Etanercept for rheumatic diseases: gastrointestinal ADRs

Abstract

Although patients with inflammatory rheumatic diseases treated with etanercept may experience gastrointestinal adverse drugs reactions (GI-ADRs), the incidence is comparable to treatment with adalimumab, according to study results reported in the Journal of Rheumatology. Dutch Biologic Monitor data was used to investigate patient-reported GI-ADRs experienced with biologics between January 2017 and March 2020. From the 416 evaluated patients, 25 patients reported 36 GI-ADRs. The most frequently reported events were diarrhoea, nausea, and abdominal pain. Ten of the events developed within the first month of treatment, and 11 events reportedly occurred after each etanercept administration, with recovery within a few days. Using the Naranjo Probability Scale, 2 events were classified as probable and 34 were classified as possible. On a scale of 1 (no burden) to 5 (very high burden), the mean burden score was 2.6. Dutch Rheumatoid Arthritis Monitoring (DREAM-RA) and Dutch Registry for Spondyloarthritis (SpA-Net) data were used to investigate healthcare professional-registered GI-ADRs. From the 399 etanercept recipients, 9 patients developed 11 GI-ADRs, an incidence of 7.14 per 1000 patient-years. Five events developed within 5 months of starting treatment. Using the Naranjo Probability Scale, 2 events were classified as probable and 9 were classified as possible. In the Dutch Biologic Monitor data, the GI-ADR frequency for etanercept (8.7%) was similar to that for adalimumab (5.3%). Similarly, in the DREAM-RA/SpA-Net data, the GI-ADR frequency for etanercept (2.8%) was similar to that for adalimumab (4.7%). This is remarkable , note the authors, since GI-ADRs had previously not been described in adults using ETN [etanercept], except for several cases of IBD . Knowledge about these previously unknown ADRs can facilitate early recognition and improve patient communication , note the authors, who add that systematically questioned patient-reported ADR experiences should be included more often in assessing the ADR profile of treatment options in inflammatory rheumatic disease .