T. Schaeverbeke

Risk factors for severe infections in patients with rheumatoid arthritis treated with rituximab in the autoimmunity and rituximab registry

OBJECTIVEnThe risk of severe infection is a crucial factor in the assessment of the short-term risk:benefit ratio of biologic drugs in rheumatoid arthritis (RA). There is no increase in severe infections in RA patients treated with rituximab (RTX) in controlled trials, but this has not yet been assessed in daily practice. We undertook this study to investigate the occurrence of and risk factors for severe infections in off-trial patients using data from the AutoImmunity and Rituximab (AIR) registry.nnnMETHODSnThe AIR registry was set up by the French Society of Rheumatology. The charts of patients with severe infections were reviewed.nnnRESULTSnOf the enrolled patients, 1,303 had at least 1 followup visit at 3 months or later, with a mean ± SD followup period of 1.2 ± 0.8 years (1,629 patient-years). Eighty-two severe infections occurred in 78 patients (5.0 severe infections per 100 patient-years), half of them in the 3 months following the last RTX infusion. Multivariate analysis showed that chronic lung disease and/or cardiac insufficiency (odds ratio 3.0 [95% confidence interval 1.3-7.3], P = 0.01), extraarticular involvement (odds ratio 2.9 [95% confidence interval 1.3-6.7], P = 0.009), and low IgG level (<6 gm/liter) before initiation of RTX treatment (odds ratio 4.9 [95% confidence interval 1.6-15.2], P = 0.005) were significantly associated with increased risk of a severe infection.nnnCONCLUSIONnThe rate of severe infections in current practice is similar to that reported in clinical trials. The risk factors for severe infections include chronic lung and/or cardiac disease, extraarticular involvement, and low IgG before RTX treatment. This suggests that serum IgG should be checked and the risk:benefit ratio of RTX discussed for patients found to have low levels of IgG.

Positivity for anti-cyclic citrullinated peptide is associated with a better response to abatacept: data from the ‘Orencia and Rheumatoid Arthritis’ registry

Objectives Very limited data are available regarding the efficacy of abatacept (ABA) in real life. The aims of this study were to determine the efficacy of ABA in rheumatoid arthritis and predicting factors of efficacy in common practice. Methods The Orencia and Rheumatoid Arthritis” (ORA) prospective registry, promoted by the French Society of Rheumatology, has included 1003 patients with RA. Results 773 patients had already fulfilled the 6-month follow-up visit. Only 21.3% of patients would have fulfilled inclusion criteria used in pivotal controlled trials. The European League Against Rheumatism (EULAR) response, was observed in 330 (59.1%) of the 558 assessed patients (good response: 20.4%, moderate response: 38.7%) and was similar in patients who did and in patients who did not fulfill inclusion criteria of controlled trials. Among EULAR responders, initial 28-joint disease activity score (5.4 (4.7-6.5) in responders vs 4.9 (4.0-6.0) in non responders, p< 0.0001), the proportion of rheumatoid factor (75.6% vs 66.7%, p= 0.03) and the proportion of anti-cyclic citrullinated peptide antibody (anti-CCP)-positivity (75.9% vs 62.2%, p= 0.001) were significantly higher. In multivariate analysis adjusted on initial 28-joint disease activity score and CRP, anti-CCP positivity was associated with EULAR response (OR=1.9;95% CI=1.2 to 2.9, p=0.007), but not rheumatoid factor (OR=1.0;95% CI=0.6 to 1.6, p=0.9). Anti-CCP positivity was also significantly associated with a higher ABA retention rate at 6 months. Conclusions Real life efficacy of ABA in the ORA registry was similar as that reported in clinical trials. Anti-CCP positivity was associated with a better response to ABA, independently from disease activity.

Five-year favorable outcome of patients with early rheumatoid arthritis in the 2000s: data from the ESPOIR cohort.

