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Biologic Treatments

Select Treatments:
  • What is it and how does it work?
  • Who is this for?
  • Who is this not for?
  • How well does it work?
  • What are the possible side effects?
  • Will it inconvenience me?

Biologic Treatments

What is it and how does it work?

Tumor necrosis factor alpha (TNFα) inhibitors

Adalimumab (Humira)

Adalimumab is a protein that targets a protein involved in inflammation, TNFα (Zouboulis, et al., 2015).

It can be self-injected by patients at home (Hidradenitis Suppurativa Foundation, Inc.).

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Adalimumab is a human monoclonal antibody corresponding to the human immunoglobulin IgG1, which binds to TNFα and neutralizes its inflammatory activity (Zouboulis, et al., 2015).

Other TNFα inhibitors

Infliximab (Remicade, Renflexis)

Infliximab is administered intravenously (Hidradenitis Suppurativa Foundation, Inc.) and may be used as an alternative TNFα inhibitor to adalimumab (Saunte & Jemec, 2017). The contraindications, side effects, and monitoring parameters listed above for adalimumab are similar to those for infliximab.

Etanercept (Enbrel)

Limited conflicting data does not support its use in HS patients.

Golimumab (Simponi, Simponi Aria)

Golimumab can be administered subcutaneously or intravenously.

IL-1 receptor inhibitors

Anakinra (Kineret)

Anakinra is a protein that binds to and blocks interleukin-type I (IL-1) receptors involved in inflammation (Lee & Eisen, 2015). It is self-injected daily by patients at home (Hidradenitis Suppurativa Foundation, Inc.). Consider only after failing to respond to treatment with TNFα inhibitors (Alikhan, et al., 2019).

IL-12/IL-23 inhibitors

Ustekinumab (Stelara)

Ustekinumab is a human antibody that blocks the effects of two proteins involved in inflammation, interleukin-12 (IL-12) and interleukin-23 (IL-23). It may be self-injected at home or the dermatologist’s office (Hidradenitis Suppurativa Foundation, Inc.).

Who is this for?

Tumor necrosis factor alpha (TNFα) inhibitors

Those with moderate to severe HS (Zouboulis, et al., 2015).

Who is this not for?

Tumor necrosis factor alpha (TNFα) inhibitors

Those with allergies to adalimumab; with severe infections, multiple sclerosis, or heart failure (Lexicomp).

Those younger than 2 years (Drugs.com).

Caution should be taken in those:

  • Taking drugs that reduce immune responses, (i.e. methotrexate or corticosteroids);
  • Of older age;
  • With conditions (i.e. diabetes) that predispose to infections;
  • Who live in or travel to areas where infections are present;

How well does it work?

Tumor necrosis factor alpha (TNFα) inhibitors

Level of Evidence: Level I

Strength of recommendation: “A” rating

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Two 12-week phase 3 trials (N=307 in PIONEER 1 and N=326 in PIONEER 2) showed better response to adalimumab vs. placebo (42% vs. 26% in PIONEER 1 and 59% vs. 28% in PIONEER 2) (Kimball, et al., 2016).

Other TNFα inhibitors

Infliximab (Remicade, Renflexis)

Level of Evidence: Level II

Strength of recommendation: “B” rating

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At week 8, greater improvement was observed in moderate to severe HS patients randomized to infliximab (N=15) vs. placebo (N=18).

Placebo patients who crossed over to the infliximab group from weeks 8 to 16 improved similarly to those treated with infliximab from weeks 0 to 8 (Grant, Gonzalez, Montgomery, Cardenas, & Kerdel, 2010).

Etanercept (Enbrel)

Level of Evidence: Level II

Strength of recommendation: “C” rating

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Moderate to severe HS patients were randomized to etanercept (N=10) or placebo (N=10) for 12 weeks. All received etanercept for another 12 weeks. No significant improvement between groups was reported at 12 or 24 weeks (Adams, Yankura, Fogelberg, & Anderson, 2010). Other studies reported mixed results.

Golimumab (Simponi, Simponi Aria)

Level of Evidence: Level III

Strength of recommendation: “C” rating

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A case reported that HS deteriorated in a female treated with golimumab for 8 months, while lesions disappeared within two months in another case (van der Zee & Prens, 2013; Tursi, 2016).

IL-1 receptor inhibitors

Anakinra (Kineret)

Level of Evidence: Level II

Strength of recommendation: “B” rating

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Hurley stage II or III HS patients were randomized to anakinra or placebo for 12 weeks. Better responses were observed in a larger proportion of those treated with anakinra (7 of 10) vs. placebo (3 of 10) (Tzanetakou, et al., 2016). Other studies reported mixed results.

IL-12/IL-23 inhibitors

Ustekinumab (Stelara)

Level of Evidence: Level II

Strength of recommendation: “B” rating

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47% of 17 Hurley stage II or III HS patients who received ustekinumab at weeks 0, 4, 16, and 28 improved (Blok, Li, Brodmerkel, Horvátovich, Jonkman, & Horváth, 2016). Other studies reported mixed results.

What are the possible side effects?

Tumor necrosis factor alpha (TNFα) inhibitors

Serious: Severe infections, cancers, liver damage, immune system disorders, nerve problems (Lexicomp). The use of adalimumab has also been associated with specific cancers in those with Crohn’s disease or ulcerative colitis (Lexicomp).

Other: Headache, nausea, abdominal pain, allergic reaction(s) at the injection/infusion site (Lexicomp).

Pregnancy risk according to the U.S. Food and Drug Administration (FDA):

  • Category B
  • Although no fetal risks have been reported during pregnancy or breastfeeding, its safety remains unclear (Perng, Zampella, & Okoye, 2017).
  • Pregnant adalimumab users should avoid vaccinating their infants for at least 6 months after birth (Lexicomp).

Will it inconvenience me?

Tumor necrosis factor alpha (TNFα) inhibitors

A blood draw will need to be performed to test for Hepatitis B virus (HBV) and tuberculosis before starting the medication (epocrates).

Skin examinations should be performed, especially in those with increased risk of skin cancer (epocrates).

Adalimumab users should avoid receiving “live” vaccines, as serious infections may develop (Lexicomp).

All recommended vaccines should be current before taking adalimumab (Lexicomp). Non-live influenza vaccination is still recommended annually while on biologics.