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Background:Enthesitis is a recommended core domain for assessment of ankylosing spondylitis (AS), but no measurement has yet been validated according to Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) criteria.Objective:The purpose of this study was to seek to validate an enthesitis index for patients with AS according to OMERACT criteria.Methods:An enthesitis index was validated in two AS patient cohorts: (1) a longitudinal cohort (n = 223) and (2) 22 patients from three Canadian sites participating in a 24-week randomised placebo-controlled trial of adalimumab in AS. Construct validity was evaluated by correlation analysis with the Bath AS Disease Activity Index (BASDAI), the Bath AS Functional Index (BASFI) and quality of life instruments. Reproducibility was assessed by intraclass correlation coefficient (ICC), and responsiveness was assessed by Guyatt’s effect size and standardised response mean.Results:The most frequently affected sites were the greater trochanter and supraspinatus insertion (∼20%). Patients with enthesitis had significantly greater scores for the BASDAI, BASFI, patient global, AS-specific quality of life index (ASQOL) and the Short Form 36 (SF-36) General Health Survey (p<0.001). The enthesitis score contributed significantly to variance in the BASDAI and BASFI. Interobserver ICCs were 0.96 in the longitudinal cohort and 0.89 and 0.77 in the adalimumab clinical trial cohort (for status and change score, respectively). Significant differences in change scores were evident for all patients after 24 weeks of adalimumab treatment, (p = 0.04), this being more significant when a subset of the most commonly affected entheses were analysed (p = 0.01).Conclusion:AS patients with enthesitis constitute a more severe subset of disease, and the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index is feasible and reliable for measurement of this condition. Discrimination requires further study in larger trials.

Background:While analysis of disease severity at specific time points is informative, the trajectory of rheumatic arthritis (RA) treatment response over time may be more relevant. Identification of predictors of different RA disease trajectory patterns may be useful for clinical decision-making.Objectives:To describe the 12-month clinical disease activity index (CDAI) trajectory patterns and identify determinants of rapid trajectory in patients (pts) treated for RA with abatacept.Methods:This was a post hoc analysis of 290 adult RA pts who were initiated on treatment with abatacept in the Abatacept Best Care (ABC) study (NCT03274141)1. A growth mixture model (GMM) identified CDAI trajectory groups over 12 months. Bivariate analyses identified potential predictors of trajectories among baseline patient and disease characteristics. Variables with an important difference (P<0.15) were included in full multivariate logistic model. Stepwise selection was used to determine the final logistic model.Results:The GMM identified rapid responders (RR: n = 210 [72.4%]) with sustained decline in CDAI by 3 months, non-rapid responders (NRR: n = 75 [25.9%]) and non-classifiable (NC: n = 5 [1.7%]). NC pts were excluded from the final analysis. For the overall analysis population (n = 285), mean (SD) age was 60.2 (11.7) years and 75 (26.3%) were male without differences between response groups. Table 1 describes the significant between-group differences on bivariate analyses.Table 1.In multivariate analysis, shorter disease duration and lower comorbidity index, TJC, patient pain, and fatigue at baseline were significant independent predictors of having a rapid CDAI response trajectory over 12 months (Table 2).Table 2.Conclusion:In this real-world study, the majority of RA pts treated with abatacept showed a rapid trajectory in clinical improvement. Shorter disease duration, fewer comorbidities, and lower patient-driven outcomes (TJC, pain, fatigue) at baseline, but not physician-reported measures, were identified as predictors of rapid response. Trajectory-based analyses may have implications for clinical practice and research by informing therapeutic expectations.REFERENCES:[1] Bessette, L. et al. Effectiveness of a treat-to-target strategy in patients with moderate to severely active rheumatoid arthritis treated with abatacept. Arthritis Res Ther 25, 183 (2023). https://doi.org:10.1186/s13075-023-03151-2Acknowledgements:NIL.Disclosure of Interests:Louis Bessette speaker for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Lilly, Novartis, Sanofi, Sandoz, Fresenius Kabi, Teva, Organon and JAMP Pharma, consultant for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Lilly, Novartis, Sanofi, Sandoz, Fresenius Kabi, Teva, Organon and JAMP Pharma, research support from Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Celgene, Sanofi, Lilly, Novartis, Gilead and JAMP Pharma, John Sampalis employee of JSS Medical Research, the contract research organization that managed the study, Boulos Haraoui advisory board member and research grants from Abbvie, Amgen, BMS, Fresenius Kabi, Lilly, Pfizer and UCB, Emmanouil Rampakakis employee of JSS Medical Research, the contract research organization that managed the study, Dylan Keating employee of JSS Medical Research, the contract research organization that managed the study, Marc Olivier Trepanier employee of Bristol Myers Squibb and may hold stock or stock options, employee of Bristol Myers Squibb and may hold stock or stock options, Janet Pope consultant for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Gilead, Janssen, Medexus, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi, Teva and UCB, grant/research support from AbbVie, Bristol Myers Squibb, MSD, Pfizer, Roche, Seattle Genetics and UCB.