Objective. To report the 5-year outcome of a large prospective cohort of patients with very early rheumatoid arthritis (RA), and to identify factors predictive of outcome. Methods. Patients were recruited if they had early arthritis of < 6 months’ duration, had a high probability of developing RA, and had never been prescribed disease-modifying antirheumatic drugs (DMARD) or steroids. Logistic regression analysis was used to determine factors that predict outcome. Results. We included 813 patients from December 2002 to April 2005. Age was 48.1 ± 12.6 years, delay before referral 103.1 ± 52.4 days, 28-joint Disease Activity Score (DAS28) 5.1 ± 1.3, Health Assessment Questionnaire (HAQ) 1.0 ± 0.7; 45.8% and 38.7% had rheumatoid factor or antibodies to cyclic citrullinated peptide (anti-CCP), respectively; 22% had hand or foot erosions; 78.5% fulfilled the American College of Rheumatology/European League Against Rheumatism criteria for RA at baseline and 93.8% during followup. At 5 years, 573 patients were evaluated. The outcome was mild for most patients: disease activity (median DAS28 = 2.5) and HAQ disability (median 0.3) were well controlled over time; 50.6% achieved DAS28 remission and 64.7% low disease activity. Radiographic progression was low (2.9 Sharp unit/year) and only a few patients required joint surgery. Nevertheless, some patients developed new comorbidities. During the 5 years, 82.7% of patients had received at least 1 DMARD (methotrexate, 65.9%), 18.3% a biological DMARD, and about 60% prednisone at least once. Anti-CCP was the best predictor of remaining in the cohort for 5 years, of prescription of synthetic or biologic DMARD, and of radiographic progression. Conclusion. The 5-year outcome of an early RA cohort in the 2000s was described. Anti-CCP was a robust predictor of outcome. The generally good 5-year outcome could be related to early referral and early effective treatment, key processes in the management of early RA in daily practice.

Predictive risk factors of serious infections in patients with rheumatoid arthritis treated with abatacept in common practice: results from the Orencia and Rheumatoid Arthritis (ORA) registry

Objectives Little data are available regarding the rate and predicting factors of serious infections in patients with rheumatoid arthritis (RA) treated with abatacept (ABA) in daily practice. We therefore addressed this issue using real-life data from the Orencia and Rheumatoid Arthritis (ORA) registry. Methods ORA is an independent 5-year prospective registry promoted by the French Society of Rheumatology that includes patients with RA treated with ABA. At baseline, 3 months, 6u2005months and every 6u2005months or at disease relapse, during 5u2005years, standardised information is prospectively collected by trained clinical nurses. A serious infection was defined as an infection occurring during treatment with ABA or during the 3u2005months following withdrawal of ABA without any initiation of a new biologic and requiring hospitalisation and/or intravenous antibiotics and/or resulting in death. Results Baseline characteristics and comorbidities: among the 976 patients included with a follow-up of at least 3u2005months (total follow-up of 1903 patient-years), 78 serious infections occurred in 69 patients (4.1/100 patient-years). Predicting factors of serious infections: on univariate analysis, an older age, history of previous serious or recurrent infections, diabetes and a lower number of previous anti-tumour necrosis factor were associated with a higher risk of serious infections. On multivariate analysis, only age (HR per 10-year increase 1.44, 95% CI 1.17 to 1.76, p=0.001) and history of previous serious or recurrent infections (HR 1.94, 95% CI 1.18 to 3.20, p=0.009) were significantly associated with a higher risk of serious infections. Conclusions In common practice, patients treated with ABA had more comorbidities than in clinical trials and serious infections were slightly more frequently observed. In the ORA registry, predictive risk factors of serious infections include age and history of serious infections.

