Currents: Therapeutic Updates

New Guidelines from AAD Address Comorbidities of AD

The American Academy of Dermatology (AAD) has released new guidelines to address comorbidities associated with atopic dermatitis (AD). They cover the burden of AD at the patient- and population-level.

AD is associated with potentially significant impacts on the quality of life or pediatric and adult patients. The guidelines reference accumulating evidence that associated comorbidities increase the burden of the chronic skin disease.

Specifically in adults, comorbidities associated with AD include certain allergic, atopic, immune-mediated conditions, mental health impacts, and bone health effects. Skin infections are also increased among patients with AD. Furthermore, the guidelines cite evidence supporting an association between AD in adults and substance use, attention deficit hyperactivity disorder (ADHD), and elements of metabolic syndrome.

Published in the Journal of the American Academy of Dermatology (JAAD), the guidelines are the first in a four-part series. Additional sections will address topical therapies, phototherapy/systemic interventions, and pediatrics.

New Analysis Ranks Tremfya Highest Among PsA Treatments for Skin Clearance

Tremfya (guselkumab) ranks highest for skin clearance, based on Psoriasis (PsO) Area Severity Index (PASI) 90 response, among 23 psoriatic arthritis (PsA) treatment regimens, results of a newly reported Network Meta-Analysis (NMA) show. In terms of joint inflammation improvement, both Tremfya dosing regimens (100mg every four weeks and every eight weeks) were comparable to most other treatments for the modified van der Heijde-Sharp (vdH-S) score, and Tremfya was generally comparable to TNFi and most IL-17Ai for American College of Rheumatology (ACR) 20 response.

The analysis also confirmed the established safety profile of Tremfya in active PsA. The analysis, presented at the Maui Dermatology 2022 Meeting and reported by Janssen, includes all advanced therapies approved for active PsA (15 unique treatments including IL-23 inhibitors like Tremfya and risankizumab, subcutaneous [SC] tumor necrosis factor inhibitors [TNFi], and Janus kinase inhibitors [JAKi]), using data from 33 Phase 3 randomized clinical trials.

NMA is a structured, protocol-driven analytical process widely accepted and utilized by regulatory agencies, health technology assessment agencies, and medical guideline committees to comparatively evaluate treatment options where head-to-head data are limited or unavailable. It is the most cited and the most comprehensive method available to compare studies indirectly; however, NMAs cannot replace and should not be considered the same as head-to-head clinical trials. In this NMA, the timing of primary endpoint assessment varied across RCTs, and placebo was used as the reference treatment throughout with the exception of two head-to-head studies. Baseline risk adjustment was used to account for heterogeneity across study populations. The NMA builds on previous analyses, including a 2021 publication in Rheumatology, and now incorporates all recent clinical data updates, including the COSMOS study of Tremfya in PsA patients who had an inadequate response to TNFi, as well as data for two new comparators, the IL-23i risankizumab and the JAKi upadacitinib.

Skyrizi Wins Psoriatic Arthritis Indication

Skyrizi (risankizumab-rzaa) from AbbVie is now approved for the treatment of adults with active psoriatic arthritis (PsA). FDA approval is supported by data from two pivotal studies, KEEPsAKE-1 and KEEPsAKE-2, that evaluated the efficacy and safety of Skyrizi in adults with active PsA, including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying antirheumatic drugs (DMARDs).

Across the two Phase 3 studies, SKYRIZI met the primary endpoint of ACR20 response at week 24 compared to placebo and demonstrated significant improvements across several other manifestations of PsA, including swollen, tender and painful joints.

The dosing regimen for Skyrizi for PsA is consistent with the existing regimen for moderate to severe plaque psoriasis patients—a 150mg subcutaneous injection four times a year (after two starter doses at weeks 0 and 4)—and can be administered alone or in combination with DMARDs.

FDA Approves Pfizer’s Cibinqo for Moderate to Severe AD in Adults

Pfizer’s Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, is now FDA approved for the treatment of adults with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

Read more about Cibinqo’s approval and the data to support it here.

Rinvoq APPROVED for Adults, Children 12+ with Refractory, Moderate to Severe AD

The FDA has given its nod to AbbVie’s Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended.

The JAK inhibitor is already approved for the treatment of rheumatoid arthritis and psoriatic arthritis.

Read more about Rinvoq’s approval and the data to support it here.

Desert Harvest’s Aloe Glide Receives NEA Seal of Acceptance

Desert Harvest’s Aloe Glide has received the National Eczema Association (NEA) Seal of Acceptance, making it the first sexual lubricant to earn this seal.

“Aloe Glide is Desert Harvest’s second product to receive the NEA Seal of Acceptance,” says Desert Harvest Chief Executive Officer Heather Florio, in a news release. “We are honored that it has been recognized by the NEA, and that we can be of help to those with sensitive skin and eczema.”

Aloe Glide is compatible with latex and polyisoprene condoms, and is currently the only aloe vera-based sexual lubricant without sodium benozate, a preservative that can cause skin irritation and vaginal pH imbalance. It is free of perfumes and dyes, easy to use, and requires no sticky clean up.

New Positive Patient Satisfaction Data for Tapinarof in Adults with Plaque Psoriasis

Results from a patient satisfaction questionnaire in the long-term, open-label Phase 3 PSOARING 3 extension study of tapinarof cream 1% once daily for the treatment of plaque psoriasis in adults show consistent high rates of satisfaction and positive perception of treatment with tapinarof across all patient-relevant parameters, including patient satisfaction with treatment efficacy, formulation elegance, ease of application, impact on daily life and preference for tapinarof versus prior psoriasis therapies. Dermavant Sciences presented the results during the 2022 Winter Clinical Dermatology Conference last month in Koloa, HI.

Responses to the questionnaire, which were assessed at study completion (week 40 or early termination), demonstrated consistent high rates of satisfaction across all evaluated parameters. Of the 78.5 percent (599/763) of patients from PSOARING 3 who completed the survey:

Patients preferred tapinarof to prior topical treatments with 81.7 percent considering it more effective.

85.8 percent either strongly agreed or agreed they could easily manage their psoriasis with tapinarof.

82.5 percent expressed that they would use tapinarof again or continue using it if available.

In August 2021, the FDA accepted a New Drug Application for tapinarof for the treatment of plaque psoriasis in adult patients and assigned a Prescription Drug User Fee Act target action date in Q2 2022.