess aBA safety up to 2 years in patients (pts) enrolled in aSTRAEA. Methods Pts with active PsA were randomised 1:1 to aBA or PBO for 24 weeks followed by 28 weeks’ open-label (OL) aBA (total time on study: 52 weeks); pts without ≥20% improvement in joint counts at Week 16 (early escape) were switched to OL aBA (total time on study: 44 weeks).1 Pts could subsequently receive OL aBA in a 52-week long-term extension (LTE; Year 2) for the collection of safety data. The proportions of pts in the cumulative aBA population (all pts who received ≥1 dose of aBA at any time in the study) with aEs (all aEs, serious aEs [SAEs], deaths, aEs leading to discontinuation), laboratory marked abnormalities and anti-ABA antibodies over the cumulative aBA period (date of first treatment dose to end of LTE) were recorded in 1-year and 6-month intervals. Results Overall, 398 pts were included in the analysis of the cumulative aBA period (213 received aBA from study Day 1; 185 completed initial randomisation to PBO and received aBA thereafter). Of these, 322 pts entered the LTE (initial randomisation: aBA, n=162; PBO, n=160) and continued to receive OL aBA beyond the 28-week OL period. Of 162 and 160 pts initially randomised to aBA and PBO, respectively, 19 (11.7%) and 21 (13.1%) pts discontinued aBA in the LTE. Median (range) number of aBA injections in the cumulative aBA period to end of LTE was 80 (1–133). Safety during the cumulative aBA period over 2 years is shown (Table 1); 6-month interval safety data will be available at time of presentation. In the LTE, there were 3 SAEs of infection (osteomyelitis, intervertebral discitis and cellulitis) and 3 pts discontinued due to infection (hepatitis a, Epstein-Barr virus, intervertebral discitis). No malignancies or deaths were reported, and no autoimmune events were reported as serious or led to aBA discontinuation during the LTE. AEs, SAEs and aEs of special interest occurred with a similar frequency regardless of concomitant MTX or prior TNF inhibitor (TNFi) use. The proportion of pts with anti-ABA antibodies during the cumulative aBA period was higher during the post-treatment period (≥22 days after last dose; 37.1% [91/245]) than in the on-treatment period (first treatment dose date to ≤21 days after last dose; 7.1% [28/392]). No apparent relationship between anti-ABA antibodies and efficacy in the on-treatment period or aEs suggestive of systemic immune reactions was seen. Conclusion Abatacept was well tolerated up to 2 years with no new safety signals during the LTE in this Phase III study in PsA. There was no impact of concomitant MTX use or prior TNFi exposure on the safety profile of abatacept. The occurrence of anti-abatacept antibodies had no impact on abatacept efficacy or safety. References [1] Mease PJ, et al. Ann Rheum Dis2017;76:1550–8. Acknowledgement Professional medical writing: andrea Plant, PhD, Caudex; funding: Bristol-Myers Squibb. Disclosure of interests Philip J Mease Grant/research support from: abbVie, amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Consultant for: abbVie, amgen, BMS, Galapagos, Gilead Sciences, inc., Janssen, Lilly, Novartis, Pfizer, SUN and UCB, Speakers bureau: abbVie, amgen, BMS, Celgene, Genentech, Janssen, Lilly, Novartis, Pfizer and UCB, alice B Gottlieb Grant/research support from: PI: incyte Corporation, Janssen-Ortho inc., Lilly ICOS LLC, Novartis, UCB, XBiotech, Consultant for: abbVie, Dermira, incyte Corporation, Lilly ICOS LLC, Novartis, Sun Pharmaceutical industries Ltd., avotres (unpaid), XBiotech (unpaid), Speakers bureau: abbVie, Eli Lilly and Company, Janssen Biotech; advisory board: Bristol-Myers Squibb, Celgene Corporation, Janssen Biotech, Janssen-Ortho inc., LEO Pharma, Novartis, UCB, Desiree van der Heijde Consultant for: abbVie, amgen, astellas, astraZeneca, Bristol-Myers Squibb, Boehringer ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, Union Chimique Belge, Oliver FitzGerald: None declared, alyssa Johnsen Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Marleen Nys Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Subhashis Banerjee Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Harris a ahmad Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Dafna D Gladman Grant/research support from: abbVie, amgen, Celgene, Lilly, Novartis, Pfizer, and UCB, Consultant for: abbVie, amgen, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB

Background To assist in clinical decision making it is important to understand the factors, and their thresholds, that might predict relapse following treatment withdrawal in patients with RA in remission. In a previous post hoc analysis of the AVERT trial (NCT01142726), in which several potential factors were assessed, erosions, synovitis and bone oedema scores on MRI and HAQ-DI scores in patients with DAS28 (CRP) Objectives To evaluate post hoc the association between different thresholds of MRI and HAQ-DI scores at Month 12 and the risk of relapse at Months 18 and 24 in AVERT. Methods This analysis compared relapse event rates at Months 18 and 24 in patients with DAS28 (CRP) 3 for synovitis,>2 for bone oedema,>7 for (weighted) combined synovitis and bone oedema,>5 for erosion and >0.5 for HAQ-DI. Univariate logistic models were conducted for comparisons and odds ratios (OR) with 95% CI and associated p values. Results All randomised and treated patients with DAS28 (CRP) 3), 28 (18.1%) had a higher bone oedema score (>2), 39 (25.2%) had a higher combined score (>7), 73 (47.1%) had a higher erosion score (>5) and 42 (27.1%) had a higher HAQ-DI score (>0.5). Relapse events at Months 18 and 24 were significantly associated with supra-threshold MRI bone oedema, erosion and combined scores and with supra-threshold HAQ-DI score at Month 12 (figure 1). There was a trend toward association of relapse at Months 18 and 24 with high synovitis score (figure 1). Conclusions It was possible to define MRI and HAQ-DI scores in patients with DAS28 (CRP) remission that were predictive of relapse 6 and 12 months after complete drug withdrawal in AVERT. Assessment of imaging and physical function, using predefined thresholds, in patients achieving remission may aid clinical decisions on when to withdraw therapy in MTX-naive patients with RA. References [1] Emery P, et al. Ann Rheum Dis2015;74:19–26. [2] Ahmad H, et al. Ann Rheum Dis2017;76(suppl 2):240. Disclosure of Interest H. Ahmad Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, J. Baker: None declared, M. Ostergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Janssen, Merck, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Centocor, GSK, Hospira, Janssen, Merck, Mundipharma, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Schering-Plough, Roche, Takeda, UCB, Wyeth, P. Emery Consultant for: AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Roche, Lilly, Novartis, Samsung Bioepis, T. Huizinga Grant/research support from: EU and Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Novartis, Pfizer, Roche, sanofi-aventis, Schering-Plough, UCB, Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, Y. Elbez Consultant for: Bristol-Myers Squibb, S. Banerjee Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, P. Conaghan Grant/research support from: Bristol-Myers Squibb, Consultant for: AbbVie, GSK, Lilly, Novartis, Pfizer, Roche, Speakers bureau: AbbVie, Bristol-Myers Squibb, Novartis

Background Patients (pts) with early RA often present with multiple areas of involvement. Limited data exist to identify which specific joints or joint locations may be indicative of poorer prognosis and require more intensive initial therapy. 1 Objectives This analysis investigated which joint locations have the poorest prognosis and compared clinical response rates between abatacept (ABA)+MTX and MTX monotherapy by baseline (BL) swollen joint status for specific joint locations. Methods Data from AGREE (NCT00122382), a double-blind Phase III study of ABA+MTX (n=256) vs MTX (n=253) in biologic-naive pts with early (≤2 years [yrs]) erosive RA, were analysed by BL swollen joint status (present, absent) for 8 different joint locations: hands, wrists, elbows, shoulders, jaw, knees, ankles and feet. Overall characteristics and study results were reported previously. 