OP0035 Tolerance of Rituximab, Abatacept and Tocilizumab in Common Practice: Analysis of the 3 Registries of the French Society of Rheumatology (Air, Ora and Regate)

Objectives To perform a joint analysis of the safety of abatacept (ABA), rituximab (RTX) and tocilizumab (TCZ) in real life. Methods The AIR, ORA and REGATE French Society of Rheumatology registries follow up prospectively patients with rheumatoid arthritis treated with RTX, ABA or TCZ. The analyses took into account serious infections that occurred in the 12 months that followed an infusion of rituximab in the absence of initiation of a new biologic or those who occurred under abatacept or tocilizumab or in the 3 months that followed their discontinuation, in the absence of initiation of a new biologic. Serious infections and cancers were validated by the review of the charts of patients. Results 1980 patients treated with RTX (current follow up of 6844 patient-years), 1024 patients with ABA (2882 patient-years), and 1503 patients with TCZ (1552 patient-years) (database of January 2013 for RTX and ABA and August 2013 for TCZ). – Serious infections: 309 serious infections occurred under RTX (4.5 serious infections/100 patient/years). 102 serious infections occurred under ABA (3.5 serious infections/100 patient/years). 55 serious infections occurred under TCZ (5.2 serious infections/100 patient/years). 3 tuberculosis infections (0.04/100 patient/years) occurred under RTX, 2 (0.07/100 patient/years) under ABA and no tuberculosis under TCZ. – Cancers: 85 cancers occurred under RTX (1.2/100 patient-years) including 14 non-melanoma skin cancers (0.2/100 patient/years), 71 solid cancers and haematological malignancies (1.0/100 patient/years) including 8 haematological malignancies (0.1/100/patient/years with 1 lymphoma).40 cancers occurred under ABA (1.4/100 patient/years) including 13 non-melanoma skin cancers (0.5/100 patient/years), 27 solid cancers and hematological malignancies (0.9/100 patients/year) including 4 haematological malignancies (0.14/100 patient/years, without lymphoma). 10 cancers were observed under TCZ (1.0/100 patient/years) including 2 non melanoma skin cancers (0.19/100/patient/years) 8 solid cancers and haematological malignancies 0.8/100 patient/years) including 3 haematological malignancies (0.29/100 patient/years) with 3 lymphomas. Conclusions Incidences of serious adverse events in real life patients with comorbidities were similar under ABA, RTX and TCZ to what is expected in rheumatoid arthritis treated with anti-TNF. With ABA, RTX and TCZ, the incidence of tuberculosis is low. Adjusted statistical comparisons of safety, efficacy and drug retention rate of these 3 biologics are currently performed. Disclosure of Interest None declared

THU0173 Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biologic Therapy in Patients with Rheumatoid Arthritis in Daily Practice: The Maintain Study

