Objectives The effectiveness of TNF inhibitors in RA has been shown to be affected by obesity. No such effect has been found for abatacept and rituximab, while for tocilizumab results are ambiguous. Additionally, it remains unresolved whether sex is an effect modifier for obesity. We investigated the impact of obesity on the drug effectiveness of conventional synthetic or biologic DMARDs, taking into account potential sex-specific differences. Methods Data from 10 593 RA patients included in the German observational cohort study Rheumatoid Arthritis: oBservation of BIologic Therapy (RABBIT) since 2009 were analysed. Patients had to have a BMI ≥18.5 kg/m2, at least one follow-up and 6 months of observation time. The influence of obesity on drug effectiveness was investigated by regression analysis, adjusting for potential confounders. Results Obesity had a negative impact on improvement in the DAS with 28 joints using ESR as an inflammation marker of –0.15 (95% CI: –0.26; –0.04) units for women receiving conventional synthetic DMARDs, –0.22 (95% CI: –0.31; –0.12) units for women receiving TNF inhibitors, –0.22 (95% CI: –0.42; –0.03) units for women receiving tocilizumab and –0.41 (95% CI: –0.74; –0.07) units for men receiving tocilizumab. Overall, no negative obesity effects on the effectiveness of rituximab and abatacept were found. Conclusion Obesity has a negative impact on the effectiveness of cytokine-targeted but not cell-targeted therapies in daily practice, affecting more outcomes and therapies in women than in men. Overall, no effects of obesity on treatment effectiveness were found for rituximab and abatacept.

Aim: To analyze the quality of life (QoL), work productivity and activity impairment (WPAI) and healthcare resource utilization (HCRU) in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients receiving golimumab under routine clinical settings in Germany. Materials & methods: Prospective observational study, GO-ART, analyzed changes in WPAI, QoL and HCRU during 24 months of golimumab therapy. Results: Seven hundred and forty-eight patients (RA = 250, PsA = 249 and AS = 249) were enrolled. Substantial improvements in WPAI scores presenteeism, activity impairment and total work productivity impairment and QoL were observed at month three and were maintained through month 24. Fewer patients had disease-related hospitalizations and consulted physician at month 24 than at the baseline. Conclusion: Golimumab induces sustained improvements in WPAI and QoL and reduces healthcare resource utilization in RA, PsA and AS.

BackgroundWhile effectiveness of TNF inhibitors (TNFi) and, to some extent, tocilizumab (TOC), has been shown to be affected by obesity in patients with rheumatoid arthritis (RA), no such effect has been found for abatacept (ABA) and rituximab (RTX). Also, it remains unresolved whether gender is an effect modifier for obesity, e.g. due to different body fat distributions in men and women.ObjectivesAssess whether obesity affects drug effectiveness of common DMARDs, taking into account potential differences between sexes. As measures for effectiveness, the degree of improvement regarding DAS28-CRP as well as its components after 6 months of treatment were considered.MethodsData of 8,623 RA patients included since 2009 in the German observational cohort study RABBIT were analysed. Patients had to have a BMI ≥18.5 and at least 6 months of follow-up. Multiple imputation of missing values in outcomes was performed. The influence of obesity (BMI ≥30) on drug effectiveness was investigated by multiple linear regression, adjusting for age, baseline value of the outcome of interest, disease duration, prior bDMARD failure, glucocorticoid therapy, number of comorbidities, joint erosions, autoantibody status, and smoking habits.ResultsAt baseline, obese patients were comparable to others in age (both mean 58 years) and gender (women: 75% vs. 74%). They were less likely to be seropositive (66% vs. 75%), had less erosions (40% vs. 52%) but more often ≥3 comorbidities (43% vs. 30%). With the exception of infliximab, around 90% of patients or more received the recommended drug dosage regardless of their weight (assuming a tolerance interval for norm in case of weight-dependent infliximab and tocilizumab dosages). For women treated with TNFi or csDMARDs as well as for patients treated with TOC, obesity had a negative influence on the improvement in DAS28-CRP after 6 months of treatment (figure 1). With the exception of patients treated with TOC, this influence seemed to be caused mostly by inflammation, while for joint swelling or pain no associations were observed. Men and women treated with TNFi differed significantly regarding the effect of obesity on the improvement of log(CRP) values.Abstract SAT0702 – Figure 1Influence of obesity on the RA disease course regarding the improvement in DAS28-CRP and its components after 6 months of treatment, as assessed by multiple linear regression. Shown are point estimates and 95% confidence intervals for obesity effects, separately for men (left, dashed line) and women (right, solid line) in five treatment groups.ConclusionsThe influence of obesity on drug effectiveness depends on the considered outcome and, to some extent, on gender. It may therefore be worthwhile to assess it separately for men and women.AcknowledgementsThis abstract is part of the METARTHROS cooperation funded by the German Federal Ministry of Education and Research (01EC1407D).Disclosure of InterestM. Schäfer: None declared, Y. Meissner Speakers bureau: Pfizer, J. Kekow: None declared, S. Berger: None declared, S. Remst...

