Important FDA Approvals in 2023 Lead to New, Exciting Treatments in 2024
Maui Derm's opening presentation featuring Practical Dermatology® Chief Medical Editor Neal Bhatia, MD, and Ted Rosen, MD highlighted how an expanding library of therapies gives dermatologists new tools and options for better outcomes.
A slew of big approvals for new therapies in 2023 has increased the armamentarium for dermatologists treating many conditions going into 2024, according to an opening presentation at Maui Derm 2024.
In what has become a popular annual tradition at Maui Derm, Practical Dermatology® Chief Medical Editor Neal Bhatia, MD, a dermatologist practicing in San Diego, and Ted Rosen, MD, a professor of dermatology at Baylor College of Medicine in Houston, donned their best newscaster costumes and delivered a sweeping update on new FDA-approved therapies for a variety of conditions. Highlighting what Dr. Rosen called an “incredible year for FDA approvals,” the presenters showcased many newly available and emerging therapies for conditions such as acne, seborrhea, molluscum, hidradenitis suppurativa (HS), and more.
Acne
Prominent among the new approvals was that of the triple combination therapy CABTREO, approved in October 2023. Particularly interesting, according to Dr. Rosen, were the results of a phase 2 study in which the triple combination therapy of clindamycin phosphate 1.2%, adapalene 0.15%, and benzoyl peroxide 3.1% outperformed all dual therapies for the study measure of clear/almost clear. The phase 3 study indicated that the triple combination therapy performed better than vehicle for the percent reduction in inflammatory and non-inflammatory lesions.
“In fact, every way you look at it, the triple combination therapy did better,” Dr. Rosen said.
Seborrhea
For the treatment of seborrhea, the presenters highlighted the newly approved ZORYVE FOAM (roflumilast 0.3%). The pivotal study, evaluating roflumilast 0.3% once daily for 8 weeks (applied to the primary sites of the scalp, face, and ears), showed an achievement of treatment success in 80% of patients (vs. 59% for vehicle).
“Many patients actually achieved complete clearance with both erythema and scaling, which was nice,” Dr. Bhatia said. “The best part about the foam is they like the effect, putting it on surface areas that are difficult to treat, especially with a foam. So we have some good options here.”
Molluscum Contagiosum
The highlighted therapy for molluscum was cantharidin 0.7% (YCANTH), approved in July 2023 in adults and children 2 years of age and older. It can be applied accurately by a health care professional in the office once every three weeks at one drop per lesion with a specially designed precision applicator.
“There is erythema (45%) and vesiculation (95.5%), which is supposed to happen,” added Dr. Rosen. “It is mild to moderate.”
The other therapy for molluscum the presenters highlighted was berdazimer 10.3%, a newly approved, first-in-class, topical, controlled-nitric-oxide-release medication. When evaluated in the B-SIMPLE4 trial, the primary endpoint of complete clearance of all lesions at 12 weeks was 32.4%. The secondary endpoint of the proportion of patients achieving a lesion count of 0 or 1 was 43.5%, and the proportion of those achieving 90% or greater clearance at week 12 was 43.0% (all P<0.0001).
Hidradenitis Suppurativa
The interleukin-17 (IL-17) inhibitor secukinumab (Cosentyx), approved in October 2023, was effective for treating HS in a population of more than 1,000 adults with moderate-to-severe HS in two phase 3 placebo-controlled trials (the SUNSHINE and SUNRISE studies). Patients with five or more abscesses, less than 20 fistulae, and with disease present at one year were treated with 300 mg weekly for 5 weeks and then every four weeks (with increased frequency to every two weeks if necessary). They were then assessed at 16 and 52 weeks. The results showed the therapy was superior to placebo.
“We really don’t want to see these patients back,” Dr. Bhatia said. “The good news is that we can keep these patients off antibiotics and keep them in better situations for themselves with even more improvements in their overall outcomes, especially in those difficult-to-treat areas.”