Background Efficacy and safety of TNFα inhibitors (TNFi) in rheumatoid arthritis (RA) have been evaluated in randomized controlled trials. The analysis of observational studies and registries provides additional real-world information. Drug survival rate reflects the real world balance between efficacy and safety. Objectives The primary objective of this study was to compare the retention rates (RR) of adalimumab (ADA), etanercept (ETN) and infliximab (IFX) as 1st-line biologic therapy in RA. The secondary objectives were to determine causes of discontinuation, factors associated with a better retention, and RR of 2d-line TNFi. Methods This is a retrolective, multicentre study in 8 French Rheumatology centres. The medical charts of all pts with RA who started TNFi therapy between March 1st 2005 and April 30th 2009 were reviewed, based on diagnosis and treatment (TT) codes, with a follow-up duration of min. 2 to max. 6 yrs. The RR was estimated using the Kaplan-Meier method. TNFi were compared after adjusting the inverse of a propensity score, using a Cox model. Factors associated with a better RR were identified by multivariate analysis. Results 706 pts were included in the study. The first TNFi was ADA in 203 (28.8%), ETN in 404 pts(57.2%) and IFX in 99 pts (14%). The percentage of pts still on TT after 2 yrs was 54.9%, 61.9% and 48.7% for ADA, ETN and IFX respectively. The median duration of trt was 31 mths for ADA (95% CI [19-38]), 45 mths for ETN (95% CI [35-51]) and 23 mths for IFX (95% CI [16-36]). The Hazard ratios (HRs) for discontinuing the first TNFi were significantly greater with ADA and IFX than with ETN (1.315, 95% CI [1.050-1.648] and 1.380, 95% CI [1.041-1.828] respectively). There was no significant difference between the 2 monoclonal antibodies. The HR for TT discontinuation due to lack of efficacy was significantly higher with ADA than ETN (1.511, 95% CI [1.152-1.982]). The HR for stopping trt due to adverse events was significantly higher with IFX than ETN (2.175 (95% CI [1.402-3.374]). Baseline characteristics associated with a better retention of the first TNFi were a higher number of previous DMARDs and a higher ESR. A second TNFi was administered to 231 pts: ADA in 105, ETN in 106, and IFX in 20 pts. The median retention period was 11 mths for ADA (95% CI [7-17]), 43 mths for ETN (95% CI [19.1-58]), and 19.1 mths for IFX (95% CI [5-NE]). The HR for discontinuing ADA was significantly greater than for ETN (2.023, 95% CI [1.393-2.937]). The HRs for stopping due to lack of efficacy or adverse events (AE) were significantly greater for ADA than for ETN (1.998, 95% CI [1.321-3.024] and 2.188, 95% CI [1.017-4.708] respectively). Conclusions ETN had a better RR as a first-line biotherapy in RA, with a HR for discontinuing ADA or IFX that was about 30% greater than that of ETN. As first-line biologic therapy, ETN had fewer withdrawals for inefficacy than ADA, and fewer withdrawals for AE than IFX. As a 2d-line TNFi, ETN also had a better RR than ADA. Disclosure of Interest A. Frazier-Mironer Consultant for: Pfizer, A. Cantagrel Grant/research support from: Chugai, Pfizer, UCB, Consultant for: Laboratoires BMS, Chugai, MSD France, Novartis, Pfizer, Roche, UCB, Speakers bureau: Laboratoires Abbott, BMS, Chugai, MSD France, Nordic-Pharma, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, B. Combe Grant/research support from: Pfizer, Roche, Chugai, Consultant for: BMS, Celgene, Merck, Novartis, Pfizer, Roche, Chugai, UCB, Speakers bureau: Merck, Pfizer, UCB, V. Deschamps Employee of: PFIZER, M. Dougados Grant/research support from: Pfizer, Abbott, Roche, BMS, Merck, Lilly, Novartis, Consultant for: Pfizer, Abbott, Roche, BMS, Merck, Lilly, Novartis, R.-M. Flipo Grant/research support from: Pfizer, Roche, Chugaï, Consultant for: Abbott, Astra-Zeneca, BMS, Ipsen-Ménarini, MSD, Pfizer, Roche, Chugaï, UCB, Janssen-Cilag, Paid instructor for: Abbott, Astra-Zeneca, BMS, Expansciences, Ipsen-Ménarini, MSD, Nordic-Pharma, Pfizer, Roche, Chugaï, Genzyme, UCB, I. Logeart Employee of: Pfizer, X. Mariette Consultant for: BMS, Pfizer, Roche et UCB, T. Schaeverbeke Consultant for: Roche, Chugai, Pfizer, J. Sibilia Grant/research support from: Roche, Pfizer, Merck Sharp, Bristol Myers Squibb, Speakers bureau: Roche, Chugai, Bristol Myers Squibb, Abbott, UCB, GSK, LFB, Actelion, Pfizer, Merck Sharp, Novartis, X. Le Loët Consultant for: MSD, Pfizer, Roche

SAT0386 Free DKK-1 Serum Levels Are Unchanged in Spondyloarthritis Patients Treated by Anti-TNF – Data from The Sparse Study