2 Swelling was evaluated at BL and after 6 months (mths) of treatment. Differences between treatment groups in clinical response endpoints (i.e. DAS28 [CRP] Results In an early RA cohort of pts at risk of active, rapidly progressing disease, the proportions of pts (n=509) with a swollen joint at BL were 99% hand, 92% wrist, 79% ankle, 69% knee, 66% foot, 48% elbow, 34% shoulder and 9% jaw. Pts with a swollen jaw (n=45) had more tender joints (mean [SD] 40.0 [15.1] vs 30.1 [14.1]), more swollen joints (35.9 [13.3] vs 21.1 [9.5]), higher total Sharp score (9.4 [10.1] vs 6.9 [9.1]) and longer disease duration (11.7 [9.2] yrs vs 6.0 [6.9] yrs) than those without jaw swelling (n=464). Higher HAQ-DI was seen in pts with a swollen knee or shoulder (1.8 [0.6] vs 1.5 [0.7] and 1.9 [0.6] vs 1.6 [0.7], respectively). Presence of BL synovitis was not associated with greater BL anti-citrullinated protein antibodies or RF positivity, probably due to the inclusion of mainly seropositive pts. In general, absence of BL swelling was associated with higher clinical response at 6 mths, both for ABA+MTX and MTX. Independent of BL swollen joint status, ABA+MTX had higher clinical response rates (DAS28, SDAI, CDAI, Boolean and HAQ remission) than MTX, except for the non-swollen wrist. Overall mean Boolean remission rates were 13.7% for ABA+MTX vs 5.5% for MTX with difference in proportions (95% CI) of 8.1% (2.6, 13.7) (p=0.003). The largest difference in Boolean remission rate (95% CI) favouring ABA+MTX was 9.6% (4.2, 15.1) (p Conclusions BL swelling in the shoulder, knee and jaw is associated with a more severe RA profile. Remission rates were higher with ABA+MTX than MTX when BL swelling was present, especially in the wrist. Also, swollen joint resolution was more pronounced with ABA+MTX, especially in the hands. References [1] Bergstra SA, et al. RMD Open2017;3:e000568. [2] Westhovens R, et al. Ann Rheum Dis2009;68:1870–7. Disclosure of Interest P. Durez Speakers bureau: Bristol-Myers Squibb, Eli Lilly, Sanofi, S. Robert Employee of: Bristol-Myers Squibb, A. Thiry Employee of: Bristol-Myers Squibb, H. Ahmad Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb

Background Binary cut-offs for disease activity are frequently used in clinical decision-making for patients with RA because they are accurate reflections of disease activity, discriminate well between disease acvitiy states and are feasible to perform in routine clinical practice.1 Results from a previous post hoc analysis of the randomized, controlled, head-to-head AMPLE trial (NCT00929864) indicated a trend for increased efficacy, as assessed using DAS28 (CRP), for abatacept (ABA) compared with the TNF inhibitor adalimumab (ADA) in patients with seropositive, erosive early RA.2,3 Objectives To evaluate post hoc the impact of treatment with either SC ABA or ADA on sustained validated definitions of remission and DAS28 (CRP) Methods This post hoc analysis of the AMPLE trial builds on previous work3 to compare clinical outcomes between treatment groups in two subsets: patients with disease duration ≤6 months, RF or anti-citrullinated protein antibody seropositivity and >1 radiographic erosion (Cohort 1), and patients in whom ≥1 of these inclusion criteria were absent (Cohort 2). Disease activity and patient-reported outcomes were evaluated at Weeks 26, 52 and 104. Endpoints were defined as percentages of patients with DAS28 (CRP) Results Of 646 randomized patients, 83 were included in Cohort 1 (ABA, n=38; ADA, n=45) and 563 in Cohort 2 (ABA, n=280; ADA, n=283). At Week 52, significantly more ABA- than ADA-treated patients achieved DAS28 (CRP) Conclusions This post hoc analysis indicates a trend towards increased efficacy for abatacept compared with adalimumab on measures of sustained remission and DAS28 (CRP) References: [1] Anderson J, et al. Arthritis Care Res (Hoboken) 2012;64:640-7. [2] Schiff M, et al. Ann Rheum Dis 