Advances in Dermatology: A Year in Review
By Cather McKay, MD
2020 brought the most significant public health crisis many of us will experience in our lifetime. The novel coronavirus took our country and the world by storm, changing every aspect of our lives.
Even in the chaos, health care professionals across the world have united to share experiences and learn about the
novel coronavirus together in real time. In a matter of months, scientists developed two mRNA vaccines showing up to 95% efficacy with plans for distribution in the near future.
If your time and mental energy was understandably occupied this year, see below for some of the biggest news affecting our specialty to help keep you up to speed.
COVID-19 AND DERMATOLOGY
As dermatologists, we’ve been tasked with helping our patients and the public understand “COVID toes,” hand dermatitis, “maskne,” and telogen effluvium. Data collection regarding skin findings in COVID-19 continues in the form of a registry organized by the American Academy of Dermatology.
Notably, a spike in pernio/chilblains-like acral lesions led to debate over its relationship to the virus. Laboratory and histologic characteristics in a series of 40 patients suggest a possible relationship with a strong interferon-alpha response to the virus1.
At the outset of the pandemic, there was much concern for our patients on immunosuppressive and biologic therapies. Data suggests that outcomes in patients on biologics with COVID-19 are similar to the general population, while those on non-biologic systemic therapies may have higher rates of hospitalization2,3.
ACNE AND ROSACEA
Clascoterone 1% cream (Winlevi®), a topical androgen receptor inhibitor, was approved in August for acne vulgaris in men and women 12 years and older and is expected to become available early next year4. Its use in androgenetic alopecia5 and even hidradenitis suppurativa is under investigation.
Topical minocycline 1.5% foam (Zilxi®) received FDA-approval for adults with inflammatory rosacea, in addition to the 4% foam (Amzeeq®) approved for acne last year.
PSORIASIS
In July, guselkumab (Tremfya®) became the first IL-23 inhibitor approved for psoriatic arthritis in addition to psoriasis. Another IL-23 inhibitor, mirikizumab, and IL-17A and F inhibitor bimekizumab, continue to succeed in phase 3 trials for psoriasis6,7.
Ustekinumab (Stelara®) and ixekizumab (Taltz®) both received expanded indications for children as young as age 6 years with moderate to severe plaque psoriasis.
Topical options are also receiving attention. Roflumilast cream, a phosphodiesterase-4 inhibitor, is in trials for plaque psoriasis8, as well as seborrheic dermatitis and atopic dermatitis. Tapinarof, a therapeutic aryl hydrocarbon receptor modulating agent (TAMA), is under investigation for treatment of psoriasis and atopic dermatitis9.
ATOPIC DERMATITIS & PRURITUS
JAK inhibitors are inching closer to approval for atopic dermatitis. Abrocitinib, baracitinib (Olumiant®), and upadacitinib (Rinvoq®), continue to do well in clinical trials10,11,12. The pan JAK inhibitor delgocitinib ointment received fast track designation for chronic hand eczema in adults based on success in phase 3 trials13.
Inhibition of IL-13 with tralokinumab and IL-31 receptor A with nemolizumab is proving effective for atopic dermatitis14,15. Nemolizumab was also shown to be effective in decreasing pruritus and skin lesions in patients with prurigo nodularis in a phase 2 trial16.
The expanded indication of dupilumab (Dupixent®) for children six years and up with moderate to severe atopic dermatitis was enthusiastically welcomed in May of this year. Dupilumab was also shown to be effective for adults with bullous pemphigoid in a multicenter case series of 13 patients17.
Children as young as three months old with mild to moderate atopic dermatitis gained a topical option with the expanded indication for crisaborole 2% ointment (Eucrisa®) in this age group.
A study by Paller, et al, quelled any safety concerns about cancer risk in topical tacrolimus for atopic dermatitis. There was no increase in cancer incidence in close to 8,000 children who used this medication for ≥ 6 weeks during a 10-year period18.