Background:Rheumatoid arthritis (RA) has a major impact on patients (pts), particularly around quality of life and activity impairment. While the association between clinical manifestations and patient-reported outcomes (PROs) has been demonstrated, the independent effect of specific joint involvement on PROs and their change over time has not been fully elucidated.Objectives:To describe the independent effect of overall and specific joint involvement and their changes over time on PROs in pts with RA treated with abatacept.Methods:This post hoc analysis involved 290 adult RA pts initiated on treatment with abatacept in the Abatacept Best Care (ABC) study (NCT03274141)1. The analysis investigated the association of Tender Joint Count (TJC-28), Swollen Joint Count (SJC-28) and involvement (tender and/or swollen) of five joint groups (shoulder, knee, elbow, wrist, and hand) with changes from baseline (BL) to 12 months (12M) of follow-up in selected PROs: Pt Global Assessment (PtGA), Pt Pain, Pt Fatigue, Health Assessment Questionnaire-Disability Index (HAQ-DI), Routine Assessment of Patient Index Data 3 (RAPID3), Work Productivity and Activity Impairment - Activity Impairment (WPAI-AI) score. Simple linear regression was used to test the association between BL and changes from BL to 12M in TJC and SJC with changes in each PRO at 12M. Multivariate linear regression adjusting for the five available joint groups examined the independent effect of BL and changes from BL to 12M in these joint groups on changes in each PRO at 12M.Results:Among 290 pts, the mean (SD) age was 60.1 (11.6) years, 73.8% were female, and the mean (SD) RA duration was 7.7 (9.0) years. Table 1 describes joint involvement (tender and/or swollen) at BL and the change from BL to 12M for 289 pts with 12M data.Mean (SD) TJC and SJC at BL were 9.6 (6.2) and 7.9 (4.7) and changes in TJC and SJC from BL to 12M were -6.3 (6.6) and -5.9 (5.2), respectively. BL TJC and SJC were not associated with changes in PROs from BL to 12M, whereas changes at 12M in TJC and SJC were significantly (P<0.05) associated with changes in all PROs.Table 2 summarizes the significant (P<0.05) independent associations between BL or change in involvement (tender and/or swollen) of the five available joint groups from BL to 12M with changes in PROs at 12M. Change in hand involvement was significantly associated with changes in all PROs. After adjusting for all available joint groups, changes in elbow, hand, and knee involvement showed the greatest impact on patient function and activity impairment. Elbow was the only joint whose BL involvement was associated with significantly greater improvements in Pt Pain, PtGA, and functional status through 12M.Conclusion:For the majority of pts, specific joint involvement at BL was resolved by 12M of treatment with abatacept. Changes in PROs at 12M were associated with BL elbow involvement and 12M changes in elbow, hand, and knee involvement. These findings have potential implications for clinical practice and research by guiding the focus of evaluations and therapeutic targets.REFERENCES:[1] Bessette, L. et al. Effectiveness of a treat-to-target strategy in patients with moderate to severely active rheumatoid arthritis treated with abatacept. Arthritis Res Ther 25, 183 (2023). https://doi.org:10.1186/s13075-023-03151-2Acknowledgements:NIL.Disclosure of Interests:Janet Pope consultant: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Gilead, Janssen, Medexus, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi, Teva and UCB, grant/research support: AbbVie, Bristol Myers Squibb, MSD, Pfizer, Roche, Seattle Genetics and UCB, John Sampalis employee of JSS Medical Research, the contract research organization that managed the study, Boulos Haraoui advisory board member and research grants from Abbvie, Amgen, BMS, Fresenius Kabi, Lilly, Pfizer and UCB, Emmanouil Rampakakis employee of JSS Medical Research, the contract research organization that managed the study, Fiona Allum employee of JSS Medical Research, the contract research organization that managed the study, Marc Olivier Trepanier Employee of Bristol Myers Squibb and may hold stock or stock options, Employee of Bristol Myers Squibb, Louis Bessette speaker for Amgen, BMS, Janssen, UCB, AbbVie, Pfizer, Lilly, Novartis, Sanofi, Sandoz, Fresenius Kabi, Teva, Organon and JAMP Pharma, consultant for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Gilead, Janssen, Medexus, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi, Teva and UCB.