2014;73:86-94. [3] Fleischmann R, et al. EULAR 2017; poster SAT0041. [4] Harrold LR, et al. J Rheumatol 2018;45:32-9. [5] Emery P, et al. Ann Rheum Dis 2015;74:19-26. Disclosure of Interest: R. FleischmannGrant/research support from: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, EMD-Serono, Eli Lilly, Merck, Novartis, Pfizer, Roche, Sanofi-Genzyme, UCB, Consultant for: AbbVie, ACEA, Amgen, Bristol-Myers Squibb, GSK, Eli Lilly, Novartis, Pfizer, Sanofi-Genzyme, UCB, M. Weinblatt Grant/research support from: Bristol-Myers Squibb, Amgen, Crescendo Bioscience, Sanofi, Consultant for: Bristol-Myers Squibb, Amgen, Crescendo Bioscience, AbbVie, Eli Lilly, Pfizer, Roche, Merck, Samsung, Novartis, H. Ahmad Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, M. Maldonado Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, E. Alemao Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Y. Elbez Consultant for: Bristol-Myers Squibb, M. Schiff Consultant for: Abbvie, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb

Background Factors predictive of relapse need to be identified to aid therapy withdrawal decisions for patients with RA achieving remission with treatment. AVERT (NCT01142726) was a Phase IIIb, randomized, active-controlled trial in patients with early RA. 1 After a 12-month, double-blind treatment period with abatacept + MTX, or abatacept or MTX monotherapy, patients with DAS28 [CRP] Objectives To evaluate post hoc whether MRI scores, patient characteristics and disease activity at Month 12 were predictors of clinical relapse at Month 18 and Month 24 after treatment withdrawal in AVERT. Methods Synovitis, erosion and bone oedema in the dominant hand and wrist MRI were scored at Month 12 using the RA MRI scoring system (RAMRIS). Patient characteristics (pain, age, weight, HAQ-DI) and disease measures (CRP, SJC28, TJC28, DAS28 [CRP], CDAI, SDAI) were recorded at Month 12. The influence of these factors on the proportion of patients who relapsed (doubling of TJC28 and SJC28, and DAS28 [CRP] ≥1.2 increase relative to Month 12) by Month 18 and Month 24 was assessed. Results A total of 172 patients achieving DAS28 remission (DAS28 [CRP] Conclusions MRI and HAQ-DI scores in patients in DAS28 remission predicted clinical relapses 6 and 12 months after complete drug withdrawal in the AVERT trial. The clinical decision on whether to withdraw therapy in MTX-naive patients with RA in remission may benefit from an assessment of imaging and physical function prior to drug withdrawal. References Emery P, et al. Ann Rheum Dis 2015;74:19–26. Disclosure of Interest H. Ahmad Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, J. Baker: None declared, M. Ostergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Janssen, Merck, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Centocor, GSK, Hospira, Janssen, Merck, Mundipharma, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Schering-Plough, Roche, Takeda, UCB, Wyeth, P. Emery Grant/research support from: AbbVie, Merck, Pfizer, Roche, Consultant for: AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Roche, Lilly, Novartis, Samsung Bioepis, T. Huizinga Grant/research support from: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Biosciences, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, J. Ye Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, S. Banerjee Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, P. Conaghan Grant/research support from: Bristol-Myers Squibb, Consultant for: AbbVie, Lilly, Novartis, Pfizer, Speakers bureau: AbbVie, Bristol-Myers Squibb, Roche

