FRI0324 Which Factors Influence the Prescription of TOCILIZUMAB (TCZ) Alone or in Combination with DMARDS in Rheumatoid Arthritis Patients in A REAL Life Setting? the Act Solo Study
Authors: J.-F. Maillefert, J. Antheaume, D. Pau, R.-M. Flipo, J. Tebib
Journal: Annals of the Rheumatic Diseases (2014)

<h3>Background</h3> EULAR guidelines<sup>1</sup> 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 registries<sup>2</sup>. <h3>Objectives</h3> To describe factors influencing the use of TCZ in Mono or in combination with DMARDs (Combo) in real-life practice in RA pts. <h3>Methods</h3> <i>Study design</i>: French prospective, multicenter, observational study. <i>Patients</i>: RA pts requiring TCZ treatment according to their physician. <i>Treatment:</i> TCZ IV as prescribed in real life. <i>Primary Endpoint</i>: Evaluation of factors influencing the use of TCZ in Mono or in Combo. <i>Data collected</i>: Demographic characteristics, past medical history, RA characteristics and history including previous RA treatments, TCZ treatment strategy (Mono or Combo), quality of life. <i>Statistical analysis</i>: 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. <h3>Results</h3> 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%), patient9s 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&lt;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). <h3>Conclusions</h3> Physicians9 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. <h3>References</h3> Smolen J, et al. ARD 2013;0:1–18 Soliman M, et al. ARD 2011;70:583–589 <h3>Acknowledgements</h3> This study was conducted thanks to an unrestricted grant from Roche Chugai France. <h3>Disclosure of Interest</h3> 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 <h3>DOI</h3> 10.1136/annrheumdis-2014-eular.1154