The efficacy, safety and disease-modification of tramiprosate (homotaurine)were investigated in a recently completed large-scale Phase III clinical study in patients with mild to moderate Alzheimer's disease (AD), the Alphase study. Disease-modification was assessed using longitudinal volumetric MRI (vMRI) measurements of the hippocampus in a subgroup of patients. The present study describes the vMRI, cognitive and clinical results obtained in this subgroup. Multi-center, double-blind, randomized, placebocontrolled study in a subset of the 1052 patients of the Alphase study. 51 vMRI investigative sites in the United States and Canada. A total of 508 patients underwent vMRI scanning. Of these, 312 provided scan pairs for assessing hippocampus volume changes and were included in the analyses. Patients were randomized to receive Placebo BID (n = 109), tramiprosate 100 mg BID (n = 103), or tramiprosate 150 mg BID (n = 100) for 78 weeks. Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and Clinical Dementia Rating-Sum-of-boxes CDR-SB assessments were conducted at Baseline and at Weeks 13, 26, 39, 52, 65 and 78. Exploratory analyses were performed using similar First and Final mixed-effects repeated-measures models that were used for the analysis of the entire patient dataset. Psychometric score results showed numerical trends in favour of tramiprosate that did not reach statistical significance. While there were no statistically significant group differences in hippocampus volume using the First modeling approach, a significant dose-response reduction in hippocampus volume change was found in the Final models. Moreover, there was a marginally significant overall treatment main effect and a significant slope difference in favour of tramiprosate according to the Final model analysis of the ADAS-cog scores. ADAS-cog scores analyzed according to this model also revealed differences in favor of the tramiprosate 150 mg group at weeks 26 and 52, with marginally significant differences at Weeks 13 and 39. Slope analyses of ADAS-cog score changes showed significant differences in favor of the 150 mg BID group, and when both active groups were combined, in comparison to the placebo group. No between-group differences with respect to changes to each visit in the CDR-SB were observed with either modeling approach. Although there was a similar dose-response relationship observed in the hippocampus volume and ADAS-cog Final model analyses, the overall changes in psychometric scores and hippocampus volume were not significantly correlated. Exploratory analysis of the vMRI subgroup suggests that tramiprosate slows hippocampal atrophy, and reveals some evidence of a beneficial effect on cognition. The clinical validity of the vMRI biomarker is discussed.

To determine whether the fibula free flap is the most frequently used osteocutaneous flap for mandible reconstruction, and whether it provides quality of life, depression and anxiety advantages. A systematic review of the public Medline database was conducted. Thirteen patients who underwent mandibular reconstruction at our hospital centre completed questionnaires to evaluate quality of life, depression and anxiety outcomes. The most frequently used free flaps are those of the fibula (n = 982), radial forearm (n = 201), iliac crest (n = 113), subscapular system (n = 50) and rib-serratus (n = 7). In our patient population, there was a trend towards a better quality of life in those with a fibula free flap. However, patients in this group were significantly younger than patients with other flap types (p = 0.025). Patients with a subscapular system free flap were more depressed (p = 0.031); however, they had large through-and-through defects. The flap used most frequently in the literature is the fibula free flap. Comparative quality of life data are lacking, and homogeneous populations should be used to reach significant conclusions.

