Biologics Offer Range of Options for Dermatologists Looking to Treat Patients

Biologics are offering an array of options for dermatologists looking for something different for their patients, and recently-released data show their promise for treating hidradenitis suppurativa (HS), according to a presenter at the Winter Clinical Dermatology Conference, held January 14 to 19, in Kauai, Hawaii.¹

April Armstrong, MD, MPH, of the University of Southern California, discussed the results from two phase 3 studies of the possible new indication for secukinumab (Cosentyx; Novartis), which showed the potential for these agents in treating these patients. Bimekizumab (Bimzelx, UCB) is also in clinical trials for the off-label treatment in these patients.

In an investor event held in December 2021, Novartis presented data that indicated two phase 3 studies, Sunrise (NCT03713632) and Sunshine (NCT03713619) met their primary end points, with more patients treated with Cosentyx achieving a clinical response compared with placebo 4 months into the trial, Armstrong said, citing a company release.2 She added that the safety of the biologic in HS was consistent with the therapy’s known safety profile. The trials are continuing to 52 weeks and are expected to be complete in the second quarter of 2022.²

Armstrong also noted biologics’ use in patients with psoriasis and psoriatic arthritis, with the FDA approving as many as 11 biologics for the treatment of these conditions. She said that bimekizumab has demonstrated dual specificity for inhibiting IL-17A and IL-17F. Additionally, she said, in trials, 90% of patients showed 90% improvement, or PASI n90, to patients by week 16, offering another potential treatment option for these patients.

She cited data that looked at the safety of bimekizumab for patients with oral candidiasis that showed at 2 years, most patients did note 1 or 2 adverse events, however, they resolved with continued treatment and did not discontinue the study, she said.³

There have been advances in using biologics for patients with pemphigus vulgaris, Armstrong said, noting data on rituximab (Rituxan; Genentech), which demonstrated 90% complete remission in an efficacy trial using a 2-dose regimen of IV infusions that was approved in Europe, separated by 2 weeks with a short-term steroid compared with steroid only.⁴

According to company-presented data, by the end of a 2-year study of 74 adults, after 2 years, 9 out of 10 people taking rituximab plus short-term steroids had no lesions compared with 28% who took steroids only.

Armstrong also discussed data relating to efgartigimod (ARGX-113, Vyvgart; Argenx), an antibody fragment targeting neonatal Fc receptor, which was recently approved by the FDA to treat generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive. She said this treatment also may offer an option for patients with pemphigus vulgaris in the future, but further research is needed.⁵

“There are lots of developments in the realm of biologics and lots more to come,” Armstrong concluded.

References:

1. Armstrong AW. What's new and hot in biologics. Presented at: Winter Clinical Dermatology Conference-Hawaii 22. January 14-19, 2022. Kauai, HI.
2. Novartis R&D day spotlights attractive growth profile, underpinned by strong in-market brands, 20 potential high value pipeline assets, and technology platforms. Novartis. Press release. Published December 2, 2021. Accessed January 15, 2022. https://www.novartis.com/node/83456/printable/print
3. Freitas E, Torres T. Bimekizumab: the new drug in the biologics armamentarium for psoriasis. Drugs in Context. 2021;10:1-4. doi: 10.7573/dic.2021-4-1.
4. Chen DM, Odueyungbo A, Csinady E, et al. Rituximab is an effective treatment in patients with pemphigus vulgaris and demonstrates a steroid‐sparing effect. Br J Dermatol. 2020;182(5):1111-1119.
5. FDA approves new treatment for myasthenia gravis. FDA. Press release. Published December 17, 2021. Accessed January 15, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-myasthenia-gravis