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...

Background:Non-interventional studies (NIS) are essential instruments in pharmaceutical research not only for pharmaceutical companies but also for regulatory authorities or reimbursement bodies in Germany.Aside from direct costs caused by a disease, German sick funds as well as health authorities have a keen interest in indirect costs, such as costs derived from loss of work productivity.Objectives:It is the aim of this study to show the benefit of Golimumab (GLM) in work productivity and activity for RA, AS and PsA patients in Germany. The analysis was performed using the validated indication-specific Work Productivity Activity Impairment (WPAI) Questionnaire as primary endpoint. The WPAI is rated to be the most psychometrically validated and frequently used instrument for measuring of health-related work-productivity.Methods:As primary endpoint, the change of work productivity impairment and ability for daily activities in month 3 (V1) versus baseline visit (V0) was evaluated.All 4 subscores of the WPAI were analysed: disease related absence from work (absenteeism), working while sick (presenteeism), total work productivity impairment (TWPI) and activity impairment with TWPI as primary score.In addition, an evaluation of the activity impairment in the mITT population (modified-Intention-To-Treat) was performed.As exploratory endpoint, the change in work productivity/activity impairment after 6 months and 12 months versus baseline as measured by WPAI for PsA, RA and AS patients treated with Golimumab in German clinical practice was evaluated.Results:Of 748 patients (100%) who started treatment with Golimumab at V0 (baseline), 666 (89.0%), 634 (84.8%) and 552 patients (73.8%) continued treatment until V1 (Month 3), V2 (Month 6), and V3 (Month 12/end of observation period), respectively.Efficacy analyses were performed on the mITT population which included 700 patients (RA=237, PsA=235, AS=228) who had at least 2 documented visits.The statistically significant improvements (all p-values <0.05) in the mean WPAI domain scores were maintained over the 12-month observation period in all 3 indications with a higher treatment effect regarding “activity impairment” and “presenteeism” than with “absenteeism”. The magnitude of improvements in the 4 WPAI domains and the time course of improvements varied between the underlying disease (RA, PsA, AS).In general, the improvements in the 4 WPAI domains were greater in patients with AS and PsA compared to RA patients. A continuous improvement over time was seen in AS patients regarding the domain “activity impairment. A positive effect of pre-treatment with biologics (i.e. better improvement in WPAI) was seen in RA patients for 3 domains (TWPI”, absenteeism, presenteeism), and in PsA patients for 2 domains (absenteeism, activity impairment).Conclusions:Golimumab s. c. 1 x monthly is an effective treatment in patients with RA, AS and PsA.All scores of the WPAI showed a significant (p<0.05) reduction in mean score values in each indication.Golimumab leads to an improvement of work...

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:...