Background DKK-1 and SOST are two inhibitory proteins of the Wnt signaling pathway which lead to decreased bone formation by osteoblasts and osteocytes, respectively. Due to the limited data assessing free DKK-1 and SOST in SpA patients under anti-TNF treatment, a post-hoc examination of the SPARSE study was designed in order to answer these question. Objectives To assess free DKK-1 and SOST serum levels at Baseline and 24 weeks after etanercept or placebo treatment in patients from the SPARSE study. Methods In the SPARSE study, patients were randomized to receive either etanercept (N=42) or placebo (n=48) in case of active AxSpA disease (defined by mini BASDAI >40) despite optimal NSAIDs intake. The 90 patients from the SPARSE study were quantified for free DKK-1 and SOST serum levels, at Baseline and at Week 8 (w8) corresponding to the end of the placebo controlled period. DKK-1 and SOST serum levels were assessed by the use of a classic sandwich ELISA test (Biomedica, Vienna) and results were provided in pmol/L. Changes in DKK-1 and SOST serum levels were adjusted for disease activity, CRP levels, NSAIDs intake, X-ray status and treatment groups. Results LS Mean (±SE) serum DKK-1 at Baseline was not significantly different between treatment groups (ETN: 36.2 ± 1.97; PBO: 37.1 ± 1.84; p=0.72). At Baseline, DKK-1 was not associated with any of the patients or disease characteristics: ASDAS-CRP (r=0.096; 95% CI [-0.122, 0.305]); CRP (r=0.002; 95% CI [-0.210, 0.214]); X-ray status (LS Mean (SE): negative 37.4 (±2.38) versus positive 36.3 (± 1.77); p=0.71). There were no significant differences between treatment groups in the change from Baseline to w8 in the DKK-1 serum levels (p=0.97). We also considered patients with (N=67) or w/o NSAIDs intake (n=19) within the week preceding w8 serum level assessment and found no significant difference (p=0.99). We further assessed DKK-1 serum levels at Baseline according to their Baseline CRP (<6mg/L; ≥6mg/L), X-ray status (Positive; Negative), or NSAIDs intake (Yes; No) within the week preceding w8, and found no significant differences. These analyses were repeated for SOST serum levels at Baseline and with the exception of patients with Negative X-ray status at Baseline having significantly lower values than those patients with Positive X-ray status (p=0.047), no significant differences were observed in terms of the Baseline disease characteristics; Similarly there were no differences between treatment groups in the change from Baseline to w8 SOST serum levels. Conclusions This post-hoc examination of patients randomized in the SPARSE study suggest that etanercept does not significantly change DKK-1 or SOST serum levels within the 8 first weeks of treatment. Disease activity, CRP, NSAIDs intake and X-ray status were not significantly associated with DKK-1 serum levels. These results should be considered in the context of previous studies suggesting that DKK-1 was dysfunctional in SpA patients (1). Taken together, these results suggest that DKK-1 should not be considered as a valuable bone remodeling marker in SpA, unlike in rheumatoid arthritis. References Daoussis, D., et al. Arthritis Rheum, 62, 150–8 Disclosure of Interest C. Miceli-Richard: None declared, B. Combe: None declared, F. Berenbaum: None declared, T. Schaeverbeke: None declared, N. Koppiker Employee of: Pfizer, I. Logeart Employee of: Pfizer, A. Dubanchet Employee of: Pfizer, M. Dougados: None declared

AB0444 Impact of Gender on the Response and the Tolerance to Treatment with Abatacept in RA Patients: Results from the “Orencia and Rheumatoid Arthritis” Registry

