Abstract
Background: While the risk of tuberculosis (TB) reactivation is well known in relation to TNF-alpha-inhibitors (TNFi), the same risk for other non-TNFi/ Biologicals is not well addressed.
Methods: We conducted a systematic review of randomized phase 2 and phase 3 studies, long-term extensions of same, published through March 2019. We extracted all information about screening and treatment of latent TB infection (LTBI) in the context of 12 selected Biologics. We searched MEDLINE and the ClinicalTrial.gov database for all studies meeting these criteria.
Results: 127 studies out of 677 citations comprising a total of 34,293 patients who received Biologics were eligible for evaluation. Only 80 out of 127 studies (63%) captured active TB (or at least opportunistic diseases) as potential outcomes and 25 TB cases were reported. More than two thirds of publications (68%) mentioned LTBI screening prior to inclusion of study participants in the respective trial, whereas in only 4 studies LTBI screening was explicitly considered redundant. In 21 studies, patients with LTBI were generally excluded from the trials and in 33%, patients with LTBI received preventive therapy (PT) at least 3 weeks prior to a treatment with a biologic.
Conclusions: The lack of information in many non-TNFi studies on the number of patients with LTBI who were either excluded or received a PT hampers the assessment of the actual risk of TB reactivation for patients treated with biologics. Therefore, in case of insufficient information about drugs, we recommend applying the same safety measurement as in patients with TNFi. Also, well designed, real world register studies on TB progression risk may help to achieve valid conclusions in the future.
Footnotes
Cite this article as: European Respiratory Journal 2021; 58: Suppl. 65, PA1039.
This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2021