Dermatomyositis is 1 of the 3 main types of idiopathic inflammatory myopathies. Most patients present with typical skin signs and half of them also suffer from muscle weakness [1,2]. There is a demand for more efficacious treatment options because even with extensive use of current therapies, a great proportion of patients is not adequately controlled [3].
A phase 2a open-label trial (NCT03529955) investigated the phosphodiesterase-4 inhibitor apremilast as an add-on therapy for recalcitrant cutaneous dermatomyositis [4]. The study included 8 patients who met the inclusion criteria of Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) ≥5 while on treatment with a stable dose for 1 month, age 18–75 years, and appropriate cancer screening. “All patients were heavily pre-treated,” Prof. Carole Bitar (Tulane University School of Medicine, LA, USA) pointed out. For 6 months, the study participants received twice-daily 30 mg of apremilast on top of their regular therapy with steroids and/or steroid-sparing drugs. Participants were monitored for 7 months on parameters such as CDASI and dermatology life quality index (DLQI), and skin biopsies were obtained at baseline and at 3 months for further genetical and immunohistochemical investigation.
After 12 weeks of treatment, the participants showed a general response rate of 87.5%. Prof. Bitar explained that a continuous decrease in CDASI score was observed over time of treatment. The results established a significant 12.9-point mean drop in CDASI (P<0.05). “There was also relevant improvement in DLQI,” Prof. Bitar said.
Only grade 1–2 side effects according to the Common Terminology Criteria for Adverse Events (version 5.0) were reported. The most common were headache (87.5%), nausea (62.5%), and diarrhoea (50%).
The researchers also wanted to find out why apremilast influences dermatomyositis. To gain further insight, the researchers looked at the results of RNA sequencing, specifically of ≥2-fold transcriptome changes (P<0.01). They identified 195 affected genes, of which 123 were downregulated and 72 upregulated through apremilast. A gene set enrichment analysis detected 13 pathways that were downregulated by the apremilast treatment. Of note, these included IL-6, IL-12, IL-23, as well as STAT-11 and STAT-3. Inhibition of JAK/STAT signalling was corroborated by the immunohistochemical assessment.
In summary, the add-on treatment of recalcitrant dermatomyositis with apremilast showed promising benefits and was well tolerated.
- Bitar C, et al. JAAD Case Rep. 2019;5(2):191–194.
- Piguet V, Choy E. Br J Dermatol. 2018;179(6):1233–1234.
- Wolstencroft PW, et al. JAMA Dermatol. 2018;154(1):44–51.
- Bitar C, et al. Apremilast induces high response rates in recalcitrant dermatomyositis with downregulation of multiple inflammatory pathways: results of a phase 2a open-label study. S026, AAD 2022 Annual Meeting, 25–29 March, Boston, MA, USA.
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Table of Contents: AAD 2022
Featured articles
Letter from the Editor
Lebrikizumab treatment leads to encouraging outcomes in multiple traits of AD
New Developments and Unmet Needs in Dermatology
Light at the end of the tunnel for vitiligo therapy
Intestinal microbe-preparation: Modest activity but safe for mild psoriasis
Alopecia areata: 1-year baricitinib treatment increases success
New anticholinergic preparation is effective and tolerable in hyperhidrosis
What’s Hot in Rare Diseases
Add-on apremilast may improve recalcitrant dermatomyositis
Could dupilumab put an end to the therapeutic draught in prurigo nodularis?
Fungal skin infections in children: A diagnosis to keep in mind
Innovative gel speeds up clearance of molluscum contagiosum lesions
JAK inhibition offers promising treatment prospects for uncommon dermatoses
JAK inhibitors may offer a new horizon in the treatment of sarcoidosis
Psoriasis: State of the Art
New insights into psoriasis comorbidity
Long-term psoriasis treatment with bimekizumab results in maintained efficacy
Novel developments in topical psoriasis therapy
Atopic Dermatitis: Novel Agents Enter the Stage
JAK inhibitors in AD: Setting the efficacy bar even higher
Lebrikizumab treatment leads to encouraging outcomes in multiple traits of AD
Novel IL-4/IL-13 blocker shows high efficacy with only modest conjunctivitis signal
Posters
Inpatient dermatologic therapy is linked to lower mortality and readmission rates
AD treatment during the pandemic: dupilumab does not raise COVID-19 infection risk
Upadacitinib: Fast and more pronounced skin improvement in AD patients
Dermatology diseases need the highest doses of biologics
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