In the Journals

JAK inhibitors may increase risk for herpes zoster in patients with IBD

Patients with inflammatory bowel disease and other immune-mediated diseases who receive Janus kinase inhibitors may be at increased risk for herpes zoster infection, according to the results of a meta-analysis.

Laurent Peyrin-Biroulet, MD, PhD, of the department of hepatogastroenterology at Nancy University Hospital in France, and colleagues wrote that as the number of new treatments for IBD grows, decisions about how to position them become more difficult.

“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,” they wrote. “Knowing the exact safety profile of JAK inhibitors will help to adequately weigh the risk/benefit ratio of this drug class.”

The researchers sought to investigate the safety profile of several JAK inhibitors — including Xeljanz (tofacitinib, Pfizer) and Rinvoq (upadacitinib, AbbVie) — in patients with IBD and other immune-mediated disease, like rheumatoid arthritis. The primary outcome of the study was incidence of adverse events and serious adverse events.

Peyrin-Biroulet and colleagues included 82 studies comprising 66,159 patients in their analysis. The incidence rate of adverse events was 42.65 per 100 person-years, while the incidence rate for serious adverse events was 9.88 per 100 person-years. They also estimated the incidence rates for serious infection (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 adverse events were not increased among patients who received JAK inhibitors, researchers found that these patients were at increased risk for herpes zoster infection (RR = 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 [major adverse cardiovascular events] seem to be low, and relation to therapy remains to be confirmed,” Peyrin-Biroulet and colleagues wrote. “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.” – by Alex Young

Disclosure: Peyrin-Biroulet reports receiving honoraria from AbbVie, Alma, Allergan, Amgen, Arena, Biogen, Boerhinger Ingelheim, Celgene, Celltrion, Enterome, Ferring, Genentech, Gilead, Hikma, Index Pharmaceuticals, Janssen, MSD, Nestle, Pfizer, Pharmacosmos, Roche, Samsung Bioepis, Sandoz, Sterna, Takeda and Tillots. He also reports receiving grants from AbbVie, MSD and Takeda, and he has stock options for CT-SCOUT. Please see the full study for all other authors’ relevant financial disclosures.

Patients with inflammatory bowel disease and other immune-mediated diseases who receive Janus kinase inhibitors may be at increased risk for herpes zoster infection, according to the results of a meta-analysis.

Laurent Peyrin-Biroulet, MD, PhD, of the department of hepatogastroenterology at Nancy University Hospital in France, and colleagues wrote that as the number of new treatments for IBD grows, decisions about how to position them become more difficult.

“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,” they wrote. “Knowing the exact safety profile of JAK inhibitors will help to adequately weigh the risk/benefit ratio of this drug class.”

The researchers sought to investigate the safety profile of several JAK inhibitors — including Xeljanz (tofacitinib, Pfizer) and Rinvoq (upadacitinib, AbbVie) — in patients with IBD and other immune-mediated disease, like rheumatoid arthritis. The primary outcome of the study was incidence of adverse events and serious adverse events.

Peyrin-Biroulet and colleagues included 82 studies comprising 66,159 patients in their analysis. The incidence rate of adverse events was 42.65 per 100 person-years, while the incidence rate for serious adverse events was 9.88 per 100 person-years. They also estimated the incidence rates for serious infection (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 adverse events were not increased among patients who received JAK inhibitors, researchers found that these patients were at increased risk for herpes zoster infection (RR = 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 [major adverse cardiovascular events] seem to be low, and relation to therapy remains to be confirmed,” Peyrin-Biroulet and colleagues wrote. “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.” – by Alex Young

Disclosure: Peyrin-Biroulet reports receiving honoraria from AbbVie, Alma, Allergan, Amgen, Arena, Biogen, Boerhinger Ingelheim, Celgene, Celltrion, Enterome, Ferring, Genentech, Gilead, Hikma, Index Pharmaceuticals, Janssen, MSD, Nestle, Pfizer, Pharmacosmos, Roche, Samsung Bioepis, Sandoz, Sterna, Takeda and Tillots. He also reports receiving grants from AbbVie, MSD and Takeda, and he has stock options for CT-SCOUT. Please see the full study for all other authors’ relevant financial disclosures.