Tocilizumab and rituximab have similar effectiveness and are both superior to a second tumour necrosis factor inhibitor (TNFi) in rheumatoid arthritis patients who discontinued a first TNFi

摘要

abstract_textpObjectives: To compare the effectiveness of a 2nd TNF inhibitor (TNFi), Tocilizumab (TCZ) and Rituximab (RTX), measured by drug retention and by response rates, in rheumatoid arthritis (RA) patients after discontinuing a first-line TNFi and to clarify the reasons and predictors for discontinuation of a second-line biologic./ppMaterial and Methods: Non-interventional prospective study of RA patients exposed to a 2nd TNFi, TCZ or RTX after previous TNFi discontinuation using real-world data from Reuma.pt database. Drug retention was estimated using Kaplan-Meier analysis and Cox models. Crude and LUNDEX adjusted response rates were evaluated at 6 months, 1 and 2 years, and reasons for discontinuation were compared according to biologic class./ppResults: In total, 643 patients were included, 88.8 females, with a mean age of 59.4 +/- 12.8 years. Of those, 390 (60.7) initiating a 2nd TNFi, 147 (22.9) received TCZ and 106 (16.5) RTX. Drug retention was significantly greater among patients who initiated TCZ (76.4 +/- 4.3 months) or RTX (80.8 +/- 4.8 months), compared with those who initiated a 2nd TNFi (52.7 +/- 2.6 months) (log rank test, p0.001). In the adjusted Cox model, hazards (HR) of discontinuation were significantly lower for TCZ (HR 0.39, 95 CI 0.23-0.64, p0.001) and RTX (HR 0.42, 95 CI 0.25-0.72, p=0.001). Smokers had a significantly higher risk for discontinuation (HR 2.43, 95 CI 1.50-3.95,p0.001) as well as patients with higher Health Assessment Questionnaire (HAQ) at baseline (HR 1.51, 95 CI 1.14-2.00, p=0.004). The proportion of patients in remission or low disease activity according to Clinical Disease Activity Index (CDAI) at 6 months, 1 and 2 years was, respectively, 46.5/50.0/61.2 for TNFi, 52.9/53.6/69.2 for TCZ and 37.7/48.0//50.0 for RTX. After LUNDEX adjustment, response rates were, respectively, 33.0/31.0/31.8 for 2nd TNFi, 42.8/41.8/53.3 for TCZ and 32.0/39.4//39.0 for RTX. The main reasons for discontinuation were inefficacy for 2nd TNFi and RTX and adverse events for TCZ (p0.001)./ppConclusions: Our findings showed a significantly higher drug retention for TCZ and RTX, compared with 2nd TNFi, and similar persistence among TCZ and RTX, in patients who discontinued a first-line TNFi. These data corroborate the notion that switching to a biologic with a different mode of action is more effective than to a second TNFi./p/abstract_text