D. Wendling

Predictors of response and remission in a large cohort of rheumatoid arthritis patients treated with tocilizumab in clinical practice

OBJECTIVEnThe objective of this study was to identify predictors of response and remission to tocilizumab (TCZ) in RA patients seen in daily routine clinical practice.nnnMETHODSnThe efficacy of TCZ was evaluated after 12 and 24 weeks of treatment by the European League Against Rheumatism (EULAR) response criteria. Regression analysis was performed to study the association between remission or EULAR response and the following characteristics: gender, age, current smokers, prior cardiovascular disease (CVD), 28-joint disease activity score (DAS28), CRP, RF or ACPA positivity, combination therapy with DMARDs and TCZ as the first biological therapy or after failure of at least one biological therapy.nnnRESULTSnIn total, 204 patients were included with a mean DAS28 score of 5.14. EULAR response and remission were obtained in 86.1% and 40% of patients, respectively, at week 24. In multiple regression analysis, a high baseline CRP level [odds ratio (OR) 4.454 (95% CI 1.446, 13.726)] was significantly associated with EULAR response at week 24 and, inversely, age >55 years [OR 0.285 (95% CI 0.086, 0.950)] and prior CVD [OR 0.305 (95% CI 0.113, 0.825)] were significantly associated with lower EULAR response at week 24. Older age was also associated with less remission at week 24 [OR 0.948 (95% CI 0.920, 0.978)]. No additional effectiveness was found when TCZ was used in combination with a DMARD or when patients were naive to biological agents.nnnCONCLUSIONnIn daily practice we identified three predictors of a better response for TCZ therapy in RA: a younger age, a high baseline CRP level and no history of CVD.

Rituximab therapy for systemic vasculitis associated with rheumatoid arthritis: Results from the Autoimmunity and Rituximab Registry

Rituximab improves articular symptoms in rheumatoid arthritis (RA) and it recently has been shown to be an effective induction therapy for antineutrophil cytoplasmic antibody–associated vasculitis. We assessed the efficacy and safety of rituximab in a real‐life clinical setting among patients with systemic rheumatoid vasculitis (SRV).

Safety of surgery after rituximab therapy in 133 patients with rheumatoid arthritis: data from the autoimmunity and rituximab registry.

We used data from the AutoImmunity and Rituximab (AIR) registry to investigate the safety of surgery for patients with rheumatoid arthritis receiving rituximab (RTX) in routine care.

THU0375 ASDAS-Based Remission Was Less Frequent than BASDAI-Based Remission, and Both Were Related To CRP and Smoking in Early Axial Spondyloarthritis. The Desir Cohort: Table 1