Background Clinicians rely on time-efficient, validated disease activity assessments to help predict disease progression accurately in patients (pts) with RA. The utility in predicting structural damage progression for the Routine Assessment of Patient Index Data 3 (RAPID3) 1 is largely unknown, while that of DAS28 (CRP) 2 and modified (M-)DAS28 have been previously reported. 3 Objectives This post hoc analysis examined the relationship between baseline disease activity measures and their ability to predict structural damage progression in the Phase III AMPLE (NCT00929864) trial. 4 Methods AMPLE was a randomized, investigator-blinded study in which MTX-experienced pts with active RA ≤5 years received SC abatacept 125 mg weekly or adalimumab 40 mg every 2 weeks in combination with stable-dose MTX. Logistic regression analysis was used to correlate the effect of disease activity at baseline on radiographic (X-ray) progression at Months (M) 12 and 24. Disease activity was assessed using M-DAS28, 3 DAS28 (CRP), RAPID3, CDAI and SDAI. Radiographs were scored using the modified Sharp/van der Heijde scoring system; progression was defined as change from baseline in total score greater than the smallest detectable change, which was calculated as SD/square root (2) x 1.96 (where SD is standard deviation of paired differences of change from baseline in total score between two readers). Results Logistic regression analysis was carried out for all randomized and treated pts (abatacept, n=318; adalimumab, n=328). For these patients, M-DAS28, DAS28 (CRP) and RAPID3 at baseline were significant predictors of radiographic progression at M12 and M24, baseline SDAI was a significant predictor at M12 but not M24 and baseline CDAI was not a significant predictor at either time point (Table). Receiver operating characteristic curves showed that M-DAS28, DAS28 (CRP) and RAPID3 had higher predictive value (area under the curve) than CDAI or SDAI for radiographic progression at M12 and M24 (Table). There was no impact of treatment arm on predictors of radiographic outcomes. Conclusions In this post hoc analysis, disease activity scores at baseline according to M-DAS28, DAS28 (CRP) and RAPID3 were good predictors of radiographic progression at M12 and M24 and were more predictive than other measures of disease activity tested, with M-DAS28 demonstrating the greatest degree of prediction. References Yazici Y, et al. J Rheumatol 2008;35:603–9. Salaffi F, et al. BMC Musculoskelet Disord 2011;12:120. Baker JF, et al. Arthritis Rheumatol 2014;66:794–802. Schiff M, et al. Ann Rheum Dis 2014;73:86–94. Disclosure of Interest E. Keystone Grant/research support from: Abbott, Amgen, AstraZeneca, Bristol-Myers Squibb, F. Hoffmann-La Roche, Janssen, Lilly, Novartis, Pfizer, sanofi-aventis, UCB, Consultant for: Abbott, AstraZeneca, Biotest, Bristol-Myers Squibb, Crescendo, F. Hoffmann-La Roche, Genentech, Janssen, Lilly, Merck, Pfizer, UCB, Speakers bureau: Amgen, Abbott, AstraZeneca, Bristol-Myers Squibb, F. Hoffmann-La Roche, Janssen, Pfizer, Sanofi, Genzyme, UCB, H. Ahmad Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, Y. Yazici Grant/research support from: Genentech, Celgene, Bristol-Myers Squibb, Consultant for: Genentech, Celgene, Bristol-Myers Squibb, E. Muratti Employee of: Bristol-Myers Squibb, J. Ye Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, M. Bergman Shareholder of: Pfizer, Johnson & Johnson, Consultant for: AbbVie, Bristol-Myers Squibb, Amgen, Celgene, Genentech, Pfizer, Janssen, Speakers bureau: Norvatis, Abbvie, Celegene

Background In the Phase III ASTRAEA study (NCT01860976), abatacept (ABA) significantly increased ACR20 responses, with benefits on other musculoskeletal symptoms in patients (pts) with active psoriatic arthritis (PsA). 1 As PsA impacts HRQoL, assessing treatment (tmt) effect using patient-reported outcomes (PROs) is important. Objectives To explore the effect of ABA tmt using PROs in intent-to-treat and post hoc analyses of ASTRAEA. Methods Pts were randomized (1:1) to SC ABA 125 mg weekly or placebo (PBO) for 24 weeks (W). At W16, pts without ≥20% improvement in joint counts started open-label ABA. Adjusted mean changes from baseline (BL) to W16 (all pts) and W24 (responder analysis) in Short Form-36 (SF-36; physical and mental component summary [PCS, MCS] and individual domains using spydergrams), pain VAS and HAQ-DI scores, Dermatology QoL Index (DLQI) and FACIT-Fatigue scale (FACIT-F) were evaluated in the total population and subgroups stratified by BL CRP level and