BackgroundGolimumab (GLM) has shown its efficacy and tolerability in various randomized clinical trials. Systemic data for GLM regarding health-economic parameters in daily clinical practice are essential not only for pharmaceutical companies but also for cost-benefit analyses in Germany.ObjectivesThis prospective NIS was designed to evaluate the impact of GLM therapy on work productivity and activity as well as Quality of Life (QoL) in patients with RA, AS or PsA in Germany under routine settings over an observation period of 12 months, plus an additional voluntary extension period of 12 months (total 24 months) to collect long-term data on health economic parameters.MethodsGO-ART was an observational prospective study on patients with RA, AS or PsA (biologic-naïve and biologic-experienced) who started treatment with GLM at 63 sites of Germany.The primary endpoint was the change in work productivity/activity impairment as measured by Work Productivity and Activity Impairment (WPAI) questionnaire from baseline, measured primarily at month 3 and secondarily at months 6, 12 and 24.As secondary endpoint the change in quality of life (RAQoL for RA patients, ASQoL for AS patients and NAPPA-QoL for PsA patients) was assessed.Results748 patients (RA=250, PsA=249, AS=249) started GLM therapy.The primary efficacy endpoint was analyzed in the modified intention-to-treat (mITT) subset of 493 patients (RA=158, PsA=157, AS=178) with full-time or part-time employment at baseline (mITTe).A total of 348 patients entered the additional 12-month observation period, of which 303 completed the 24-month assessment.By 3 months after initiation of Golimumab treatment, a marked improvement was seen in all 4 WPAI domain scores (“absenteeism” (time off work), “presenteeism” (on-the-job productivity), “total work productivity impairment” (TWPI), and “activity impairment”) in daily living because of patient’s health problems related to RA, PsA or AS, as shown in Table 1 (all p-values <0.05).The statistically significant improvements in the mean WPAI domain scores were maintained over the 24-month observation period in all 3 indications with a higher treatment effect regarding “activity impairment” and “presenteeism” compared to “absenteeism” (Table 1).Quality of life improved significantly (p<0.0001) from baseline at month 3, 6, 12 and 24 in patients with RA (RAQoL), AS (ASQoL) and PsA (NAPPA-QoL) based on questionnaire data of 237 RA patients (RA-mITT), 228 AS patients (AS-mITT) and 235 PsA patients (PsA-mITT) indicating a clinically relevant improvement.ConclusionTreatment with GLM provided sustained improvement in WPAI and QoL in patients with RA, PsA and AS over the observational period of 24 months.All scores of the WPAI showed a significant (p< 0.05) reduction in mean score values in each indication.GLM leads to an improvement of work productivity and daily activities in patients already within the first 3 months of treatment.Disclosure of InterestsInes Klaudius Employee of: MSD Sharp & Dohme GmbH, Klaus Krueger: None declared, Sven Re...

Background The treatment of RA with biologic (b)DMARDs should usually be combined with the non-biologic (nb)DMARD methotrexate (MTX). Randomized controlled trials showed superior efficacy of combination therapy in RA patients. Nevertheless, in daily clinical care about one third of patients have to be treated with monotherapy due to intolerability of MTX or other nbDMARDs. The effectiveness of this treatment regime has rarely been studied in unselected RA patients. Objectives To investigate characteristics of patients treated with bDMARDs in monotherapy versus those with bDMARDs in combination with MTX and to compare treatment adherence and comedication. Methods Patients enrolled in RABBIT with abatacept (ABA), adalimumab (ADA), etanercept (ETA) and tocilizumab (TOC) from 2007 to 2012 who had at least one follow-up (N=1937) were stratified according to their treatment with bDMARD monotherapy or bDMARD + MTX. Therapy discontinuation within the first 12 months of follow-up was examined with Kaplan-Meier methods. Results Irrespective of the particular bDMARD, patients on monotherapy were significantly older, less frequently males, had more comorbidities, poorer physical function and were more often treated with high doses of concomitant prednisone (>10mg/day; p<0.01). Chronic renal and liver diseases were 2 to 5 times more frequent in patients on monotherapy (p<0.01; Table). There was no difference regarding treatment adherence between monotherapy and combination of bDMARDs with MTX for all agents except ADA. However, patients on monotherapy more frequently remained on higher doses of glucocorticoids after 6 months (table). For ADA, treatment continuation was significantly higher in combination with MTX (70.5/12 months [CI 65.3-75.0]) than on monotherapy (53.8 [CI 46.6-60.4]). Table 1. Characteristics of patients Conclusions A considerable proportion of severely affected patients with RA cannot be treated with MTX due to comorbid conditions. This applies in particular to older and multimorbid patients who could benefit from a similarly tolerated and effective monotherapy with the bDMARDs ABA, ETA or TOC. However, it has to be kept in mind that higher dosages of glucocorticoids were needed to reach the comparable effectiveness. For ADA, combination with MTX is advisable. Disclosure of Interest A. Richter Grant/research support: The German Biologics Register RABBIT is supported by a joint unconditional grant from AbbVie, Bristol-Myers Squibb, MSD Sharp & Dohme, Pfizer, Roche and UCB., J. Listing: None declared, J. Kekow: None declared, S. Balzer: None declared, S. Remstedt: None declared, A. Zink: None declared, A. Strangfeld: None declared DOI 10.1136/annrheumdis-2014-eular.3691

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