The JAK inhibitor deuruxolitinib showed efficacy and safety among patients with alopecia areata in phase 3 trials and was subsequently approved by the FDA. The approved dosing is 8 mg twice daily, which showed efficacy in the phase 2 dose-ranging study. This phase 2 dose-optimization study, conducted by Brett King, MD, PhD, Dermatology Physicians of Connecticut, Fairfield, Connecticut, and colleagues, compared the efficacy and safety of 8 mg deuruxolitinib twice daily with 16 mg deuruxolitinib once daily.<\/p>\n
This study enrolled 57 patients with severe alopecia areata who were randomly assigned 1:1 to receive either 8 mg deuruxolitinib twice daily (n = 29) or 16 mg deuruxolitinib once daily (n = 28) for 24 weeks. Randomization was stratified by three alopecia areata subtypes: patchy type hair loss, complete hair loss on the scalp with or without body hair loss, or limited, band-like hair loss. SALT score was assessed at screening, baseline, and for every 4 weeks until Week 24. The primary end point was relative change in SALT score from baseline.<\/p>\n
After a follow-up duration of 24 weeks, the mean relative change in SALT score from baseline was 46.4 among patients who received 8 mg deuruxolitinib twice daily compared to 18.0 with those who received 16 mg once daily. The mean relative change in SALT score from baseline over time was also higher in the 8 mg twice daily arm than the 16 mg once daily arm. The proportion of patients who achieved a SALT score of less than or equal to 20 and less than or equal to 10 over time was 34.5% and 20.7%, respectively, in the 8 mg twice daily arm compared to 10.7% and 3.6% in the 16 mg once daily arm at week 24.<\/p>\n
Of the total treatment-emergent adverse events reported, 29 events in 12 patients in the 8 mg twice daily arm and 13 in 14 patients in the 16 mg once daily arm were considered related or possibly related to deuruxolitinib. No treatment-emergent adverse events of special interest (serious infections, malignancy, major adverse cardiovascular events, or thrombosis) occurred in either arm. There was one treatment-emergent adverse event (increased blood creatinine) which led to drug interruption, with the patient continuing on the study after resolution. There were no reported serious treatment-emergent adverse events, or drug discontinuations caused by treatment-emergent adverse events, or deaths.<\/p>\n
Dr. King and colleagues concluded, \u201cAcross all endpoints, BID [twice daily] dosing of deuruxolitinib was associated with greater scalp hair regrowth compared with QD [once daily] dosing.\u201d They added that this study \u201cnot only shows that BID dosing is necessary to optimize the efficacy of deuruxolitinib, but that hair growth is dependent on all-day exposure to deuruxolitinib (ie that pharmacokinetics and pharmacodynamics are linked, which likely informs the treatment of AA in general.)\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"The JAK inhibitor deuruxolitinib showed efficacy and safety among patients with alopecia areata in phase 3 trials and…\n","protected":false},"author":2,"featured_media":620574,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[163,85,46],"class_list":["post-620573","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health","tag-health","tag-il","tag-israel"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/620573","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/comments?post=620573"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/posts\/620573\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media\/620574"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/media?parent=620573"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/categories?post=620573"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/il\/wp-json\/wp\/v2\/tags?post=620573"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}