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Infection Risk of Biologics for Hidradenitis Suppurativa?

– Recent analysis found different risk levels for different drug classes


When used in patients with hidradenitis suppurativa (HS), biologic therapies do not significantly increase infection risk.

That was the conclusion of a recent systematic review and meta-analysis appearing in the .

The analysis included 24 studies, comprising 1,696 patients. The pooled incidence rate for any infection was 24.2%, primarily consisting of mild respiratory and skin infections. This did not differ significantly from placebo.

Infection rates per drug class were: 7.77% for anti-IL-1 agents, 14.24% for anti-PDE4 agents, and 21.96% for anti-TNF agents. IL-17 inhibitors were associated with the highest infection rate at 33.6%, although the relative risk did not differ significantly from placebo (0.99, 95% CI 0.86-1.14).

The international study team was led by researchers with Warren Alpert Medical School of Brown University in Rhode Island. The following paper excerpts have been edited for length and clarity.

What prompted this investigation?

Biologics have emerged as a promising treatment option for HS. Currently, adalimumab is the only biologic treatment approved in the U.S. for HS. Secukinumab was approved by the European Commission in 2023.

Biologic therapies carry a heightened risk of infections. For patients with HS who are already predisposed to infection, it is crucial to carefully weigh the potential risks and benefits of biologics.

Thus, the researchers sought to examine the incidence and severity of infectious complications in patients with HS receiving biologic or other immunomodulator therapies.

What were the key findings?

The risk of any infection among HS patients treated with biologics was 24%, which was not significantly higher than that associated with placebo.

Although not used as first-line treatments, anti-IL-1 agents -- specifically anakinra and bermekimab -- have been tested in patients with HS. In the current study, researchers evaluated the risk of infectious complications based on four anti-IL-1 studies. The findings revealed a 7.77% incidence of any infection, with no occurrence of serious or opportunistic infections.

What about severe or opportunistic infections for all biologics included in the analysis?

Serious infections were rare. Pooled incidences were 0.39% for IL-17 inhibitors and 0.03% for TNF inhibitors.

Opportunistic infections were infrequent. There were ten reported cases, including eight oral candidiasis, one cryptosporidiosis, and one Blastocystis hominis infection.

What are the review's potential implications for biologics as a treatment for HS?

Prior studies demonstrated a greater likelihood of opportunistic infections in patients undergoing long-term anti-TNF therapy. Therefore, these findings could have important clinical implications, researchers wrote, given that only one biologic (adalimumab) is approved in the U.S. for moderate-to-severe HS.

What are the take home messages?

According to investigators, the results indicate that biologics do not significantly increase the risk of infectious complications. Serious and opportunistic infections appeared to be exceedingly rare.

Patients with HS have a higher risk of infection than the general population because of factors including bacterial colonization and dysregulation of the immune system. Comorbidities like diabetes further amplify infection risk. Therefore, it is crucial, the research team concluded, to implement preventive measures such as hepatitis and HIV serologies, tuberculosis screenings, and surveillance, as well as ensuring that patients receive all recommended vaccinations before and during anti-TNF treatment.

No study author disclosed any relevant financial relationship with industry.

Primary Source

International Journal of Dermatology

Source Reference:

AAD Publications Corner

AAD Publications Corner