prior TNFi use. Proportions of pts reporting improvements ≥minimal clinically important difference (MCID) in SF-36 summary (≥2.5) and domain (≥5.0), FACIT-F (≥40) and HAQ-DI ( Results In the total population, improvements in all PROs were numerically greater for ABA (n=213) vs PBO (n=211) at W16 and W24 and significant for SF-36 PCS at W16 and HAQ-DI at W24 (Table). At W16, improvements in all SF-36 domains were numerically greater with ABA, and significant for physical function, bodily pain and vitality. A higher proportion of pts receiving ABA vs PBO reported improvements ≥MCID in SF-36 PCS, MCS, SF-36 domains, FACIT-F, HAQ-DI (Fig) and DLQI (not shown) at W16. The proportion of pts whose scores were ≥normative values at W16 was higher with ABA vs PBO in SF-36 PCS, MCS, FACIT-F and HAQ-DI scores. At W24, improvements in SF-36 domain scores accrued in both groups, with numerical differences in favour of ABA except in social function. Improvements in PROs were greater with ABA tmt in BL CRP>upper limit of normal (ULN) vs CRP≤ULN and in TNFi-naive vs -exposed subpopulations. Conclusions Abatacept treatment improved many PROs in pts with active PsA, with larger benefits in the CRP>ULN and TNF-naive subpopulations. References Mease P, et al. Arthritis Rheumatol 2016;68(suppl 10): [Abstract 1041]. Disclosure of Interest V. Strand Consultant for: AbbVie, Amgen Corporation, AstraZeneca, Biogen Idec, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, Corrona, Crescendo/Myriad Genetics, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, UCB, E. Alemao Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, T. Lehman Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, A. Johnsen Employee of: Bristol-Myers Squibb, S. Banerjee Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, H. Ahmad Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, P. Mease Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo Bioscience, Genentech, Janssen, Novartis, Pfizer, UCB

Background Abatacept, a selective T-cell co-stimulation modulator, significantly increased ACR20 response and had an overall beneficial effect on musculoskeletal symptoms in patients (pts) with active psoriatic arthritis (PsA) in the Phase III Active pSoriaTic athritis RAndomizEd triAl (ASTRAEA, NCT01860976). 1 Factors that may predict responses to abatacept were explored in this post hoc analysis. Objectives To evaluate the relationship between baseline characteristics and abatacept response in a post hoc analysis of ASTRAEA. Methods Pts were randomized (1:1) to SC abatacept 125 mg weekly or placebo for 24 weeks in this trial. Pts without >20% improvement in joint counts at Week 16 were switched to open-label abatacept (early escape). ACR20 response rate in pts stratified by baseline variables was investigated in a multivariate analysis and odds ratios (ORs) generated to identify differences in response. Using a cut-off of OR 1.2, indicating pt subgroups in whom abatacept appeared to have a meaningful treatment benefit, baseline variables were further investigated in a univariate analysis and estimated differences calculated. Results Of 424 pts enrolled, 213 received abatacept and 211 placebo. In abatacept-treated pts, the multivariate model showed a difference in ACR20 response (OR >1.2) for baseline CRP (>upper limit of normal [ULN] vs ≤ULN; OR 1.346 [95% CI 0.668, 2.712]), DAS28 (CRP) (>5.1 vs ≤5.1; 1.489 [0.782, 2.836]), dactylitis (>0 vs 0; 1.372 [0.708, 2.659]), and median baseline erosions (≥3 vs 1.2 for dactylitis only (1.406 [0.619, 3.193]). These factors, which have been identified previously as indicating poor prognosis in PsA, were balanced between treatment arms at baseline. In the univariate model by poor prognostic factors, the differences in ACR20 response rates with abatacept treatment vs placebo in distinct subgroups were numerically greater in pts who were positive for these prognostic factors at baseline than in those who were not (Figure). Conclusions These findings identified subgroups of pts with PsA with certain baseline characteristics