AbbVie’s Skyrizi FDA Approved for Psoriasis

Skyrizi (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor from AbbVie, is FDA approved for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. In clinical trials, Skyrizi produced high rates of durable skin clearance with 82 and 81 percent of treated patients in two trials, respectively, achieving PASI 90 at one year. The majority (56 and 60 percent, respectively) achieved complete skin clearance or PASI 100.

“The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals,” said Kenneth B. Gordon, MD, a principal investigator for the ultIMMa-1 pivotal trial and professor and chair of dermatology at the Medical College of Wisconsin. “In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one year. I’m pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response.”

Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of Skyrizi globally.

Read more about the data and clinical implications in this edition, on here and here.

FDA Approves Ortho Dermatologics’ Duobrii for Treatment of Plaque Psoriasis

The FDA has approved Ortho Dermatologics’ New Drug Application for Duobrii (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, indicated for the topical treatment of plaque psoriasis in adults. Duobrii is the only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in a single formulation.

“With today’s approval of Duobrii, patients suffering from plaque psoriasis now have an innovative topical treatment option that uniquely combines two well-known ingredients, halobetasol propionate and tazarotene, with established safety profiles, into a single lotion featuring dual mechanisms of action,” says Bill Humphries, president, Ortho Dermatologics, in a release. “Since psoriasis is a chronic skin disease, patients require continuous treatment in order to achieve optimal control of their symptoms. Now with Duobrii, health care professionals and their patients have a new topical treatment option that can help them achieve those long-term goals. As a result, we believe that Duobrii has the potential to delay some patients from switching to more expensive biologic treatments, which could potentially result in health care savings.”

Duobrii is priced at $825 for a 100-gram tube. Through the company’s access program, most eligible, commercially insured patients will have a co-pay between $25 and $40.

Read more about the formulation on here.

National Psoriasis Foundation Elects New Leaders to Board of Directors

To recognize their dedication in helping people with psoriasis and psoriatic arthritis as volunteers, members, and donors, the National Psoriasis Foundation (NPF) elected Jerry Bagel MD, MS of East Windsor, NJ, Mike Refermat of San Diego, CA, and Jodi Wood of San Antonio, TX to its Board of Directors.

Dr. Bagel is Director of the Psoriasis Treatment Center of Central New Jersey and is affiliated with Penn Medicine Princeton Medical Center. He received his medical degree from Icahn School of Medicine at Mount Sinai and has been in practice for more than 30 years. Dr. Bagel has worked with NPF for more than 15 years and is a four-term member of the Foundation’s medical advisory board.

Dr. Bagel will join NPF’s research and outreach committees. Dr. Bagel is also a member of Practical Dermatology® magazine’s editorial board.

Mr. Refermat is a retired executive with 39 years of experience in various financial, accounting and business leadership capacities. Living with psoriasis and psoriatic arthritis, Mr. Refermat became involved with the NPF in 1986 and has served as the San Diego Community Division chair since 2010 and supported numerous NPF events. In 2018, Mr. Refermat was a Team NPF Cycle captain in San Diego and most recently served on the NPF Strategic Planning Task Force.

Ms. Wood’s son, Michael, was diagnosed with Psoriatic Arthritis at age 12; in 2018 Ms. Wood was diagnosed with the disease as well. Through Michael’s involvement with NPF as a Junior Ambassador, Ms. Wood became an advocate to help those living with psoriasis and psoriatic arthritis gain better access to medications and provide doctors more say in how they treat their patients. Ms. Wood is now the chair of NPF’s advocacy committee.

Dr. Bagel, Mr. Refermat, and Ms. Wood will help direct the NPF by determining goals, evaluating and approving long-term plans, and by working closely with NPF President and CEO, Randy Beranek to accomplish the organization’s overall goals.

High Costs Come with Biologic Switching

Switching or discontinuing biologics is a costly proposition, according to an analysis of data for 8,710 patients with psoriasis. While the majority of patients on biologics were found to be non-switchers (57.4 percent), nearly one-third (31.1 percent) of patients were discontinuers and 11.5 percent were switchers.

Discontinuers had lower mean total healthcare costs, due to reduced prescription costs, but they hay had higher mean medical costs than nonswitchers.

Compared to nonswitchers, switchers had higher adjusted mean total health care costs of $10,120, driven by increased prescription costs and medical costs.

Switchers and discontinuers had more emergency department and inpatient visits than nonswitchers.

Authors conclude, “These updated findings highlight the clinical and economic effects of discontinuing or switching biologic therapies in patients with psoriasis in clinical practice and may inform treatment and/or formulary decision making.”

The study appears in Journal of Managed Care and Specialty Pharmacy (25(4):479-488).