Abrocitinib significantly improves moderate-to-severe atopic dermatitis;NEJM
Written By : Dr Satabdi Saha
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2021-04-19 02:15 GMT | Update On 2021-04-19 08:08 GMT
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Abrocitinib at a dose of either 200 mg or 100 mg once daily resulted in significantly greater reductions in signs and symptoms of moderate-to-severe atopic dermatitis than placebo at weeks 12 and 16,suggests the finding from a recent study in The New England Journal of Medicine. Researchers have further opined that the 200-mg dose, but not the 100-mg dose, of abrocitinib was superior to dupilumab with respect to itch response at week 2.
The oral Janus kinase 1 (JAK1) inhibitor abrocitinib, which reduces interleukin-4 and interleukin-13 signaling, is being investigated for the treatment of atopic dermatitis. Data from trials comparing JAK1 inhibitors with monoclonal antibodies, such as dupilumab, that block interleukin-4 receptors are limited.
For the recent study design, a phase 3, double-blind trial was carried out, where randomly assigned patients with atopic dermatitis that was unresponsive to topical agents or that warranted systemic therapy (in a 2:2:2:1 ratio) received 200 mg or 100 mg of abrocitinib orally once daily, 300 mg of dupilumab subcutaneously every other week (after a loading dose of 600 mg), or placebo; all the patients received topical therapy.
The primary end points were an Investigator's Global Assessment (IGA) response (defined as a score of 0 [clear] or 1 [almost clear] on the IGA [scores range from 0 to 4], with an improvement of ≥2 points from baseline) and an Eczema Area and Severity Index–75 (EASI-75) response (defined as ≥75% improvement from baseline in the score on the EASI [scores range from 0 to 72]) at week 12. The key secondary end points were itch response (defined as an improvement of ≥4 points in the score on the Peak Pruritus Numerical Rating Scale [scores range from 0 to 10]) at week 2 and IGA and EASI-75 responses at week 16.
Data analysis revealed some interesting facts.
• A total of 838 patients underwent randomization; 226 patients were assigned to the 200-mg abrocitinib group, 238 to the 100-mg abrocitinib group, 243 to the dupilumab group, and 131 to the placebo group.
• An IGA response at week 12 was observed in 48.4% of patients in the 200-mg abrocitinib group, 36.6% in the 100-mg abrocitinib group, 36.5% in the dupilumab group, and 14.0% in the placebo group (P<0.001 for both abrocitinib doses vs. placebo); an EASI-75 response at week 12 was observed in 70.3%, 58.7%, 58.1%, and 27.1%, respectively (P<0.001 for both abrocitinib doses vs. placebo).
• The 200-mg dose, but not the 100-mg dose, of abrocitinib was superior to dupilumab with respect to itch response at week 2.
• Neither abrocitinib dose differed significantly from dupilumab with respect to most other key secondary end-point comparisons at week 16.
• Nausea occurred in 11.1% of the patients in the 200-mg abrocitinib group and 4.2% of those in the 100-mg abrocitinib group, and acne occurred in 6.6% and 2.9%, respectively.
For full article follow the link: The New England Journal of Medicine Abrocitinib Versus Placebo or Dupilumab for Atopic Dermatitis N. Engl. J. Med 2021 Mar 25;384(12)1101-1112, T Bieber, EL Simpson, JI Silverberg, D Thaçi, C Paul, AE Pink, Y Kataoka, CY Chu, M DiBonaventura, R Rojo, J Antinew, I Ionita, R Sinclair, S Forman, J Zdybski, P Biswas, B Malhotra, F Zhang, H Valdez, JADE COMPARE Investigators
Primary source:The New England Journal of Medicine
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