Multiple biologics supported in new psoriasis guidelines

Feb 25, 2019, 12:00am

New guidelines from the American Academy of Dermatology and the National Psoriasis Foundation strongly support the use of a wide range of biologics to treat cases of psoriasis that are insufficiently resolved despite treatment with topical therapy, phototherapy or both. 

New guidelines strongly support the use of a wide range of biologics to treat cases of psoriasis that are insufficiently resolved despite treatment with topical therapy, phototherapy or both. 

"Biologic agents, as monotherapy or combined with other topical or systemic medications, have a high benefit-to-risk ratio, and because of that, they are a welcome addition to the armamentarium of psoriasis management," write the authors of the joint guidelines for the American Academy of Dermatology and the National Psoriasis Foundation.

The guidelines, which provide recommendations about biologics therapy for psoriasis, were published online Feb. 13 in the Journal of the American Academy of Dermatology. (https://doi.org/10.1016/j.jaad.2018.11.057)

University of Alabama at Birmingham professor of dermatology Craig A. Elmets, MD, FAAD, co-chair of the work group that developed the joint guidelines, put it this way in an interview with Dermatology Times: "Biologics have revolutionized psoriasis therapy, and many people can have clearing or almost complete clearing of their disease. And many [of the drugs] seem to be safer than alternatives before the biologics such as cyclosporine."

With guidance listed at a "strength of recommendation" of A, guidelines support the monotherapy use of these TNF-alpha inhibitors for moderate-to-severe psoriasis:

  • etanercept (Enbrel)

  • infliximab (Remicade)

  • adalimumab (Humira)

Another TNF-alpha drug, certolizumab (Cimzia), was FDA-approved in 2018 and "is likely to have class characteristics similar to those of other TNF-α inhibitors regarding treatment combination, efficacy in difficult-to-treat areas, and possibly, immunogenicity," the guidelines note. "Nevertheless, there is no evidence available on these topics, and these statements are based on extrapolation of data from other TNF-α inhibitors."

In regard to IL-12/IL-23, IL-17 and IL-23 inhibitors, the guidelines offers "A"-level support for the monotherapy use of these drugs for moderate-to-severe psoriasis:

  • ustekinumab (Stelara)

  • secukinumab (Cosentyx)

  • ixekizumab (Taltz)

  • brodalumab (Siliq)

  • guselkumab (Tremfya)

  • tildrakizumab (Ilumya)

Risankizumab, which is not yet FDA-approved, can also be used in these patients (the strength of recommendation for this guidance is B).

The guidelines suggest that switching biologics can be appropriate if clinically necessary. However, "it is important to stress that not all switches may result in improvement and that, at this time, there are insufficient data to make more specific recommendations."

The guidelines caution that "there is still limited evidence regarding long term-adverse events, impacts on future comorbidities, pediatric treatment, pregnancy and lactation, and treatment combination for many of the newer biologic agents. There is also an important need to identify biomarkers that can potentially predict the appropriate biologic agent for individual patients."

In the big picture, "the need for treating ALL patients with moderate-to-severe psoriasis is essential," said Dallas dermatologist Alan Menter, MD, FAAD, in an interview with Dermatology Times. Dr. Menter is a co-chair of the work group that developed the joint guidelines.

According to work group co-chair Dr. Elmets, future psoriasis guidelines will examine phototherapy pediatric psoriasis, topical agents and non-biologic systemic treatments.

Disclosures:
For the guidelines: no funding is reported

Craig A. Elmets, MD, served as a consultant for Ferndale Laboratories, Inc, receiving honoraria; as a consultant for Vaxin receiving stock and/or stock options; as a consultant/advisory board member for Vertex Pharmaceuticals receiving fees/honoraria; as a principal investigator for the California Association of Winegrape Growers, Kyowa Hakko USA, and Solgenix LLC receiving grants and/or research funding; as an investigator for Elorac, Inc, Idera Pharmaceuticals, Inc, Kyowa Hakko USA, and Solgenix LLC receiving grants and/or research funding; as a data safety monitoring board member for Astellas Pharma US, Inc, and LEO Laboratories, Ltd, receiving fees; as a stockholder for Medgenics, Inc, receiving no fees; and as a stockholder for Aevi Genomic Medicine (receiving stock) and Immunogen (paid to spouse).

Alan Menter, MD, served as a consultant for Abbott Labs, AbbVie, Amgen, Eli Lilly and Company, Galderma USA, Janssen Pharmaceuticals Inc, LEO Pharma US, Menlo Therapeutics, Novartis, Sienna Biopharmaceuticals, and Wyeth Labs receiving honoraria; as a consultant for New Enterprise Associates, Promius Pharma LLC, Spherix Global Insights US, UCB, and Valeant Pharmaceuticals North America receiving fees; as a consultant for Afecta Pharmaceuticals receiving no compensation; as a speaker for Abbott Labs, AbbVie, Amgen, Janssen Biotech, LEO Pharma, US, Pfizer, Inc, Promius Pharma LLC, Sienna Pharmaceuticals, UCB, and Wyeth Labs receiving honoraria; as a principal investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene Corporation, Eli Lilly and Company, Janssen Pharmaceuticals, Inc, Medimetriks Pharmaceuticals, Inc, Merck & Co, Inc, Novartis Pharmaceutical Corp, and Pfizer, Inc, receiving grant and/or research funding; as an investigator for Eli Lilly and Company and UCB receiving honoraria; investigator for Abbott Labs, Leo Pharma US, and Sienna Biopharmaceutical receiving grants; as an advisory board member for Abbott Labs, AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen Pharmaceuticals, Inc, LEO Pharma US, Medscape, Pfizer, Inc, and Sienna Biopharmaceuticals, receiving honoraria; as an advisory board member for Amgen receiving grant and/or research funding; as an advisory board member for Afecta Pharmaceuticals receiving no compensation; and as an independent contractor for Prime Education receiving fees.

Alan Menter, MD,* served as a consultant for Abbott Labs, AbbVie, Amgen, Eli Lilly and Company, Galderma USA, Janssen Pharmaceuticals Inc, LEO Pharma US, Menlo Therapeutics, Novartis, Sienna Biopharmaceuticals, and Wyeth Labs receiving honoraria; as a consultant for New Enterprise Associates, Promius Pharma LLC, Spherix Global Insights US, UCB, and Valeant Pharmaceuticals North America receiving fees; as a consultant for Afecta Pharmaceuticals receiving no compensation; as a speaker for Abbott Labs, AbbVie, Amgen, Janssen Biotech, LEO Pharma, US, Pfizer, Inc, Promius Pharma LLC, Sienna Pharmaceuticals, UCB, and Wyeth Labs receiving honoraria; as a principal investigator for AbbVie, Amgen, Boehringer Ingelheim, Celgene Corporation, Eli Lilly and Company, Janssen Pharmaceuticals, Inc, Medimetriks Pharmaceuticals, Inc, Merck & Co, Inc, Novartis Pharmaceutical Corp, and Pfizer, Inc, receiving grant and/or research funding; as an investigator for Eli Lilly and Company and UCB receiving honoraria; investigator for Abbott Labs, Leo Pharma US, and Sienna Biopharmaceutical receiving grants; as an advisory board member for Abbott Labs, AbbVie, Boehringer Ingelheim, Eli Lilly and Company, Janssen Pharmaceuticals, Inc, LEO Pharma US, Medscape, Pfizer, Inc, and Sienna Biopharmaceuticals, receiving honoraria; as an advisory board member for Amgen receiving grant and/or research funding; as an advisory board member for Afecta Pharmaceuticals receiving no compensation; and as an independent contractor for Prime Education receiving fees.