Background Sex differences in rheumatoid arthritis (RA) outcomes as well as response rate to many RA therapies have been established. Response to DMARD or TNF blockers is lower in women. Conflicting data with Rituximab have been obtained from French and British registers and no data beyond 6 months of follow up have been published with Abatacept. Objectives Assess the impact of gender on the response and the tolerance with abatacept in RA patients. Methods 1017 patients were included in The Orencia and Rheumatoid Arthritis (ORA) prospective registry, promoted by the French Society of Rheumatology. Disease activity (DAS28) was assessed at baseline and during follow-up (6, 12 and 24 months). The relationship between the EULAR response, DAS28 remission, rate of adverse events (at 6, 12 and 24 months) and gender was explored in multivariate analysis using a random effects model considering interaction between gender and time, subject random effect, adjustment on age, disease duration,Rheumatoid factor (RF) or anti-CCP positivity, current DMARDS or previous TNF blockers, corticoids use, RA activity, and potential impact of missing data. Results 79.3% of the patients were female (age 57.3 years, disease duration 17 years [IQR 11-24]. RF and anti-CCP positivity was not different between females (69.8% and 68.5%) and males (76.9% and 75.5%). No difference was observed between sexes for the use of steroids (74.6%) or DMARDs (64.7%). At baseline, women had longer disease duration (p<0.001), higher disease activity (p=0.001), and had more often previously received anti-TNF drugs (p=0.04). The DAS28 remission rate was similar in the 2 sexes during the follow-up after adjustment on age, disease duration, RF or anti-CCP positivity, current DMARDS or previous TNF blockers, corticoids use, RA activity (Table 1). Patients with EULAR good-or-moderate response did not differ between men (52.4%) and females (55.5%). Moderate EULAR response was more frequent in women at 6 months but was no longer significant at 12 or 24 months. Time to achieving EULAR good-or-moderate response was similar in women and men (5.4±4.9 vs 5,6±5.2 months, p=0.67). Treatment with abatacept was maintained similarly in 86.9, 72.5, 52.8% of men and 91.1, 72.8, 55.8% of women at the 6, 12, 24 month follow-up visits respectively.73.1% of women and 69.4% of men stopped at least one time the treatment during the follow-up (p=0.3) because of inefficacy in 72% and 64.4% respectively (p=0.09), of adverse events in 14% and 15% (p=0.76). Conclusions In this large cohort of RA patients treated with Abatacept in real life, after 2 years of follow-up, similar rate of remission and good-or-moderate EULAR response were observed between men and women after adjustment on disease activity. Drug retention rate and safety were also comparable. Disclosure of Interest None declared

THU0264 In Early Rheumatoid Arthritis (Espoir Cohort), Serum CCL19 Level is Associated with Disease Activity, Autoantibody Secretion and 3-Year Radiographic Progression: Data from the Espoir Cohort

Background The interferon (IFN) signature has mainly been studied in established rheumatoid arthritis (RA), and was associated with poor response to rituximab. Serum levels of CCL2 (Monocyte Chemotactic Protein 1, MCP-1), CXCL10 (Interferon gamma –inducible 10 kDa Protein, IP-10) and CCL19 (Macrophage Inflammatory Protein 3 beta, MIP-3beta) are associated with an interferon (IFN) gene signature and disease activity in systemic lupus. Objectives The objectives of the study were to assess the association between the IFN serum signature, disease activity, autoantibody secretion, radiographic progression and rapid initiation of a biologic DMARD in early RA. Methods Serum levels of CCL2, CXCL10, and CCL19 were assessed in the ESPOIR cohort composed of 813 patients with early arthritis (more than 6 weeks and less than 6 months) not treated with steroid or DMARD. RA was defined according to ACR/EULAR 2010 criteria. An elevated level of each chemokine was defined as a value greater than the mean + 2DS value of the control population (88 sex and age-matched subjects). Patients with at least 2 out of 3 IFN-regulated chemokines were defined to have an IFN-high score. Results Among the 813 patients included in the ESPOIR cohort, 641 patients had RA according to ACR/EULAR 2010 criteria. Elevated levels of CCL2, CXCL10, CCL19 were observed in 1.9% of early RA patients vs 0.6% of patients with other early arthritides (P=0.5), 49.4 vs 38.2% (P=0.01) and 23.3 vs 7.1% (P<0.0001), respectively. An IFN-high score was observed in 15.1% of RA patients vs 2.9% of patients with other early arthritides (P<0.0001). Among the 641 patients with RA according to ACR/EULAR 2010 criteria, CXCL10 and CCL19 were significantly correlated with DAS28 at enrollment (r=0.22 and r=0.16, respectively,P<0.0001 for both) whereas CCL2 was not. Patients with RF or anti-CCP autoantibodies only had elevated levels of CCL19 (315.5[142.6-631.6] vs 214.4 [101.2-443.0] pg/ml, P<0.0001 and 332.6 [161.1-645.8] vs 214.5 [96.4-447.6] pg/ml, P<0.0001) whereas they had similar CCL2 and CXCL10 levels. RF and anti-CCP positivity were not associated with IFN-high score. Radiographic progression at 3 years (increase of total Sharp score greater than 5) was only associated with increased levels of CCL19 (P=0.05) but not with CCL2 or CXCL10, or with IFN-high score. Initiation of a biologic DMARD within the first year after enrollment was only significantly associated with increased levels of CCL19 (391.8 [197.3-548.6] vs 263.1[166.4-533.8] pg/ml, P=0.03). Conclusions In early RA, serum CCL19 level is associated with disease activity, autoantibody secretion and 3-year radiographic progression. Patients with a high-IFN serum signature represent 15% of patients with early RA, with a rather good prognosis since high-IFN serum signature was not associated with autoantibody secretion, radiographic progression, or rapid initiation of a biologic DMARD treatment of RA. Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.4239