Finally, a phase 3 trial showed that difelikefalin, an agonist of peripheral kappa opioid receptors, decreased pruritus and improved quality of life in hemodialysis patients with uremic pruritus19.
INFECTIOUS DISEASE
The CDC’s Advisory Committee on Immunization Practices released updated HPV vaccine recommendations earlier this year20. In short, Gardasil-9 is recommended for boys and girls at age 11 or 12, with catch-up vaccination through age 26. Patients aged 27-45 who are unvaccinated should be offered the vaccine if considered at high risk for new infection or if the vaccine would be otherwise beneficial.
Abametapir (Xeglyze®) is a newly approved one-time topical treatment for head lice in children as young as six months old. Previously prescription-only ivermectin 0.5% lotion (Sklice®) is now available over-the-counter for head lice in children six months and older.
CUTANEOUS ONCOLOGY
Melanoma therapy continues to advance with investigations into sequential and combination treatment with targeted and immunotherapies. Melanoma mortality has been decreasing by about 5% a year since 2014 in US whites21, the demographic with the highest incidence of melanoma. Further evaluation of other demographics is needed.
An oral mitogen-activated protein kinase (MEK) inhibitor, selumetinib (Koselugo®), became the first drug approved to treat any form of Neurofibromatosis type 1. Selumetinib is indicated for patients two years and older with symptomatic, inoperable plexiform neurofibromas.
PD-1 inhibitor pembrolizumab (Keytruda®) was approved for recurrent or metastatic cutaneous squamous cell carcinoma not amenable to surgery or radiation.
COSMETIC DERMATOLGY
Revance and Teoxane SA introduced three new “resilient hyaluronic acid” (RHA) fillers to the US market this year. Revance continues trials for daxibotulinumtoxinA with expected FDA-approval in the future.
Galderma also successfully launched Restylane® Kysse for lip augmentation and correction of upper perioral rhytides. Juvederm®’s Voluma™ XC received an expanded indication to include chin augmentation, in addition to its use in the cheeks.
Collagenase clostridium histolyticum (Qwo™) was approved by the FDA as an injectable treatment for cellulite in the buttocks of adult women22 and is expected to become available in the Spring of 2021.
As 2020 comes to a close, we are left with much to reflect upon. With profound gratitude, we recognize our colleagues in the medical community fighting to control the COVID-19 pandemic, as well as those who work to advance the field dermatology. And with heavy hearts, we recognize the lives lost this year. May the New Year bring health and happiness. Happy Holidays and Happy New Year.
REFERENCES
1. Hubiche T, Cardot-Leccia N, Le Duff F, et al. Clinical, Laboratory, and Interferon-Alpha Response Characteristics of Patients With Chilblain-like Lesions During the COVID-19 Pandemic. JAMA Dermatol. 2020 Nov 25:e204324.
2. Haberman R, Axelrad J, Chen A, et al. Covid-19 in Immune-Mediated Inflammatory Diseases - Case Series from New York. N Engl J Med. 2020 Jul 2;383(1):85-88.
3. Mahil SK, Dand N, Mason KJ, et al. Factors associated with adverse COVID-19 outcomes in patients with psoriasis-insights from a global registry-based study. J Allergy Clin Immunol. 2020 Oct 16:S0091-6749(20)31413-5.
4. Hebert A, Thiboutot D, Stein Gold L, et al. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020 Jun 1;156(6):621-630.
5. Sun HY, Sebaratnam DF. Clascoterone as a novel treatment for androgenetic alopecia. Clin Exp Dermatol. 2020 May 18.
6. Lilly. (2020, July 17). Lilly's Mirikizumab Superior to Cosentyx® (secukinumab) in a Phase 3 Study for Patients with Moderate to Severe Plaque Psoriasis [Press release].
7. Reich K, Papp KA, Blauvelt A, et al. “Efficacy and safety of bimekizumab in patients with moderate-to-severe plaque psoriasis: results from BE VIVID: a 52-week phase 3, randomized, double-blinded, ustekinumab- and placebo-controlled study,” American Academy of Dermatology VMX. June 13, 2020.
