Background/Purpose: 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 over the past 2 years, past-history of severe infection, age ≥ 65 years and an increased DAS28¹.  Drug retention rate, efficacy and tolerance of TCZ at M12 with a focus on Mono and Combo are described here. 

Methods: Prospective, multicenter, longitudinal, non-interventional 12-month study in RA pts requiring TCZ according to their physician. Treatment: TCZ as prescribed in real life. Primary endpoint¹: Baseline factors influencing the use of TCZ in Mono or 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: Efficacy population was pts fulfilling inclusion and non-inclusion criteria and with ≥1 TCZ infusion. Safety population was all pts with ≥1 TCZ infusion. 

Results: 608 pts were recruited of whom 603 were analysed for safety and 577 (Total) for other endpoints. At baseline: 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: 478 (86%), erosive disease: 435 (77 %), mean DAS28: 5.2±1.3. Past RA treatments included DMARDs + biologics in 75%, only DMARDs in 24%. MTX was previously prescribed in 95% of pts and in 71% within the last 2 years. TCZ Mono was initiated in 228 (40%) pts and TCZ Combo in 349 (60%) pts of whom 80% received MTX (mean 16±5mg/w). Steroids (GCs) were used in 386 (67%) pts (mean 10±7mg/d). 337 pts completed M12 visit. 194 pts withdrew for: AE 53 pts, inefficacy 88, patiens wish 12, lost to follow-up 23, other 18. At M12, drug retention rate was 69% in Total, 67% in Mono, 71% in Combo. Mean number of TCZ infusions was 9.4±4.1; mean time between infusions was 31.8 ±12.6 days. 29% of the pts experienced at least 1 discontinuation, 25% and 33% in Mono and Combo groups respectively. DMARD was added in 20 Mono and definitely stopped in 25 Combo pts. 170 (50%) pts remained on GCs, 66 (51%) in Mono group and 104 (50%) in Combo group. At M12, mean DAS28 in Total, Mono and Combo were 2.4±1.3, 2.4±1.3 and 2.3±1.2 respectively. DAS28 remission was 35% in Total, 35% and 36% in Mono and Combo respectively (p=0.83). Using propensity score, no effect of Mono was observed on drug retention HR= 1.194 [0.852,1.673], p=0.30 ; DAS remission OR= 1.111 [0.773,1.597], p=0.57; or GCs use OR= 0.880 [0.558,1.387], p=0.58 at M12. No new safety signal was reported. 325 (54%) patients had at least one AE, 74 (12%) had at least one serious AE with no differences between Mono and Combo. 

Conclusion: At 12 months, drug retention rate was 69% in pts receiving TCZ in real life. In Total group mean DAS28 decreased from 5.2±1.3 to 2.35±1.26. No new safety signal occurred. Propensity scores showed no differences between Mono and Combo for drug retention, DAS remission or use of steroids. Safety was comparable in both groups.

 This study was conducted thanks to an unrestricted grant from Roche Chugai France.

 Ref.: 1. Maillefert et al. ACT SOLO EULAR 2014 SCIE-1154

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