Biologic Treatment for Hidradenitis Suppurativa

Kelsey S. Flood; Martina L. Porter; Alexa B. Kimball

Disclosures

Am J Clin Dermatol. 2019;20(5):625-638. 

In This Article

Biologics Targeting IL-12 and IL-23

Expression of IL-12 and IL-23 mRNA is elevated in lesional HS skin.[18,75] In contrast, one study reported no significant difference in IL-12 levels in HS compared with healthy control skin.[2]

Ustekinumab

Ustekinumab is a monoclonal antibody with activity against P40, a subunit of both IL-12 and IL-23.[76] Commonly used dosing of ustekinumab in HS patients is similar to the psoriasis regimen (45 mg of ustekinumab or 90 mg if the subject weighs > 100 kg, with induction phase dosing at weeks 0 and 4 followed by a maintenance phase with additional dosing at weeks 16 and 28[77] (Table 1).

Few studies exist that examine the efficacy of ustekinumab in HS. An open-label, prospective study of 17 patients (of whom 12 completed the protocol) found that 47% of patients achieved HiSCR-50 and 82% of patients obtained either a moderate or marked improvement of the mSS score after treatment with ustekinumab.[77] In a review of three patients with moderate-to-severe HS treated with ustekinumab (45 mg subcutaneously at 0, 1, and 4 months), one patient demonstrated complete remission whereas another patient developed new HS lesions in addition to several adverse effects during treatment. The third patient initially demonstrated improvement, which was followed by a recrudescence in his HS. This later responded to antibiotics and increased dosing of ustekinumab to 90 mg.[78] Case reports in the literature have reported durable efficacy. In one case report, a 50-year-old female treated with ustekinumab was, at the time of writing, without active lesions after 1.5 years of treatment. Her course on ustekinumab was complicated by two exacerbations managed with antibiotics and steroids.[79] In another case of a patient with concurrent psoriasis, Bechet's disease, and HS who underwent treatment with ustekinumab for her psoriasis, treatment led to gradual improvement and later remission of her HS for 3 years.[80]

Other Agents Targeting IL-23

Guselkumab is a monoclonal antibody with activity against IL-23 that is currently used in psoriasis.[81,82] A phase II clinical trial to assess the use of guselkumab in HS, in different dosing regimens including both intravenous and subcutaneous guselkumab, is currently recruiting[83] (Table 3). Risankizumab is another IL-23 antagonist approved for psoriasis.[84] A phase II study studying risankizumab in moderate-to-severe hidradenitis suppurativa is planned but not yet recruiting.[85]

Safety Concerns

In a recent study from PSOLAR, incidence rates of various adverse events were studied in patients with psoriasis treated with ustekinumab. The authors reported the following incidence rates: malignancy 0.68/100 patient-years (PY), major adverse cardiac events 0.33/100 PY, serious infection 1.60/100 PY, and mortality 0.46/100 PY.[86] In a meta-analysis of six randomized controlled trials assessing use of ustekinumab for plaque psoriasis, no statistically significant difference was seen in adverse effects when comparing those patients treated with placebo, ustekinumab 45 mg, and ustekinumab 90 mg, except in regard to infection. Patients treated with ustekinumab 45 mg had a higher rate of infection compared with placebo.[87] Other adverse events associated with ustekinumab use can be found in Table 1. As it is more targeted in its immunologic inhibition, it appears that ustekinumab may have fewer safety concerns than TNF inhibitors. However, further data is needed before formal conclusions can be made.

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