key: cord-347293-fp8phk0p
authors: Kearns, Donovan G.; Chat, Vipawee S.; Uppal, Shelley; Wu, Jashin J.
title: Assessing The Risk of Adalimumab Use For Hidradenitis Suppurativa During The COVID-19 Pandemic
date: 2020-07-28
journal: J Am Acad Dermatol
DOI: 10.1016/j.jaad.2020.07.086
sha: 
doc_id: 347293
cord_uid: fp8phk0p

nan

Despite prolonged quarantines and social restrictions, the COVID-19 pandemic continues to persist in the United States and globally. Questions still remain regarding the safety of various immunosuppressive medications for those with chronic conditions. With limited real-life data from COVID-19 infection in patients with hidradenitis suppurativa (HS) receiving adalimumab, we can use previous drug trials to extrapolate the potential risk to patients, based upon the change in infection rate when compared to placebo.

Adalimumab, a tumor necrosis factor alpha (TNF-α) antagonist, is the only FDA approved biologic treatment for patients >12 years with for moderate to severe HS. TNF-α is a pleiotropic cytokine with pro-inflammatory functions that serves to protect against bacterial, fungal and viral infection. Primary infection or reactivation of HIV, varicella zoster virus, Epstein-Barr virus, hepatitis, cytomegalovirus, JC and human papillomavirus have all been reported in patients receiving TNF-α therapy. 1 TNF-α has been shown to be significantly elevated in patients with the SARS-CoV-2 infection, and serum levels are positively correlated with disease severity. 2 It is currently uncertain whether elevated TNFα is necessary for resolution of SARS-CoV-2 infection or if it plays a pathological role in the development of "cytokine storm".

In two placebo-controlled phase III clinical trials (PIONEER I/II), 633 adults with moderate-tosevere HS were randomized to receive adalimumab (40 mg), or placebo. The trials were divided into two periods. In period 1, patients' receiver either 40 mg of adalimumab weekly (QW) or placebo for 12 weeks. In period 2, patients received adalimumab (40 mg) weekly, every-otherweek (Q2W) or placebo for 24 weeks. At the end of period 1, infection developed in 24.8% and 25.2% of those receiving adalimumab QW, compared to 28.3% and 32.5% of patients receiving placebo, in PIONEER 1 and 2, respectively. At the end of period 2, infection occurred in 29.2% and 35.3% of patients receiving adalimumab QW, 25.0 and 35.8 of patients receiving the medication Q2W and 32.7 and 25.5% of patients in the placebo control group, in PIONEER 1 and 2, respectively. 3 There was no increase in serious infection or nasopharyngitis observed in active treatment groups. In both trials, it was concluded that the rate of infection was not increased in adalimumab-treated patients compared to placebo ( Table 1) .

This study's analysis was limited by the original research from the adalimumab trials, as the authors of the trials did not specify the whether the cause of infection was bacterial or viral. However, the findings support the notion that healthy HS patients, without risk factors, who use adalimumab during the COVID-19 pandemic are not predisposed to infection or nasopharyngitis ( Table 1) . This is consistent with a recent case series documenting mild, uncomplicated disease in a small cohort of HS patients receiving adalimumab. 4 Clinicians considering discontinuing adalimumab in high-risk patients should be aware that discontinuation of biologics has been shown to result in decreased response to treatment and the development of antidrug antibodies. *This data is a combined average of two-phase III trials. The adalimumab group is a combined average of two treatment schedules (once per week or once per two weeks)

Tumor necrosis factor blockade and the risk of viral infection

Clinical features of patients infected with 2019 novel coronavirus in Wuhan

Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa

Experience in patients with hidradenitis suppurativa and COVID-19 symptoms