Background Biologic disease-modifying antirheumatic drugs (bDMARDs) are increasingly used for treating patients with different rheumatic diseases. The safety and effectiveness of using biologics therefore become important issues of the rheumatologists' practice.
Objectives To analyze the data, gathered over the 6 year-experience of using bDMARDs in Moscow Regional Research and Clinical Institute (“MONIKI”), including safety issues, reasons for biologic switch and its frequency.
Methods A retrospective open cohort study was conducted. 159 patients (female – 89; 56%; men – 70; 44%), that were followed up at the rheumatology department of “MONIKI” for more than 0,5 year during the period from the 01 Sept 2009 until the 01 Nov 2015, and taking bDMARDs, were randomly included, regardless of the diagnosis or the biologic agent. To the undesirable events during the treatment with bDMARDs applied: cases of infections (latent or active tuberculosis, active herpes zoster infection, candidiasis, urinary infection, unusually frequent acute respiratory infections, pneumonia) and elevated liver enzymes.
Results The median age of patients was 46 years. The median duration of the disease – 12 years. The diagnoses were ankylosing spondylitis (n=83; 52,2%), rheumatoid arthritis (n=58; 36,48%), psoriatic arthritis (n=15; 9,4%), systemic lupus erythematosus (n=2; 1,3%), Takayasu arteritis (n=1; 0,6%). The used bDMARDS were infliximab (n=63; 39,62%), adalimumab (n=42; 26,42%), etanercept (n=18; 11,32%), rituximab (n=16; 10,1%), abatacept (n=7; 4,4%), golimumab (n=6; 3,77%), tocilizumab (n=3; 1,89%), belimumab (n=2; 1,26%), certolizumab pegol (n=2; 1,26%). In 45 patients (28,3%) the biologic was switched, in 13 – two or more times. In 17 patients (37,8% of all switches) the underlying cause was an ineffectiveness of the bDMARD; in 14 (31,1%) the reason for the switch were adverse events or infusion reactions. Most frequently were switched for the reason of ineffectiveness etanercept (14,8%) and infliximab (14%). The incidence of the undesirable events among all the agents was 8,344 per 100 patient years. 8,18 per 100 patient years in rituximab; 5,34 in etanercept; 10,11 in infliximab and 6,14 in adalimumab patients. One adverse event was registered on abatacept patient. The median period of adverse events appearance was 12 months. Infusion reactions were most common in patients taking rituximab (n=7; 43,8%; p<0,01) and none were present in patients on etanercept. Ten cases of tuberculosis were registered during the treatment with infliximab, including 1 lethal case, therefore one or none cases were registered in patients taking other bDMARDs.
Conclusions In our department, ankylosing spondylitis was the most frequent reason for treatment with biologics. For the reason of ineffectiveness almost one third of patients have required a biologic switch and a large part even more than once. Another one third of switches was made due to undesirable events or infusion reactions. Infliximab is widely used for the treatment of patients with rheumatic diseases, although we registered an increased frequency of undesirable events during the treatment with infliximab, including tuberculosis, and a high frequency of the switch for the reason of ineffectiveness.
Disclosure of Interest None declared