Tramiprosate (homotaurine, ALZHEMED™) was recently investigated for its efficacy, safety and disease-modification effects in a Phase III clinical study in mild to moderate Alzheimer's disease (AD) patients (the Alphase study). The primary cognitive endpoint measure of that study was the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog). To characterize potential cognitive benefits of tramiprosate, the present study describes exploratory analyses performed on scores obtained from the specific ADAS-cog subscales in order to determine whether specific domains of cognition may be differentially affected by tramiprosate, which would not have been evident from the measure's total score. Multi-center, double-blind, randomized, placebo-controlled study. 67 investigative sites in the United States and Canada. A total of 1,052 patients were randomized. Interventions: Patients were randomized to receive twice a day Placebo (n=353), tramiprosate 100 mg (n=352) and tramiprosate 150 mg (n=347). ADAS-cog assessments were conducted every three months over the 78-week study period. Exploratory analyses were performed by comparing ADAS-cog subscale scores between Placebo and each active treatment arm at each visit. The findings of this analysis revealed statistically significant differences or statistical trends in favour of tramiprosate on six ADAS-cog subscales, namely Following Commands, Language Comprehension, Ideational Praxis, Object Naming, Remembering Test Instructions, and Spoken Language Ability. Differences in favor of Placebo were only observed on the Constructional Praxis subscale. This exploratory analysis suggests that tramiprosate may have some benefit on memory, language and praxis skills in mild to moderate AD individuals. Future clinical studies of tramiprosate should include specialized neuropsychological tests to validate its effects within these cognitive domains.

BackgroundGuidelines support the use of combination conventional synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs), switching csDMARDs and/or use of biologic DMARDs (bDMARDs) treatment in active rheumatoid arthritis (RA) after use of methotrexate (MTX).ObjectivesThe purpose of this study was to determine treatment practices after use of MTX in patients with RA who were on either monotherapy or combination csDMARDs in a large observational cohort (OBRI) in order to determine contemporary practice where use of bDMARDs from government coverage is restricted to active RA (+RF and/or +ACPA) or erosions, SJC≥5 with MTX failure, combination failure (triple csDMARDs: MTX + hydroxychloroquine + sulfasalazine) or use of leflunomide.MethodsPatients enrolled in OBRI with documented MTX failure defined as discontinuation due to side effect, primary/secondary failure, or patient/physician decision. Demographics and disease parameters at MTX failure were compared between monotherapy failures, double therapy (Rx) failures, and triple Rx failures.ResultsA total of 313 patients with MTX failure were included with a mean (SD) age of 58.8 (13.2) years and disease duration of 6.7 (8.2) years. Of these, 102 (32.6%) were on MTX monotherapy, 156 (49.8%) were double (MTX +1 csDMARD) Rx, and 55 (17.6%) were on triple or more (MTX + multiple csDMARDs)Rx, respectively, at the time of MTX failure. At the time of MTX failure disease duration was numerically higher in patients failing monotherapy and double Rx as compared to triple Rx (7.5 vs. 6.8 vs. 4.5 years, respectively; P=0.276) while patients failing triple Rx were more likely to have an erosion (43.1% vs. 37.2% vs. 61.8%; P=0.009) and had significantly higher patient global (3.5 vs. 3.9 vs. 4.8; P=0.046). When looking at patient transition to csDMARDs monotherapy, csDMARDs combination Rx or bDMARDs treatment, patients receiving monotherapy were more apt to have switches to other monotherapy (87% of patients), whereas those on combination Rx received more combination csDMARDs (78% and 74% of patients on MTX + 1 csDMARDs or MTX + multiple csDMARDs, respectively) and bDMARDs combination Rx (21% and 26%, respectively)(Figure 1).Figure 1.Treatment profile after MTX failure by type of MTX failureConclusionsThere are inherent differences in the selection of subsequent treatment regimen between patients failing MTX monotherapy vs. MTX combination therapy. Overall, the results of the current analysis suggest the use of a sequential treatment intensification strategy in routine clinical practice in Ontario.Disclosure of InterestNone declared

