Background Although glucocorticoid treatment may be appropriate in RA patients, there is general agreement that glucocorticoid therapy sparing is desirable when possible (1, 2). The safety of corticosteroids is duration and dosage dependent and the risk is peculiarly demonstrated for a dosage greater than 5 mg per day. TCZ is an effective biologic therapy in RA, even without concomitant methotrexate.
Objectives The aim of this study is to describe the steroid sparing effect in patients treated with TCZ in real life clinical setting.
Methods Patients: Patients included in the study presenting definite and active RA were treated by more than 5 mg daily of prednisone equivalent for at least 3 months and initiate TCZ treatment. Study design: Multicenter, prospective, non-interventional study 12 month-follow-up. Data collected: Demographic data and disease history at baseline, and after TCZ initiation monthly disease activity components and glucocorticoid dosage. HAQ-DI and RAID were completed every 6 months. Analysis: Patients fulfilling inclusion and non-inclusion criteria and with at least one TCZ infusion were analyzed. Last Observation Carried Forward (LOCF) method (quantitative analysis) or non-responder imputation (qualitative analysis) were used to handle missing cortisone dose value. We report here the results of the first 6 months of follow-up.
Results 106 physicians recruited 322 patients. 308 of them were analyzed (mean age 57±14 years, 240 female (78%), disease duration 10±9 years, RF or anti-CCP positive: 250 (82%); DAS 28-VS: 5.1±1.3; CDAI: 27±12; SDAI: 29±13; HAQ: 1.6±0.7; RAID: 6.2±2.0; 216 (70%) previously treated by biologic DMARD). TCZ was initiated as monotherapy in 117 (38%) patients. At TCZ initiation, 92 (30%) patients received more than 10 mg of prednisone daily, 137 (44%) 7.5 to 10 mg, 79 (26%) 5 to 7.5 mg with a mean dose of 12±7 mg per day. After 6 months of follow up, 59 % had good EULAR response and 25% moderate response (16% no response). At this time, only 14% received prednisone daily dose > 10 mg, 21% 7.5 to 10 mg, 25% 5 to 7.5 mg and 40% received less than 5 mg (Figure 1). At 6 months, 105 (34%, 95%CI [29%; 39%]) patients received ≤ 5 mg of prednisone without DMARD intensification and 9% have stopped corticosteroids. No new safety signal was reported with TCZ treatment in this study.
Conclusions This study is the first large prospective study demonstrating that TCZ allows a decrease of corticosteroid dosage in RA. Around a third of patients were able to decrease their prednisone dose to 5 mg or below at 6 months.
Dernis E et al - Joint Bone Spine 2010 Oct;77(5):451-7
Mouterde G et al - Joint Bone Spine. 2010 Dec;77(6):597-603
Disclosure of Interest A. Saraux Consultant for: Roche-Chugai, MSD, BMS, Abbvie, UCB companies, S. Rouanet Employee of: Roche, R.-M. Flipo Consultant for: Roche-Chugai, MSD, BMS, Abbvie, UCB companies, J.-C. Poncet Grant/research support from: Roche-Chugai company, P. Fardellone Grant/research support from: Roche-Chugai company, C. Contré Employee of: Chugai Pharma, A. Cantagrel Consultant for: Roche-Chugai, MSD, BMS, Abbvie, UCB companies