SAT0044 Five-Year Favourable Outcome of Patients with Early Rheumatoid Arthritis in the 2000S: Data from the Espoir Cohort

Objectives To report the 5-year outcome of a large prospective cohort of patients with very early rheumatoid arthritis (RA), and to identify predictive factors of outcome. Methods Patients were recruited if they had early arthritis of less than 6 months’ duration, a high probability of developing RA, and had never been prescribed DMARDs or steroids. Patients were followed every 6 months during the first 2 years, then every year. Logistic regression analysis was used to determine predictive factors of outcome. Results 813 patients were included from December 2012 to april 2005: age was 48.1 ± 12.6 years, delay before referral 103.1 ± 52.4 days, DAS28 5.1 ± 1.3, HAQ 1.0 ± 0.7; 44.2 and 38.8% had IgM Rheumatoid Factor or anti-CCP2 antibodies; 22% had hands or feet erosions; 78.5% fulfilled the ACR/EULAR criteria for RA at baseline and 93.8% during follow-up. 573 patients were evaluated at 5 years. The outcome was mild for most patients: disease activity (median DAS28 2.5) and HAQ (median 0.3) were well controlled over time; 47.6% achieved DAS28 remission and 64.6% low disease activity in the first 2 years. Radiographic progression was low (2.9 Sharp unit / year). Only a few patients required joint surgery, but some developed new co-morbidities (eg, hyperlipemia, cardiovascular diseases). During the 5 years, 82.7% of patients had received at least one DMARD (methotrexate: 65.9%) usually as monotherapy, 18.3% a biological DMARD, and about 60% prednisone at least once (mean dosage 8.8 ± 7.7 mg/day). Anti-CCP2 antibodies was the best predictor of 5-year remaining in the cohort, prescription of synthetic or biologic DMARDs, and radiographic progression. Conclusions The generally good 5-year outcome of this cohort could be related to early referral, early effective treatment and close monitoring which are key processes in the management of early RA in daily practice. Disclosure of Interest B. Combe: None Declared, N. Rincheval: None Declared, J. Benessiano: None Declared, F. Berenbaum: None Declared, A. Cantagrel: None Declared, J.-P. Daures: None Declared, M. Dougados: None Declared, P. Fardellone: None Declared, B. Fautrel: None Declared, R.-M. Flipo: None Declared, P. Goupille: None Declared, F. Guillemin: None Declared, X. Le Loet: None Declared, I. Logeart Employee of: Pfizer, X. Mariette: None Declared, O. Meyer: None Declared, P. Ravaud: None Declared, A. Saraux: None Declared, T. Schaeverbeke: None Declared, J. Sibilia: None Declared