Background Assessment of the real-world effectiveness of newer biologics such as abatacept is essential in determining true benefits in routine practice. Patient registries represent a valuable supplement to randomized controlled trials including real world durability, and improvement of function over time. Objectives A large Canadian database was used to determine effectiveness of abatacept in real world RA patients including how many people need to be treated to improve 1 RA patient by a minimally important difference (MID) of the HAQ. Methods RA patients administered abatacept via clinic or home infusions from the Orencia Response Program network, between 2006 and Feb. 2011 with follow-up evaluation(s) were included. The number needed to treat (NNT) to improve HAQ by at least the MID (≥0.22) and abatacept survival until last follow up were calculated overall; and for abatacept as first or subsequent biologic. Results Among the 2,929 patients enrolled, 1,771 (60.5%) were eligible for the study (79.2% had past TNFi) with a mean (SD) follow up of 13.8 (12.3) months. Mean (SE) durability of treatment was 26.8 (0.53) months; where 66% were still on abatacept at 12 and 53% at 24 months. The survival was longer where abatacept was the first biologic vs. post TNFi (P=0.0001). In abatacept as 1stbiologic, 70% achieved MID in HAQ vs. 71% if post TNFi (P=0.65) with NNT=1.4 in each group and there were also no differences in % achieving MID comparing no past biologic to 2, 3 or 4 pervious biologics. Increased baseline HAQ (OR 2.13 (1.89, 2.39)) and less years of RA (OR 0.98 (0.97, 0.99)) were significant predictors of achieving the MID for HAQ. For those staying on abatacept, the mean improvement in HAQ increased over time; changing at 6, 12, 18 and 24 months by -0.29, -0.41, -0.45 and – 0.51 respectively with no difference between abatacept as first biologic vs. post TNFi (unadjusted) and if adjusting for baseline differences, change in HAQ was better as first biologic (p<0.001). ParameterPost DMARDPost TNFiTotal CohortP-Value N=369N=1,402N=1,771 Mean (SD) age (years)58.80 (13.65)57.28 (13.10)57.60 (13.23)0.0496 Mean (SD) time since diagnosis (years)13.25 (10.83)17.36 (10.92)16.53 (11.02)<0.001 Female gender: n (%)260 (70.46)1,107 (78.96)1,367 (77.19)<0.001 Disease severity: n (%)  Mild1 (0.27)4 (0.29)5 (0.28)0.736  Moderate22 (5.96)104 (7.42)126 (7.11)  Severe346 (93.77)1,291 (92.08)1,637 (92.43)  NA0 (0.00)3 (0.21)3 (0.17) Baseline HAQ1.45 (0.71)1.72 (0.69)1.66 (0.70)<0.001  12 Months–0.34 (0.66)–0.43 (0.67)–0.41 (0.67)0.207  24 Months–0.48 (0.70)–0.52 (0.70)–0.51 (0.70)0.786  36 Months–0.36 (0.69)–0.60 (0.71)–0.58 (0.71)0.297 Mean (SD) durability of treatment26.12 (0.86)25.75 (0.58)26.79 (0.53)<0.001 % on Abatacept (survival estimate)  12 Months746466  24 Months655053  36 Months564346 Conclusions Abatacept is effective in improving HAQ in RA despite long disease duration. For those still on abatacept, HAQ continued to improve over the first 2 years. The durability of abatacept is better as first biologic but NNT to improve HAQ is the same post DMARDs and TNFi. This can help to inform treatment decisions. Disclosure of Interest J. Pope Grant/Research support from: This study was supported by a grant from BMS. The protocol was developed by the authors for data analysis., E. Rampakakis: None Declared, J. Sampalis: None Declared, O. Desjardins: None Declared

Background COMPLETE-AS is an ongoing, multicenter, observational epidemiological study expected to enroll a total of 1,120 patients with ankylosing spondylitis (AS) from approximately 60 sites across Canada. The main objectives of this study is to compare the real – world effectiveness of adalimumab to NSAIDS and traditional non-biologic DMARDs in the management of extra-articular manifestations (EAMs) and to describe the burden of illness of AS and EAMs in terms of quality of life, health care utilization, work productivity, depression and psychological impairment in patients treated for two years. Objectives To describe demographics and baseline disease parameters of the cohort. Methods This pre-specified interim analysis includes patients enrolled between July 2011 and August 2013. Eligible participants must be ≥18 years old; have active AS per the judgment of the treating physician; require treatment change due to inadequate response or non-tolerance to current NSAID or DMARD treatment for AS. Patients are followed every 3 to 6 months following treatment change, according to the investigator's practice, for up to two years. Parameters captured include disease activity measures (BASDAI, BASFI), quality of life data (SF-36, BDI-II), and work limitations (WLQ). Results Of the 288 patients enrolled to date, 56.6% are male and 85.4% Caucasian. At baseline, mean (SD) age was 43.3 (13.6) years, and mean (SD) time from diagnosis was 5.5 (9.5) years; 64.8% were HLA-B27 positive, 22.9% were