A meta-analysis showed an increased risk for herpes zoster infection among patients with inflammatory bowel disease (IBD) and other immune-mediated inflammatory diseases (IMIDs) taking Janus kinase (JAK) inhibitors.
The researchers noted as the number of treatment options for IBD grows, decisions on how to position them will become more challenging.
“With an increasing therapeutic armamentarium, treatment algorithms in IBD will become more complex, with several drug classes and many compounds within each class will become difficult to determine adequate drug positioning,” wrote the researchers in Gastroenterology. “Knowing the exact safety profile of JAK inhibitors will help to adequately weigh the risk/benefit ratio of this drug class.”
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The researchers investigated the safety profile of 4 JAK inhibitors—tofacitinib (Xeljanz), upadacitinib (Rinvoq), baricitinib (Olumiant), and the investigational drug filgotinib—in patients with IBD and other IMIDs (eg, rheumatoid arthritis and psoriasis). The study’s primary outcome was incidence rates of adverse events (AEs) and serious adverse events (SAEs). The final analysis included 82 studies compromising 66,159 patients. Two-thirds of the included studies were randomized controlled trials.
The researchers found the incidence rates of AEs and SAEs were 42.65 per 100 person-years and 9.88 per 100 person-years, respectively. They also estimated incidence rates for mortality (0.37 per 100 person-years), serious infections (2.81 per 100 person-years), herpes zoster infection (2.67 per 100 person-years), malignancy (0.89 per 100 person-years), and major cardiovascular events (0.48 per 100 person-years).
While other AEs were not increased among patients treated with JAK inhibitors, the researchers found a significant increased risk of herpes zoster in these patients (relative risk, 1.57; 95% CI, 1.04-2.37).
“Herpes zoster and serious infections seem to be rather common among these patients, whereas the incidence of malignancy and MACE [major adverse cardiovascular events] seem to be low, and relation to therapy remains to be confirmed,” the researchers concluded. “More studies with long follow-up and in the real-world setting, in the different conditions will be needed to fully elucidate the safety profile of the different JAK inhibitors.” —Eileen Koutnik-Fotopoulos
Olivera P, Lasa J, Bonovas S, Danese S, Peyrin-Biroulet L. Safety of Janus kinase inhibitors in patients with inflammatory bowel diseases or other immune-mediated diseases: a systematic review and meta-analysis [published online January 8, 2020]. Gastroenterology. doi:10.1053/j.gastro.2020.01.001