Background Rheumatoid arthritis (RA) is an autoimmune disease with involvement of small and large joints. Biologic agents (BA) represent treatment options if disease is not controlled by DMARDs. Many questions regarding the safety of BA (especially the infections) remain unanswered.
Objectives To estimate the effectiveness of BA, the adverse reactions (AR) and their severity compared to DMARDs. To search whether we can achieve better results and fewer AR when BA are administered according to EULAR guidelines, than delayed.
Methods This is a retrospective study of 1.118 patients files (875 women and 243 men, mean age at disease initiation 48.2 and 47.4 years respectively). Demographic and clinical data were recorded. There were 691 incident (61.8%) and 427 prevalent cases (38.2%), while 340 patients (30.4%) received one or more BA. Disease activity was classified with DAS-28 score. All AR were categorized according to the international system CTCAE (grades 1-2 for mild/moderate reactions with local or noninvasive intervention, 3 for severe reactions that need hospitalization, 4 for life-threatening reactions and 5 for death). Effectiveness and AR of BA were analyzed, taken in to account their administration according to EULAR guidelines or not.
Results Mean duration of follow-up for all patients was 47.5 months; for those received BA was 80.6 months (mean duration of BA administration 52.1 months) and for DMARDs 40.6 months. DAS-28 score before treatment was 4.97 for all patients (for BA 5.3 before and 2.84 after treatment). For patients with DMARDs, 295/1.118 achieved remission (26.4%) and 185/1.118 low disease activity (16.5%), while of those on BA, 159/340 achieved remission (46.8%) and 84/340 low activity (24.7%). Effectiveness of BA was significantly higher compared to that of DMARDs (p<0.0001 for remission and p<0.0001 for both remission and low disease activity). Similar results were noticed when incident and prevalent cases were analyzed separately. In contrary, 57 infections were recorded in patients treated with DMARDs and 137 among those with BA (p<0.0001). AR (grade 3-5) were recorded more commonly during BA treatment than during DMARDs (67 vs. 29 respectively, p<0.0001). Patients received BA according to guidelines (n=116) were compared with 224 patients who received BA with delay. Remission and low disease activity taken together was achieved in 93/116 (80.2%) and 145/224 (64.7%) patients respectively (p=0.0028). Proper administration of BA was accompanied by fewer infections (17 against 121 respectively, p<0.0001), especially for serious ones (2 against 26, p=0.0025). Except infections, 25 AR were recorded in 1st and 113 in 2nd group (p=0.0006) whereas serious AR (grade 3-5) were 6 in the 1st and 30 in the 2nd group (p=0.0389).
Conclusions BA are highly effective compared to DMARDs, for the treatment of RA and when administered, according to EULAR guidelines, they cause fewer AR as compared to their delayed use. On the contrary, these agents are accompanied by more serious AR, which have to be taken in to account when making therapeutic decisions.
Disclosure of Interest None Declared
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