treated with a previous/concomitant DMARD [mean (SD) number 1.1 (0.3)], and all patients were biologic naïve. Mean (SD) baseline BASDAI and BASFI were 5.97 (2.06) and 5.06 (2.55), respectively. Baseline mean (SD) SF-36 PCS and MCS, and BDI-II were 27.6 (1.1) and 16.4 (1.1), and 13.6 (9.82). With respect to EAMs, history of IBD, uveitis and psoriasis was reported for 14.8%, 22.7% and 15.7% of patients with available data, respectively. Enthesitis at the Achilles tendon or plantar fascia was present in 17.3% of pts. Patients reported a mean loss of 16.9% in health-related work productivity while 9.7% of patients were unemployed due to disability. Patients enrolled in COMPLETE-AS are comparable to those observed in another Canadian cohort, Toronto AS registry1, with the exception of lower proportion of male and HLA-B27 positive patients, and a higher prevalence of psoriasis. Conclusions A noteworthy proportion of AS patients enrolled in this real-world observational study has EAM and work limitation. Further analysis will evaluate the impact of disease manifestations on health quality of life and work productivity. References Caplan L et al. Ankylosing Spondylitis Clinical Registries: Principles, Practices and Possibilities. Am J Med Sci 2013;345(6):437–439 Disclosure of Interest : L. Bessette Grant/research support: Abbvie, Consultant for: Abbvie, Speakers bureau: Abbvie, B. Haraoui Grant/research support: Abbvie, Consultant for: Abbvie, M. Khraishi Grant/research support: Abbvie, W. Bensen Grant/research support: Abbvie, Consultant for: Abbvie, Speakers bureau: Abbvie, J. John Sampalis Consultant for: Abbvie, M. Veronneau Shareholder of: abbvie, Employee of: Abbvie DOI 10.1136/annrheumdis-2014-eular.3835

BackgroundDespite the well documented effectiveness of anti-TNF treatment in rheumatoid arthritis (RA), some patients can be refractory to treatment (primary [1ry] failure) or may lose responsiveness (secondary [2ry] failure). In such cases, switching to another anti-TNF or a different biologic class can often restore therapeutic response.ObjectivesThe aim of this analysis was to assess the rate of non-response among RA patients treated with anti-TNFs in Canadian routine clinical practice.MethodsBioTRAC is an ongoing, prospective registry of patients initiating treatment for RA, ankylosing spondylitis, or psoriatic arthritis with infliximab (IFX) or golimumab (GLM). RA patients treated with IFX since 2002 or with GLM since 2010 who had at least one post-baseline assessment were eligible. Patients with available information on DAS28 or EULAR response in at least one post-baseline visit were included in the respective analyses.Results1,127 patients (75.6% female) were included with mean (SD) age of 56.1 (13.4) years and disease duration of 8.4 (8.9) years at baseline. The majority were biologic naïve (93.2%), treated with IFX (76.0%), and received a concomitant DMARD (86.2%) at baseline. Mean (SD) disease parameters at baseline were: CDAI: 33.9 (17.6); HAQ: 1.6 (0.7); SJC: 9.8 (6.8); TJC: 11.5 (8.0).After a mean (SD) follow-up of 35.5 (36.8) mos, 764 (67.8%) patients were discontinued overall and 226 (20.1%) due to effectiveness reasons (lack of response: n=67; loss of response: n=83; disease progression: n=76). Among the patients discontinued due to effectiveness reasons, the majority were discontinued after 12 months (54.4%) and had achieved prior good EULAR response (66.2%). Among patients discontinued due to lack of response, 17.7% and 45.5% had previously achieved DAS28 low disease activity (LDA) and good EULAR response, respectively; whereas, among patients discontinued due to loss of response, 46.9% and 76.8% had a previously documented achievement of the two targets, respectively.ConclusionsThe results of this analysis have shown a low rate of failure during treatment with IFX and GLM. Non achievement of DAS28 LDA was a good predictor of lack of response and more predictive than good EULAR response; non-achievement of good EULAR response, on the other hand, was a better predictor of loss of response. Overall, significant variation exists depending on each investigator's definition of 1ry and 2ry failure, which highlights the importance of establishing standardized definitions of these terms.Disclosure of InterestE. Keystone: None declared, P. Baer: None declared, W. Olszynski: None declared, M. Baker: None declared, B. Haraoui: None declared, W. Bensen: None declared, R. Faraawi: None declared, E. Rampakakis: None declared, J. Sampalis: None declared, A. Lehman Employee of: Janssen Inc., F. Nantel Employee of: Janssen Inc., B. Osborne Employee of: Janssen Inc., C. Tkaczyk Employee of: Janssen Inc., K. Maslova Employee of: Janssen Inc.