Background EULAR guidelines1 recommend to use biologics in combination with a DMARD, usually methotrexate (MTX). However, biologics in monotherapy (Mono) represent about 30% of the biologic-treated rheumatoid arthritis (RA) patients (pts) in registries2.
Objectives To describe factors influencing the use of TCZ in Mono or in combination with DMARDs (Combo) in real-life practice in RA pts.
Methods Study design: French prospective, multicenter, observational study. Patients: RA pts requiring TCZ treatment according to their physician. Treatment: TCZ IV as prescribed in real life. Primary Endpoint: Evaluation of factors influencing the use of TCZ in Mono or in Combo. Data collected: Demographic characteristics, past medical history, RA characteristics and history including previous RA treatments, TCZ treatment strategy (Mono or Combo), quality of life. Statistical analysis: Eligible pts having received ≥1 TCZ infusion were analyzed. 1- Descriptive analysis 2- Uni- and multivariate analysis to determine factors influencing the use of TCZ in Mono.
We herein present only the results of the primary endpoint and pts characteristics.
Results 124 physicians recruited 608 patients, of whom 575 were analysed. Pts characteristics at baseline: mean age 57±13 years, 78% female, mean RA duration 11±9 years, 86% rheumatoid factor and/or ACPA positive, 77% with erosive disease on X-rays, mean swollen joint count (JC) 6±5.1 and tender JC 9.1±6.8, ESR 30±24mm, mean DAS28-ESR 5.2±1.3 and mean HAQ 1.6±0.6. Pts medical history included hypertension (24%), dyslipidemia (18%), lung (16%), liver (9%), renal (4%) and cardiovascular diseases (4%), severe infection (8%), cancer (4%). Past RA treatment included DMARDs in 98% and biologics in 76%. MTX was previously prescribed in 94% of pts and prescribed within the last 2 years in 69%. TCZ alone was initiated in 39.5% of pts and in Combo in 60.5% among whom 77% with MTX (mean dose 16±5mg). Corticosteroids were used in 67% of pts (mean dose 10±7mg). Main reasons for not prescribing DMARDs were adverse effects to DMARDs (76%), DMARDs inefficacy (31%), patient's wishes (11%), non superiority of TCZ Combo vs Mono (5%), better safety profile of TCZ Mono (4%). In the univariate analysis, variables associated with TCZ prescription in Mono were age ≥65 years, past-history of lung/gastro-intestinal disease, severe infection and dyslipidemia, no MTX treatment over the past 2 years, increased DAS28-ESR/number of swollen joints/ESR/CRP. In the multivariate analysis, variables associated with TCZ prescription in Mono were no MTX treatment over the past 2 years (OR 5.31, 95%CI [3.66-7.71], p<0.0001), past-history of severe infection (OR 2.16, 95%CI [1.12-4.15], p=0.021), age ≥65 years (OR 1.58, 95%CI [1.08-2.31], p=0.018) and higher DAS28-ESR (OR 1.21 for each DAS unit, 95%CI [1.04-1.39], p=0.011).
Conclusions Physicians' prescription of TCZ in monotherapy was associated with the absence of MTX treatment in the past 2 years, elderly pts (age ≥65 years), a past history of severe infection and a more active disease. The latter needs to be further explored in terms of potential confounding factors and medical interpretation.
Smolen J, et al. ARD 2013;0:1–18
Soliman M, et al. ARD 2011;70:583–589
Acknowledgements This study was conducted thanks to an unrestricted grant from Roche Chugai France.
Disclosure of Interest J.-F. Maillefert Consultant for: Roche Chugai, J. Antheaume Employee of: Roche, D. Pau Employee of: Roche, R.-M. Flipo Consultant for: Roche Chugai, J. Tebib Consultant for: Roche Chugai