New molecules and PAD Tech expand treatments for psoriasis and Alzheimer’s disease
In his presentation, “New Drugs and Therapies in 2022” at the current Maui Derm for Dermatologists meeting in Maui, Hawaii, and virtual, Neal Bhatia, MD, highlighted new treatments for atopic dermatitis (AD) and psoriasis entering the new year.1
Bhatia is Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego, California.
Psoriasis and atopic dermatitis
According to Bhatia, PAD technology has shown benefits in topical dermatological therapy, as seen in a new betamethasone and calcipotriene combination treatment in a foam vehicle (Wynzora; MC2 Therapeutics).
PAD technology, according to the MC2 Therapeutics website, allows the mixing of oil and water into a cream using only a fraction of the emulsifier required in conventional creams and lotions.2
In a recent study, researchers found that calcipotriene dipropionate/betamethasone foam applied twice weekly as a proactive management of plaque psoriasis was well tolerated over the 52-week study period and demonstrated a greater efficacy than reactive management in a study cohort of 251 patients.3
“Wynzora cream is the first launch by MC2 with PAD technology allowing stability of the combination of active ingredients for psoriasis and flexibility of use on the body and scalp,” Bhatia said. “The balance between oil and water, as well as the elegance of the vehicle, promotes significant results in terms of compliance and efficiency.”
Patients with moderate to severe AD may benefit from the recently FDA-approved ruxolitinib cream 1.5% (Opzelura; Incyte), the first topical janus kinase (JAK) inhibitor of JAK 1 and JAK 2, has said Bhatia. This new drug may offer patients with moderate to severe AD a good treatment option over commonly used treatments, including topical corticosteroids and calcineurin inhibitors tacrolimus and pimecrolimus, he added. Additionally, the FDA recently approved upadacitinib (Rinvoq; AbbVie)4 and abrocitinib (Cibinqo; Pfizer Inc),5 the first 2 oral JAK 1 inhibitors for the treatment of moderate to severe AD. According to Bhatia, this gives AD patients more treatment options beyond more traditional therapies such as corticosteroids, which he says have issues with long-term use.
“Unlike calcineurin inhibitors which block the neurotransmitter NF-AT with subsequent effects on inflammation, ruxolitinib as a [JAK] The inhibitor works to arrest cytokine progression and processing by preventing receptor dimerization and phosphorylation of STAT proteins that carry messages to the nucleus for transcription,” Bhatia said. “In many ways, the difference is that topical calcineurin inhibitors can mop up the mess of inflammation while JAK inhibitors will turn off the tap to stop the progression of inflammation.”
Roflumilast (ARQ-151, Arcutis Biotherapeutics, Inc) and tapinarof (GSK2894512, Dermavant Sciences, Inc) represent 2 new topical phosphodiesterase type 4 (PDE4) therapies under investigation that have been shown to be effective in AD , psoriasis and seborrheic dermatitis. The once-daily topical formulation of roflumilast cream, foam or lotion is a very potent and selective PDE4 inhibitor, Bhatia said, having good efficacy in AD, psoriasis, seborrheic dermatitis and vitiligo.
Tapinarof is an investigational topical aryl-hydrocarbon receptor modulating agent that decreases oxidative stress and inflammation in psoriasis and Alzheimer’s disease, as well as increases normalization of the skin barrier, Bhatia said. Recent Phase 3 trials of tapinarof cream for plaque psoriasis found that 1% tapinarof cream applied once daily was superior to vehicle control in reducing plaque psoriasis over 12 weeks.6 Nevertheless, the authors suggested the need for larger and longer studies to adequately assess the efficacy and safety of tapinarof compared to currently available psoriasis treatments.
According to Bhatia, it is up to dermatologists to determine how they apply new drugs and their mechanisms of action, as well as new vehicles where intolerance or sensitivity are potential obstacles.
“The new tapinarof and roflumilast molecules will be exciting topical additions for dermatologists to reduce steroid dependency as well as safely treat long-term without the risk of atrophy or tolerance. The newly approved oral JAK inhibitors for [AD] are also going to be a game changer for us, adding a new strong option with steroids and biologics,” Bhatia said.
Bhatia is an Advisor and Consulting Researcher for AbbVie, Almirall, Arcutis Biotherapeutics, Arena, Biofrontera, Bristol Myers Squibb, Boehringer Ingelheim, Dermavant Sciences, EPI Health, Ferndale, Foamix, Galderma, Incyte, ISDIN, Johnson & Johnson, LaRoche-Posay, LEO Pharma, Eli Lilly and Company, Ortho Dermatologics, Pfizer Inc, P&G, Regeneron Pharmaceuticals, Sanofi Pharmaceuticals, Stemline, Sun Pharma and Vyne Therapeutics, and researcher for Arcutis Biotherapeutics, Biofrontera, Bristol Myers Squibb, Boehringer Ingelheim, Dermavant Sciences, Galderma, LEO Pharma, Eli Lilly and Company and Ortho Dermatologics.
- Rosen T, Bhatia N. New Drugs and Therapies in 2022. Presented at: 2022 Maui Derm for Dermatologists; January 24 to 28, 2022; Maui, Hawaii.
- PAD cream technology. PAD technology. Accessed January 21, 2022. https://padcream.com
- Lebwohl M, Kircik L, Lacour JP, et al. Topical calcipotriene/betamethasone dipropionate foam twice weekly as proactive management of plaque psoriasis increases remission time and is well tolerated over 52 weeks (PSO-LONG trial). Am Acad Dermatol.2021 May;84(5):1269-1277. doi:10.1016/j.jaad.2020.09.037. Epub 2020 Sep 18. Accessed January 20, 2022.
- Rivqoq (unadacitinib) receives US FDA approval for active psoriatic arthritis. AbbVie. Press release. Published December 14, 2021. Accessed January 20, 2022. https://news.abbvie.com/news/press-releases/rinvoq-upadacitinib-receives-us-fda-approval-for-active-psoriatic-arthritis.htm
- US FDA Approves Pfizer’s Cibinqo (Abrocitinib) For Adults With Moderate To Severe Atopic Dermatitis. Pfizer. Press release. Published January 14, 2022. Accessed January 20, 2022. https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-cibinqor-abrocitinib-adults
- Lebwohl MG, Stein Gold L, Strober B, et al. Phase 3 trials of Tapinarof cream for plaque psoriasis. N English J med. 2021 Dec 9;385(24):2219-2229. doi: 10.1056/NEJMoa2103629. Accessed January 20, 2022.