Objectives To assess if reduced dose of iTNF is not less effective than complete dose for response maintaining
Methods Prospective, randomized, multicenter, real life open-label study of non-inferiority coordinated by Spanish Societies of Clinical Pharmacology and Rheumatology.
Patients included were randomized (1:1) in a complete dose arm (C) or in a reduced dose arm according to a previous standardized protocol (E).
The primary objective was the proportion of patients who after a year of following maintained the acceptable therapeutical goal (ATG) (BASDAI, physicianVAS, patientVAS, night axial pain all <4). Secondary endpoints were: proportion of patients with clinical remission) (BASDAI, physicianVAS, patientVAS, night axial pain all <2), disease activity assessed with ASAS, BASFI and quality of life.
The main analysis was made per protocol (PP), considering an ATG percentage in C group of 87% with a maximum settled difference between both treatments inferior than 17%
Results 113 AS, 84% men, age of 45'6y and mean disease duration of 13'5y. 22 (40%) were treated with adalimumab, 19 (35%) with etanercept, 10 (27%) with infliximab and 4 (7%) with golimumab. Main results are shown in table1. At 12 months follow-up 48 (82.8%) in the full dose arm vs 47 (85.5%) in reduced dose arm maintained the ATG demonstrating the non inferiority hypothesis (p=ns, dif -2.5%, 95%CI -16.6 to 11.7%). We did not observe also any significant difference in any of the rest of variables analyzed including the proportion of patients in remission and safety issues. Although 30% of patients showed ≥1 flare, without differences between both treatment arms, less than 15% required treatment dropout.
Conclusions In patients with persistent clinical remission, dose reduction is not inferior to the standard dose. The presence of clinical flare is not uncommon, although less than half of cases lead to a change in the treatment.
Disclosure of Interest None declared