8. Lebwohl MG, Papp KA, Stein Gold L, et al. Trial of Roflumilast Cream for Chronic Plaque Psoriasis. N Engl J Med. 2020 Jul 16;383(3):229-239.
9. Paller AS, Gold LS, Soung J, et al. Efficacy and Patient-Reported Outcomes from a Phase IIb, Randomized Clinical Trial of Tapinarof Cream for the Treatment of Adolescents and Adults with Atopic Dermatitis. J Am Acad Dermatol. 2020 Jun 2:S0190-9622(20)31011-2.
10. Silverberg JI, et al. Efficacy of abrocitinib monotherapy by body location in patients with moderate-to-severe atopic dermatitis: Pooled results from phase 2b/3 studies. Presented at: European Academy of Dermatology and Venereology congress; Oct 29-31, 2020 (virtual meeting).
11. Simpson EL, Lacour JP, Spelman L, et al. Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials. Br J Dermatol. 2020 Aug;183(2):242-255.
12. Guttman E. Safety and efficacy of upadacitinib monotherapy in adolescents and adults with moderate-to-severe atopic dermatitis: Results from 2 pivotal, phase 3, randomized, double-blinded, placebo-controlled studies (Measure Up 1 and Measure Up 2). Presented at: European Academy of Dermatology and Venereology Congress; Oct 29-31, 2020 (virtual meeting).
13. Nakagawa H, Nemoto O, Igarashi A, et al. Delgocitinib ointment, a topical Janus kinase inhibitor, in adult patients with moderate to severe atopic dermatitis: A phase 3, randomized, double-blind, vehicle-controlled study and an open-label, long-term extension study. J Am Acad Dermatol. 2020 Apr;82(4):823-831.
14. Simpson E. Efficacy and safety of tralokinumab monotherapy in adult patients with moderate-to-severe atopic dermatitis: Results from two 52-week Phase 3 trials (ECZTRA 1 and ECZTRA 2). Presented at AAAD VMX; June 12-14, 2020; Virtual meeting.
15. Kabashima K, Matsumura T, Komazaki H, Kawashima M; Nemolizumab-JP01 Study Group. Trial of Nemolizumab and Topical Agents for Atopic Dermatitis with Pruritus. N Engl J Med. 2020 Jul 9;383(2):141-150.
16. Ständer S, Yosipovitch G, Legat FJ, et al. Trial of Nemolizumab in Moderate-to-Severe Prurigo Nodularis. N Engl J Med. 2020 Feb 20;382(8):706-716.
17. Abdat R, Waldman RA, de Bedout V, et al. Dupilumab as a novel therapy for bullous pemphigoid: A multicenter case series. J Am Acad Dermatol. 2020 Jul;83(1):46-52.
18. Paller AS, Fölster-Holst R, Chen SC, et al. No evidence of increased cancer incidence in children using topical tacrolimus for atopic dermatitis. J Am Acad Dermatol. 2020 Aug;83(2):375-381.
19. Fishbane S, Jamal A, Munera C, Wen W, Menzaghi F; KALM-1 Trial Investigators. A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus. N Engl J Med. 2020 Jan 16;382(3):222-232.
20. Oshman LD, Davis AM. Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices (ACIP). JAMA. 2020 Feb 4;323(5):468-469.
21. Berk-Krauss J, Stein JA, Weber J, et al. New systematic therapies and trends in cutaneous melanoma deaths among US Whites, 1986–2016. Am J Public Health. 2020;110(5):731-733.
22. Sadick NS, Goldman MP, Liu G, et al. Collagenase Clostridium Histolyticum for the Treatment of Edematous Fibrosclerotic Panniculopathy (Cellulite): A Randomized Trial. Dermatol Surg. 2019 Aug;45(8):1047-1056.
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