Dr. Rosen added: “The decrease in the nodules and abscesses, and the decrease in the number of flares is what we want for patients, because these are the things that interrupt their lives. We still don’t have the perfect drug, but there are more coming.”
Another HS drug in development, MC2-32 (RGRN-305), targets multiple pathways involved in HS, including the inhibition of HSP-90, which leads to the inhibition of multiple inflammatory pathways related to HS (in addition to the IL-17 inhibition). The oral therapy is currently being evaluated in a randomized, double-blind, placebo-controlled study (n=15). The primary endpoint of HiSCR50 was met at week 16 by six out of 10 patients in the MC2-32 group vs. one out of five patients in the placebo group. The HiSCR 75 and HiSCR 90 scores were met by five and three out of 10 patients in the MC2-32 group, respectively, when compared to zero in the placebo group.
“This is where you can get a pill option for those patients who are struggling with antibiotics, and now we can actually get somewhere with those who don’t want to take shots,” Dr. Bhatia noted.
Psoriasis
The big approval in psoriasis in 2023 was bimekizumab (Bimzelx) for the treatment of adults with moderate-to-severe psoriasis. The therapy works by a dual IL-17A and IL-17C inhibition pathway. The pivotal study, which saw patients given a loading dose of 320 mg, and then 160 mg at weeks 0,4,8,12 and 16 weeks, every 8 weeks after that (in normal-sized patients). For larger patients (120 kg or more), a 320 mg dose every 4 weeks should be considered. The risks of oral candidiasis (between 9% and 18%) were considered low and the instances were not severe and easily treatable. Efficacy of the drug at week 16, with a PASI of 90, was between 85% to 91%. Between 59% and 68% had a PASI 100 response (indicating clearence). Out to 56 weeks, 87% to 90% of patients maintained a PASI 90 if they continued with the therapy.
“We’ve talked about bimekizumab for so many years, and it’s finally here,” Dr. Rosen said. "The bottom line is that, if you continue on the drug, you continue to improve.”
“I don’t think we’ve seen a drug where patients get better with the loading dose, which was very exciting,” Dr. Bhatia added.
Alopecia Areata
Ritlecitinib (LUTFULO), approved in June 2023 for the treatment of alopecia areata in adults and adolescents aged 12 and older, works by inhibiting JAK-3 and TEC kinase with its 50 mg dose. The 24-week pivotal study included 718 patients with a SALT score of 50 or more.
“We saw significant improvement versus placebo,” Dr. Bhatia said. “There was a 23% improvement in SALT scores of 20 or less (80% scalp coverage), 13.4% in those of 10 or less (90% scalp coverage), and a number of patients who achieved those numbers really improved well over time. The biggest thing you need to remember is to keep these patients on it for over a year. The slow start is not a reflection on the good finish with these drugs.”
The presenters also highlighted an upcoming drug, the JAK-1 and JAK-2 inhibitor deuruxolitinib, for the treatment of moderate-to-severe alopecia areata. The drug was evaluated in the phase 3 THRIVE AA2 trial, which included 517 adults with 50% or more scalp hair loss. According to its results, 33.0% of patients taking the 8 mg dose and 38.3% of those taking the 12 mg dose saw improvement in SALT scores compared with placebo-treated patients at 24 weeks.
“The nice thing is that we have ritlecitinib, and we are going to have deuruxolitinib, and we can do better with a larger library of drugs, just like with psoriasis,” Dr. Rosen said. -by Eric Raible
Source: Bhatia N, Rosen T. Dermatology In Review. Presented at: Maui Derm, January 22-26, 2024.
Disclosures
Dr. Bhatia reports affiliations with Abbvie, Advanced Derm Solutions, Almirall, Arcutis, Beiersdorf, Biofrontera, BMS, BI, Cara, Dermavant, Ferndale, Galderma, InCyte, J&J, LaRoche-Posay, Leo, Lilly, MC2, Mindera, Novartis, Ortho, Pfizer, Regeneron, Sanofi, SunPharma, Verrica, and Zerigo.
Dr. Rosen reports no relevant disclosures.