To the Editor: With the peak of coronavirus disease 2019 (COVID-19) expected to occur in many regions of the United States in the coming weeks to months, physicians and patients alike are concerned about the use of immunosuppressive, biologic agents given the increased infection risk. A recent Letter to the Editor highlighted the risk of total infections, upper respiratory tract infections, and nasopharyngitis in patients with psoriasis on immunomodulating biologic therapy.1
Similar to psoriasis, hidradenitis suppurativa (HS) is an inflammatory skin disease managed effectively with biologic agents when disease burden is high. Adalimumab, a tumor necrosis factor-α inhibitor, is currently the only United States Food and Drug Administration (FDA)-approved drug for moderate to severe HS. Compared with patients with psoriasis, patients with HS generally require higher doses of adalimumab, especially during treatment initiation.2 Although current data are not available for COVID-19 risk in patients with HS, data from the Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa (PIONEER) I and II phase 3 clinical trials may provide important insight into the risk of infectious complications in this unique patient population.3
Table I highlights the risk of total infections, upper respiratory tract infections, and pharyngitis in patients with HS on adalimumab vs placebo from the data published in the PIONEER I and II trials.3 In patients with HS taking adalimumab, there is a modest increased risk of total infections and nasopharyngitis by 2.5%, on average, with no difference in the risk of upper respiratory tract infections. These results demonstrate that, in general, there was minimal difference between rates of respiratory infections in patients with HS on adalimumab vs placebo.
Table I.
Risks of total infections, upper respiratory infections, and nasopharyngitis in hidradenitis suppurativa patients taking adalimumab vs placebo∗
| Trial | Patients, No. |
Total infections, No. (%) |
Upper respiratory tract infections, No. (%) |
Nasopharyngitis, No. (%) |
||||
|---|---|---|---|---|---|---|---|---|
| Adalimumab | Placebo | Adalimumab | Placebo | Adalimumab | Placebo | Adalimumab | Placebo | |
| PIONEER I | 152 | 153 | 40 (26) | 32 (21) | 4 (2.6) | 5 (3.3) | 16 (10.5) | 9 (5.9) |
| PIONEER II | 163 | 163 | 37 (23) | 36 (22) | 9 (5.5) | 8 (4.9) | 10 (6.1) | 9 (5.5) |
| Total | 315 | 316 | 77 (24) | 68 (21.5) | 13 (4.1) | 13 (4.1) | 26 (8.2) | 18 (5.7) |
Data from period 1 of the Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa (PIONEER) I and II trials.
Much like data regarding the effect of immunosuppressive drugs on patients with psoriasis, extrapolating data from the PIONEER I and II trials to susceptibility to coronavirus infection is difficult. Nonetheless, dermatologists may use these data to make informed treatment decisions for patients with HS during the ongoing COVID-19 pandemic.
Footnotes
Funding sources: None.
Conflicts of interest: None disclosed.
IRB approval status: Not applicable.
References
- 1.Lebwohl M., Rivera-Oyola R., Murrell D.F. Should biologics for psoriasis be interrupted in the era of COVID-19? J Am Acad Dermatol. 2020;82(5):1217–1218. doi: 10.1016/j.jaad.2020.03.031. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.United States Food and Drug Administration . 2015. Adalimumab [package insert] Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125057s394lbl.pdf. Accessed April 27, 2020. [Google Scholar]
- 3.Kimball A.B., Okun M.M., Williams D.A., et al. Two phase 3 trials of adalimumab for hidradenitis suppurativa. N Engl J Med. 2016;375(5):422–434. doi: 10.1056/NEJMoa1504370. [DOI] [PubMed] [Google Scholar]