Session Type: Abstract Submissions (ACR)
Baseline factors influencing the use of tocilizumab (TCZ) in monotherapy (Mono) instead of combination with DMARDs (Combo) in real-life practice in RA patients (pts) as described previously in the Act Solo study were: no MTX treatment over the past 2 years, past-history of severe infection, age ≥ 65 years and an increased DAS28-ESR1.
Objective: To describe drug retention rate, efficacy and tolerance of TCZ in real life in RA patients at 6 months
Study design: prospective, multicenter, longitudinal, non interventional 12-month study. Patients: RA requiring TCZ treatment according to their physician. Treatment: TCZ as prescribed in real life. Primary endpoint1: Baseline factors influencing the use of TCZ in Mono or in Combo. Secondary endpoints: drug retention rate, premature withdrawals, safety and efficacy. Data collected: pts’ characteristics at baseline and after TCZ initiation, monthly disease activity components, RA treatments. Statistical analysis: pts fulfilling inclusion and non-inclusion criteria and with ≥1 TCZ infusion were analyzed.
We herein present only the results at 6 months.
608 patients were recruited of whom 603 were analysed for safety and 577 (Total) for other endpoints. Baseline characteristics: mean age 57±13 years, 454 (79%) females, at least 1 co-morbidity: 409 (71%), mean RA duration 11±9 years, RF or ACPA positive: 479 (86%), erosive disease: 435 (77 %), mean DAS28-ESR 5.2±1.3. Past RA treatments included DMARDs in 98% and biologics in 75%. MTX was previously prescribed in 94% of pts and in 69% within the last 2 years. TCZ Mono was initiated in 229 (40%) pts and TCZ Combo in 348 (60%) pts of whom 74% received MTX (mean dose 16±5mg). Steroids were used in 385 (67%) pts (mean dose 10±7mg). 386 pts completed M6. 86 pts had no M6 visit. 105 pts withdrew for: AE 38 pts, inefficacy 28, patient’s wish 6, lost to follow-up 15, remission 1, wish of pregnancy 1, unknown 14. 2 pts died: stroke 1, inhalation pneumopathy 1. At M6, drug retention rate was 78% in Total, 75% in Mono, 79% in Combo. Among the 577 pts, 211 (37%) pts remained without DMARD, 366 (63%) received TCZ+DMARD. DMARD was added in 18 TCZ Mono pts (twice on a temporary way) and definitely stopped in 23 TCZ Combo pts. 199 (34%) pts experienced at least 1 dose modification (temporary or definitive stop, dose changing) in TCZ infusions, 90 (39%) pts in TCZ Mono and 109 (31%) in TCZ Combo group. During the period 362 (63%) pts received steroids; at M6, 235 (41%) pts remained on steroids. Mean DAS28-ESR in Total, Mono and Combo were 2.80±1.49, 2.89±1.50 and 2.74±1.49 respectively. DAS28-ESR remission was 31% in Total, 28% in Mono, 33% in Combo. DAS 28-ESR LDA was 40% in Total, 38% in Mono, 42% in Combo. No new safety signal was reported. 264 (44%) patients had at least one AE, 46 (8%) had at least one serious AE.
In this 6-month interim analysis, drug retention rate was 78% in pts receiving TCZ in real life. In Total mean DAS 28-ESR decreased from 5.2±1.3 to 2.80±1.5 No new safety signal occurred. Both TCZ Mono and TCZ Combo groups were comparable for drug retention, efficacy and safety.
This study was conducted thanks to an unrestricted grant from Roche Chugai France.
Ref.: 1. Maillefert et al. ACT SOLO EULAR 2014 SCIE-1154
R. M. Flipo,
J. F. Maillefert,
« Back to 2014 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/which-factors-influence-the-prescription-of-tocilizumab-alone-or-in-combination-with-dmardsa-in-rheumatoid-arthritis-patients-in-a-real-life-setting-an-interim-analysis-of-safety-and-efficacy-a/