According to phase 3 data, upadacitinib may represent a potential treatment option for patients with severe alopecia areata.<\/p>\n
There is currently an unmet need for systemic therapies for alopecia areata\u2014with only three agents approved (Janus kinase [JAK] inhibitors baricitinib, ritlecitinib, and deuruxolitinib). Many patients are not able to achieve a Severity of Alopecia Tool (SALT) score of 20 or lower in clinical trials of those treatments. Upadacitinib is an oral, selective JAK inihibitor, targeting JAK1 more potently than JAK2, JAK3, and tyrosine kinase 2; and it is approved for the treatment of several inflammatory conditions including atopic dermatitis. Arash Mostaghimi, MD, MPA, MPH, of Brigham and Women\u2019s Hospital, Boston, Massachusetts, and colleagues report on two parallel phase 3 replicate randomized clinical trials designed to determine the efficacy and safety of upadacitinib for patients with severe alopecia areata.<\/p>\n
UP-AA1 and UP-AA2 were two parallel phase 3 replicate clinical trials that included 1,399 patients (1,281 adults and 118 adolescents) with severe alopecia areata, defined as a SALT score of 50 or higher. Both trials included a placebo-controlled, double-blinded treatment period of 24 weeks followed by a blinded extension period of 28 weeks. The mean SALT score for all patients at baseline was 83.9, with a standard deviation of 18.9. Patients were randomly assigned on a 2:2:1 basis to receive 15 mg of upadacitinib once daily (UP-AA1, n=270; UP-AA2, n=289), 30 mg of upadacitinib once daily (UP-AA1, n=271; UP-AA2, n=289), or matching placebo (UP-AA1, n=135; UP-AA2, n=145). The primary end point was a SALT score of 20 or lower at week 24. Secondary end points included improvements in clinician-reported outcomes for eyebrows and eyelashes; SALT score of 20 or lower at weeks 4, 8, and 12; SALT score of 10 or lower; and SALT score of 0 at week 24.<\/p>\n
In both trials, both the 15-mg and 30-mg doses of upadacitinib were \u201csuperior to placebo in achieving the primary end point of SALT score 20 or less at week 24,\u201d as Dr. Mostaghimi and colleagues wrote. Of patients receiving upadacitinib (UP-AA1 and UP-AA2, respectively), 45.2% and 44.6% of those in the 15-mg group and 55.0% and 54.3% in the 30-mg group achieved SALT scores of 20 or lower at week 24, compared with 1.5% and 3.4% in the placebo groups (P<0.001 in all comparisons with placebo). The primary end point was met for both doses of upadacitinib, beginning at week 8. In addition, in UP-AA1, 14.1% and 20.3% of patients in the 15-mg and 30-mg upadacitinib arms, respectively, achieved a SALT score of 0 at week 24, compared with 0% in the placebo arm. In UP-AA2, 13.1% and 22.5% of patients in the 15-mg and 30-mg upadacitinib arms, respectively, achieved a SALT score of 0 at week 24, compared with 0.7% in the placebo arm. The authors noted that \u201cboth doses of upadacitinib also showed superiority to placebo in most multiplicity-controlled secondary end points.\u201d<\/p>\n
The safety profile was similar to and consistent with approved indications for both doses and among both adult and adolescent patients. The most common treatment-emergent adverse events (reported in 5% or more of patients) in any arm were upper respiratory tract infection, acne, elevated blood creatine phosphokinase, and nasopharyngitis. Serious treatment-emergent adverse events occurred in 9 patients (1.6%) receiving 15 mg of upadacitinib, 13 patients (2.3%) receiving 30 mg of upadacitinib, and 1 patient (0.4%) receiving placebo.<\/p>\n
Because alopecia areata is often associated with a psychosocial and emotional burden, it is important to note that in addition to meeting the key efficacy outcome, there was also a significant improvement in \u201cpatient impression of change as well as multiple facets of health-related quality of life\u201d with upadacitinib in these trials. Dr. Mostaghimi and colleagues concluded, \u201cThese findings suggest that upadacitinib may be an effective therapeutic option for adults and adolescents with severe AA [alopecia areata].\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"According to phase 3 data, upadacitinib may represent a potential treatment option for patients with severe alopecia areata.…\n","protected":false},"author":2,"featured_media":605480,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[103,61,60],"class_list":["post-605479","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health","tag-health","tag-ie","tag-ireland"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/605479","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/comments?post=605479"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/605479\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/605480"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=605479"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=605479"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=605479"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}