in whom abatacept is most likely to be effective. The predictive factors identified are aligned with poor prognostic factors in the EULAR and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) guidelines, 2,3 and may indicate pts with the highest unmet medical need. References Mease P, et al. Arthritis Rheumatol 2016;68(Suppl 10):[Abstract 1041]. Gossec L, et al. Ann Rheum Dis 2016;75:499–510. Coates L, et al. Arthritis Rheumatol 2016;68:1060–71. Disclosure of Interest P. Mease Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo Biosciences, Corrona, Demira, Janssen, Lilly, Novartis, Pfizer, Sun, UCB, Zynerba, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Crescendo Biosciences, Genentech, Janssen, Novartis, Pfizer, UCB, I. McInnes Grant/research support from: Bristol-Myers Squibb, Celgene, Janssen, UCB, Consultant for: Bristol-Myers Squibb, Celgene, Janssen, Novartis, Pfizer, AbbVie, UCB, V. Strand Consultant for: AbbVie, Amgen Corporation, AstraZeneca, Biogen Idec, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Celltrion, Corrona, Crescendo Biosciences/Myriad Genetics, EMD Serono, Genentech/Roche, GlaxoSmithKline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, UCB, O. FitzGerald Grant/research support from: AbbVie, Pfizer, Bristol-Myers Squibb, Consultant for: AbbVie, Pfizer, Bristol-Myers Squibb, Celgene, Janssen, Novartis, UCB, Lilly, H. Ahmad Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, A. Johnsen Employee of: Bristol-Myers Squibb, Celgene, Janssen, Novartis, Pfizer, AbbVie, UCB, J. Ye Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, S. Banerjee Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb

Background Patients (pts) who are anti-citrullinated protein antibody (ACPA) positive tend to develop more severe erosive disease than ACPA-negative pts.1 The presence of seropositivity and erosions have been noted in EULAR treatment guidelines as poor prognostic factors to identify pts with RA who require early and aggressive clinical intervention.2 Since the disease in pts with seropositive, erosive early RA is mostly driven by immunological features, response to RA therapy may vary based on therapeutic mechanism of action (MOA). Objectives To investigate the efficacy of abatacept (ABA) vs adalimumab (ADA) in pts with seropositive, erosive early RA. Methods AMPLE (NCT00929864)3 was a 2-year, Phase IIIb study in which biologic-naive pts with RA were randomized 1:1 to either SC ABA 125 mg weekly or SC ADA 40 mg biweekly, both with background MTX. This post hoc analysis of AMPLE compared clinical outcomes between treatment groups in a subpopulation of pts with specified baseline criteria: disease duration ≤6 months, RF or ACPA seropositivity and >1 radiographic erosion. Disease activity and patient-reported outcomes were evaluated at Weeks 26, 52 and 104. Endpoints were compared between ABA and ADA groups using chi-square test for categorical variables, analysis of covariance model (ANCOVA) controlling for baseline covariates and DAS28 (CRP) stratification for continuous variables. Results Of 318 and 328 pts in the ABA and ADA groups, respectively, 38 and 45 pts had all specified baseline characteristics (Cohort 1) and 280 and 283 pts had an absence of at least 1 of the specified characteristics (Cohort 2). Overall, the baseline characteristics, including anti-cyclic citrullinated peptide titres, were well balanced between the groups, with the exception of weight. For Cohort 1, adjusted mean change (95% CI) from baseline DAS28 (CRP) with ABA vs ADA was –2.18 (–2.61, –1.75) vs –1.56 (–2.01, –1.11) at Week 26, –2.58 (–2.99, –2.17) vs –1.68 (–2.10, –1.25) at Week 52 and –2.50 (–2.97, –2.03) vs –2.0 (–2.49, –1.50) at Week 104. Similar trends of increased efficacy with ABA vs ADA were observed for changes from baseline CDAI, SDAI, HAQ-DI, pain and fatigue; no differences in radiographic progression were observed. For Cohort 2, no differences in clinical outcomes between ABA and ADA groups were observed. Given the differences in baseline weight between ABA and ADA groups