Background Remission is the final goal for treat to target strategy in axial spondyloarthritis (axSpA). No clear definition is currently recognized, but ASDAS-CRP inactive state or BASDAI threshold (1) have been proposed. The frequency of remission using these definitions and factors associated with remission are unknown in early axSpA. Objectives To evaluate the percentage of patients in remission in early AxSpA, comparing different definitions of remission, and to evaluate factors associated with remission at inclusion in the DESIR cohort and after 24 months. Methods DESIR is a prospective observational cohort of patients with recent onset (less than 3 years) inflammatory back pain, beginning before 45 years, suggestive of axial SpA. For each of three definitions of remission (ASAS partial remission (PR), ASDAS-CRP less than 1.3 (ASDAS-R), BASDAI less than 3.6 (1) (BASDAI-R)), the ability to detect patients in remission according to the two other definitions was assessed using ROC curves and Areas Under the Curve (AUC). Data at baseline (M0) and M24 were analyzed, to look for factors (clinical, biological and imaging) associated with remission in uni and multivariate analysis by logistic regression. Results 706 patients were evaluated at M0 and 577 at M24. At M0, the percentage of patients in remission was 4% (PR), 8% (ASDAS) 34% (BASDAI), and at M24: 15%, 24% and 54% respectively, in the whole population and in Amor, ESSG and ASAS classified patients, but lower in mNY patients (data not shown). BASDAI less than 3.6 detected best patients in PR and ASDAS-R, with AUC of 0.84 and 0.86 respectively. In univariate analysis at M0, lower ESR and CRP, DKK-1, low BMI, male gender, absence of psoriasis, less smoking, HLA-B27 positivity, ASAS criteria fulfillment, positive sacro iliac imaging, less analgesics use and less subsequent use of anti TNF at M24 were associated with remission (ASDAS-R, BASDAI-R). No association was found with age, disease duration, enthesitis, uveitis, IBD, NSAID use, mSASSS. In multivariate analysis, remission was associated with lower ESR, less smoking, use of analgesics. At M24, low ESR and CRP, female gender, less smoking, less NSAID use, lower NSAID score, ASAS criteria fulfillment, lower biologics use and lower systemic steroid use were associated with remission in univariate analysis. In multivariate analysis, remission was associated with less smoking, less analgesics, ASAS clinical arm fulfillment, less NSAIDs (ASDAS-R), low CRP (ASDAS-R), low BMI (BASDAI-R) (Table 1).Table 1 Remission ASDAS-R r, p BASDAI-R r, p ASDAS <1.3 BASDAI <3.6 M0 (N=706) CRP −0.59*** ESR −0.04* Smoking −1.5** Smoking −0.93* Analgesics 1.55*** Analgesics 1.39** M24 (N=577) CRP −0.6*** BMI −0.14** Smoking −1.08* Smoking −1.16** ASDAS clinical 1.76* ASAS clinical 1.28* NSAIDs −1.4** Analgesics −2.02*** Analgesics −1.74*** Conclusions In this population suggestive of early SpA, acute phase reactants and analgesics were associated with remission at baseline and M24, but smoking appears as a major marker of disease activity and remission in early AxSpA. References Godfrin-Valnet M, Puyraveau M, Wendling D. J Rheumatol. 2014;41(3):617–8. Acknowledgement The DESIR cohort is supported by an unrestricted grant from PFIZER France. Disclosure of Interest None declared

OP0303 Systematic screening of comorbidities improves vaccination rates, skin cancer screening and vitamin d supplementation in patients with axial spondyloarthritis: results of the comedspa prospective, controlled, one year randomised trial

Background Specific recommendations for the detection/prevention of comorbidities have been proposed for patients with SpA. However, we know that often a gap exists between recommendation and their implementation in daily practice Objectives To evaluate the impact of a program of systematic screening of comorbidities and its management (detection/prevention). Methods Prospective, randomised controlled open, 12u2009month trial (NCT02374749). Patients: Axial SpA (according to rheumatologist). Study treatment: Collection of data by the nurse during a specific out-patient visit for the 5 studied SpA comorbidities (i.e. cardiovascular disease (CVD), osteoporosis, cancer, infection and peptic ulcer) according to the recommendations of the French Society of Rheumatology. In the event of non-agreement with the recommendation the patient was informed. A report summarising the results of this program prepared by the nurse was sent to the patient’s attending physician and rheumatologist. Treatment allocation: After written informed consent, the study treatment was allocated randomly. Outcome variables: the main outcome was the change after one year of a comorbidity score. This weighted composite comorbidity score ranged from 0 to 100, where 0=optimalu2009management of the 5 studied comorbidities and its weights were derived from the percentage of attributed mortality in SpA to each comorbidity in the literature, i.e. 40 points for CV disease, 20 points for cancer and infection, 10 points for osteoporosis and 10 points for peptic ulcer. The number of patients with actions undertaken against comorbidities according to the recommendations during the 12 months following this program were defined as secondary variables Results There were no differences in the baseline characteristics of the 502 recruited patients (252 and 250 in the active and control groups, respectively): Age: 46.7±12.2 years, male gender: 62.7%, disease duration: 13.7±11.0u2009y, Xray sacroiliitis 62.8%, MRI sacroiliitis 65.7%, current biologic treatment: 78.3%, ASDAS-CRP: 1.9±0.8, BASFI: 25.6±22.3. During the 1u2009year follow-up period, the comorbidity score decreased more in the active group, but this difference was not significant (−3,20 vs −1.85). The number of actions per patient was statistically higher in the group comorbidities : 4.54±2.08u2009vs 2.65±1.57 (p<0.001); the number of patients with actions performed to be in agreement with recommendations during the 12u2009months follow-up was higher in the active group for infections (flu vaccination : 28.6% vs 9.9%, p<0.01; pneumococcal vaccination:40.0% vs 21.1%,p=0.04), skin cancer screening (36.3% vs 17.2%; p=0.04), and osteoporosis (BMD performed: 22.6% vs 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs 9.4%, p<0.01). Conclusions This study highly suggests the short-term benefit of program on the systematic screening of comorbidities for its management in agreement with recommendations, even if this young age population of axSpA patients. Acknowledgements This study was conducted thanks to a grant from the French National Research Program (PHRC) thanks to an unrestricted grant from ABBVIE. Disclosure of Interest None declared

THU0418 Variable Selection is not Useful in the Construction of a Propensity Score for the Evaluation of TNF-Alpha Blockers' Treatment Effect of in Early Spondyloarthritis: Data from the DESIR Cohort

Background The use of propensity scores (PS) to balance covariates in the groups of treatment in order to address the indication bias in treatment effect evaluation in longitudinal studies, are more and more frequently used. However, no consensus exists regarding the selection of covariates to include in the PS. Objectives To compare two approaches for variable selection in the construction of a PS for TNF alpha blockers (TNFb) effectiveness assessment in a cohort of patients (pts) with inflammatory back pain (IBP). Methods Prospective, multi-centre cohort (DESIR). 708 pts with early IBP suggestive of ax-SpA. Data of the first 2 years of follow-up were included in this analysis. Statistical analysis: a) Exposure: receiving at least 1 TNFb during the first 2 years of follow-up. b) Outcome: ASAS40 response at the last available visit still on treatment (mean 74±30.9w). Data to assess such outcome was available in 197 pts c) Construction of 2 PS:PScomplete: logistic regression was calculated to predict exposure by including all covariates available at baseline visit (except for comorbidities) in the model. No variable selection (no univariate testing or correlation testing) was performed. PSselect: association of each covariate to the outcome was tested by univariate analysis, and only variables with a significant (p<0,10) association were selected. Among these, correlations were tested; in case of two variables were highly correlatied the most clinically informative was selected to be included in the model. e) Outcome comparison: the 197 pts on TNFb were matched (1:1 nearest neighbour technique) to controls according to both PS; the outcome was estimated by logistic regression. Results PScomplete included 52 variables. PSselect included only 9 variables. Variables selected in PSselect with a significant association with outcome were: gender (p=0,0024), synovitis (p=0.0297), uveitis (p=0.0138), highest education level (p=0.0859), BASGweek (p=0.0174), disease activity (physician) (p=0.0034), HLA-B27 (p=0.0087), ESR (p <0.0001), CRP (p=0.0002), Xray sacroiliitis (p=0.0072) and MRI sacroiliitis (p=0.0001); among these, some were highly correlated and were eliminated. The final PSselect model included 9 covariates: gender, synovitis, disease activity, highest level of education, uveitis, MRI sacroiliitis, X-ray sacroiliitis, CRP and HLAB27. Model comparison: Likelihood test p<0,0001 (PScomplete fitted the data significantly better); AUC=0,8759 (PScomplete) vs. 0.7614 (Psselect); Response to anti-TNF was similar using both PS techniques: ASAS 40 OR =2.75 [1.66–4.54] (p=0,004) in favour of the TNFb treatment with PScomplete, and OR =2.29 [1.26–4.142] for PSselect (p=0.006). Conclusions Variable selection for construction of PS did not show any advantage compared to include all available covariates: the selective model failed to better fit data and the outcome estimation was comparable with either model. Furthermore in both cases, TNFb lead to a doubled chance of ASAS 40 response at 2 years. The effectiveness of TNFb may be sufficiently robust to “erase” methodological differences. Simulation studies should allow confirming our findings. Acknowledgements Anna Molto has been granted with a bursary from Société Français de Rhumatologie Disclosure of Interest : None declared DOI 10.1136/annrheumdis-2014-eular.2570