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Background The ICHIBAN study collects clinical routine data to evaluate the efficacy and safety of tocilizumab (TCZ) in pat. with rheumatoid arthritis (RA) over a period of 2 years. Methods The start of this prospective, non-interventional study, being intended to include 4000 pat., was in Feb. 2010. Clinical data of RA pat., their therapies, therapeutic responses, pat. related outcomes and adverse events are collected “on the fly” using an online database with structured web forms. Results On 18th December 2011 as reference date, baseline data of 1036 pat. were available. In 343 pat. observation period was already at least 52 weeks or discontinuation or change of a treatment was documented. 75.4% of the 1036 pat. were female, the mean age was 56.0 years. Pat. suffered from RA since 10.1 years in mean and the baseline DAS28 was 5.4. 73.3% of the pat. had concomitant diseases. 74.4% were pretreated with TNF-alpha inhibitors, 23.9% exclusively with synthetic DMARDs. In week 52 (LOCF) 31.1% of the pat. (N=97/312) showed a remission of DAS28 (<2,6). A moderate or good EULAR response was seen in 32.3% or 42.2% of the pat., respectively. The mean number of tender joints decreased from 10.1 to 4.4, the mean number of swollen joints from 7.3 to 2.5. The mean ESR decreased from 35.4 to 13.7 mm/1h and the CRP from 3.3 to 0.8 mg/dl. Data on pat. reported outcomes (PRO) and functional status at week 52 are shown in Tab. 1. In 21.9% of the pat. (N=75/343) treatment was changed during the observational period of 52 weeks. The total TCZ exposition was 910.1 pat. years. 781 adverse events were reported (in 339 of the 1036 pat.; 85.8/100 pat. years). 147 of these events were infections (16.2/100 pat. years). 160 serious adverse events were reported (in 95 pat.; 17.6/100 pat. years), 110 of which included an at least improbable causal relationship with TCZ (12.1/100 pat. years). Table 1. Means of VAS scales (mm), FFbH and HAQ Week 0 (Baseline)Week 52 (LOCF)N Disease activity (100 = strongest possible activity)65.240.4249 Health state (100 = very bad)63.041.0248 Exhaustion/fatigue (100 = very strong)60.543.8246 Pain intensity (100 = intolerable pain)65.141.5247 Sleep disturbances (100 = very strong)49.739.8245 FFbH (%)58.664.4249 HAQ1.41.2221 Conclusions The results of this “real life study” represent a severely diseased RA population showing significant impairments. The first 343 patients having completed the first observation period of at least one year show clear improvements in all recorded RA parameters. These data confirm the results of previous real life studies with TCZ such as ROUTINE and TAMARA. The safety results correspond to the expectations. Disclosure of Interest C. Specker Grant/Research support from: Has received honoraria from Chugai for advising in study design and conduction and fees for talks, in summary less than €10.000/year, J. Kaufmann: None Declared, M. Vollmer: None Declared, H. Kellner: None Declared, M. Bohl-Bühler: None Declared, M. Aringer: None Declared, A. Alberding: None Declared, H. Schwenke:...