in Cohort 1, sensitivity analyses that excluded pts >100 kg and adjusted for baseline weight were performed and demonstrated minimal effect of weight on treatment efficacy. Conclusions This post hoc analysis seems to indicate a trend of increased efficacy for abatacept in pts with seropositive, erosive early RA compared with the TNF inhibitor adalimumab. Given the small sample size, additional pre-specified randomized studies are needed to compare the benefit of biologic DMARDs with different MOAs in pts with early, rapidly progressing RA. References Combe B, et al. Ann Rheum Dis 2016 Dec 15. doi: 10.1136/annrheumdis-2016–210602. Aletaha D, et al. Arthritis Rheum 2010;62:2569–81. Weinblatt M, et al. Arthritis Rheum 2013;65:28–38. Disclosure of Interest R. Fleischmann Grant/research support from: AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Roche, sanofi-aventis, UCB, Consultant for: AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Pfizer, Roche, sanofi-aventis, UCB, M. Weinblatt Grant/research support from: Amgen, Bristol-Myers Squibb, Crescendo Bioscience, UCB, DxTerity, Consultant for: Amgen, Bristol-Myers Squibb, Crescendo Bioscience, UCB, AbbVie, Lilly, Pfizer, Roche, H. Ahmad Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, M. Maldonado Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, E. Alemao Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, J. Ye Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, M. Schiff Consultant for: AbbVie, Bristol-Myers Squibb, Eli Lilly, JNJ, UCB, Speakers bureau: AbbVie

Background Patients with RA who are at a higher risk for progressive and destructive arthritis could be identified using anti-cyclic citrullinated peptide (anti-CCP) levels. 1 Treatment guidelines recommend the use of non-biologic DMARDs as initial treatment in RA; but, if warranted, biologic (b)DMARDs could be considered in early treatment of RA. 2 Real-world data describing treatment patterns based on anti-CCP designations are limited. Objectives This study evaluated treatment patterns of patients with RA who are anti-CCP positive (+) or negative (–). Methods This retrospective study was based on electronic medical record (EMR) data with a supplemental chart review from a large integrated delivery system. Patients newly diagnosed with RA (International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code 714.0x) were identified between 1 January 2009 and 31 December 2014. The first RA diagnosis date was designated as the index date. Patients were required to have 12 months of continuous activity in the EMR (6 months pre- and 6 months post-index). Based on the baseline anti-CCP test results, patients were categorized as anti-CCP+ (≥7.0 U) or anti-CCP– ( Results Overall, 217 anti-CCP+ and 191 anti-CCP– patients with RA were included in this study. A higher proportion of anti-CCP+ (153, 70.5%) than anti-CCP– patients (44, 23.0%; p Conclusions After diagnosis of RA, patients who are anti-CCP+ were more likely to start therapy, indicating that physicians were more aggressive in treating this cohort. Patients were treated according to guidelines with non-biologic DMARDs, predominantly MTX. Patterns of treatment change differed between the cohorts; however, treatment response was similar with a complete response rate of 20%. References Singh JA, et al. Arthritis Rheumatol 2016;68:1–26. Niewold TB, et al. QJM 2007;100:193–201. Disclosure of Interest K. Price Employee of: Bristol-Myers Squibb, Y. Doleh Employee of: Bristol-Myers Squibb, M. Eaddy Consultant for: Xcenda, A. Ogbonnaya Employee of: Xcenda, H.-C. Shih Employee of: Xcenda, H. Ahmad Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, L. Lamerato Grant/research support from: Centers for Disease Control, National Cancer Institute, Policy Analysis, Inc, Outcomes Research Solutions, Xcenda, eMAXHealth, Merck Pharmaceuticals, Pfizer Pharmaceuticals, Reagan Udall Foundation, AstraZeneca, Employee of: Henry Ford Health System, University of Michigan-Dearborn, A. Szymialis Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb