Faculty Bibliography

BACKGROUND:Baricitinib is approved for the treatment of adults with severe alopecia areata (AA). In the absence of robust data on the patterns of regrowth during treatment of severe AA, there is a gap in the knowledge regarding treatment expectations. OBJECTIVES/OBJECTIVE:To examine whether different clinical response subgroups could be identified in baricitinib-treated patients with severe AA and factors that contribute to these subgroups. METHODS:The BRAVE-AA1 and BRAVE-AA2 phase III trials enrolled patients with severe AA [Severity of Alopecia Tool (SALT) score ≥ 50 (≥ 50% scalp hair loss)]. Patients randomized to baricitinib 4 mg or 2 mg retained their treatment allocation for 52 weeks. Based on patterns identified through growth mixture modelling (GMM), patients were categorized into responder subgroups according to when they first achieved ≥ 30% improvement from baseline in SALT score (SALT30). For each responder subgroup, trajectories of response (i.e. achievement of a SALT score ≤ 20, SALT score ≤ 10 and ≥ 50% change from baseline in SALT score) and baseline disease characteristics are reported. RESULTS:Respectively, 515 and 340 patients were randomized to once-daily baricitinib 4 mg and 2 mg at baseline; 69% and 51%, respectively, achieved SALT30 at least once by week 52. Based on GMM findings, we identified three responder subgroups: early (SALT30 by week 12), gradual (SALT30 after week 12-week 36) and late (SALT30 after week 36-week 52). The proportions of early, gradual and late responders and nonresponders were, respectively, 33%, 28%, 8% and 31% among patients treated with baricitinib 4 mg, and 20%, 23%, 9% and 49%, respectively, among those treated with baricitinib 2 mg. Early responders had a shorter trajectory to maximal clinical outcomes (e.g. > 78% achieved a SALT score ≤ 20 by week 36) vs. gradual or late responders. Early responders were more frequent among patients with baseline severe AA (SALT score 50 to < 95) vs. very severe AA (SALT score 95-100). Overall, responders (early to late) were more frequent in patients with short (< 4 years) episodes of hair loss. CONCLUSIONS:These analyses identified early, gradual and late responder subgroups for scalp hair regrowth in baricitinib-treated patients with severe AA, and that these subgroups are influenced by baseline characteristics. Findings from these analyses will help to inform treatment expectations for scalp hair regrowth.

Introduction: In pivotal BRAVE-AA1 and AA2 phase 3 clinical trials, the Janus kinase (JAK)1/JAK2 inhibitor baricitinib has demonstrated efficacy in achieving clinically meaningful regrowth of hair in patients with severe alopecia areata. While a significant proportion of patients achieve regrowth by weeks 36 and 52 on baricitinib versus placebo, other patients, particularly those with longer episode duration or with higher disease severity, require more time on therapy to see full treatment benefit. The treatment benefit and distribution of SALT scores at Week 52 across the spectrum of responders is reported here. Methods: Adults with Severity of Alopecia Tool (SALT) score ≥50 (≥50% scalp hair loss) were enrolled into BRAVE-AA1 and BRAVE-AA2. Patients were randomized 2:2:3 to receive once-daily placebo (N=345), baricitinib 2 mg (BARI-2MG) (N=340), or baricitinib 4 mg (BARI-4MG) (N=515). Patients randomized to baricitinib retained their treatment allocation through Week 52. Pooled outcomes were assessed by baricitinib group and in patients with SALT score ≤20 versus SALT score >20 at Week 52. Median and interquartile range (IQR) of SALT scores was assessed with last observation carried forward. Results: At baseline, the median SALT score across 1200 randomized patients was 96 (near-total hair loss), with 638 (53.2%) having SALT score 95-100. At Week 52, 24.1% of patients who received BARI-2MG and 41.6% of patients who received BARI-4MG had SALT score ≤20; median (IQR) absolute SALT scores in this group were 7 (1-12) with BARI-2MG treatment and 3 (0-11) with BARI-4MG treatment. 17.9% of patients who received BARI-2MG and 18.8% of patients who received BARI-4MG patients achieved SALT scores of 21-49 at Week 52; median (IQR) scores were 34 (27-41) following BARI-2MG treatment and 31 (26-42) following BARI-4MG treatment. Conclusions: While a significant proportion of patients achieved SALT ≤20, the findings of this analysis indicate that partial benefit across scalp hair regrowth is achieved even if patients do not meet clinical response criteria of SALT ≤20. There is a substantial proportion of patients who demonstrate movement towards improvement across the SALT score spectrum. In these patients, a longer treatment course may be necessary to achieve optimal treatment outcomes.

WHAT IS THIS SUMMARY ABOUT?/UNASSIGNED:. ALLEGRO-2b/3 looked at how well and safely the study medicine, ritlecitinib, works in treating people with alopecia areata ('AA' for short). The immune system protects your body from outside invaders such as bacteria and viruses. AA is an autoimmune disease, meaning a disease in which one's immune system attacks healthy cells of the body by mistake. In AA, the immune system attacks hair follicles, causing hair to fall out. AA causes hair loss ranging from small bald patches to complete hair loss on the scalp, face, and/or body. Ritlecitinib is a medicine taken as a pill every day, by mouth, that is approved for the treatment of severe AA. It blocks processes that are known to play a role in causing hair loss in patients with AA. WHAT WERE THE RESULTS OF THE STUDY?/UNASSIGNED:Adults and adolescents (12 years and older) took part in the ALLEGRO-2b/3 study. They either took ritlecitinib for 48 weeks or took a placebo (a pill with no medicine) for 24 weeks. Participants taking placebo later switched to taking ritlecitinib for 24 weeks. The study showed that participants taking ritlecitinib had more hair regrowth on their scalp after 24 weeks than those taking the placebo. Hair regrowth was also seen on the eyebrows and eyelashes in participants taking ritlecitinib. Hair regrowth continued to improve to week 48 with continued ritlecitinib treatment. In addition, more participants taking ritlecitinib reported that their AA had 'moderately' or 'greatly' improved after 24 weeks than those taking the placebo. Similar numbers of participants taking ritlecitinib or placebo had side effects after 24 weeks. Most side effects were mild or moderate. WHAT DO THE RESULTS OF THE STUDY MEAN?/UNASSIGNED:NCT03732807 (phase 2b/3 ALLEGRO study).

BACKGROUND:Mesotherapy, a technique of transdermal microinjections of specific preparations, is increasingly used in fields such as dermatology and specifically for alopecia treatment. Its popularity stems from its ability to deliver drugs in a targeted manner while minimizing systemic side effects. OBJECTIVE:To assess and review current knowledge regarding the use of mesotherapy to deliver alopecia medications and highlight future directions for research. MATERIALS AND METHODS/METHODS:The authors used research databases including PubMed and Google Scholar to identify current literature on mesotherapy and alopecia. The following search terms were used among other terms: "Mesotherapy" or "Intradermal" AND "Alopecia". RESULTS:Recent studies are promising for the intradermal delivery of dutasteride and minoxidil in the treatment of androgenetic alopecia. CONCLUSION/CONCLUSIONS:Although limitations exist with dutasteride and minoxidil therapies, further research regarding the preparation, delivery, and maintenance of these drugs is warranted as mesotherapy could establish this technique as a safe, effective, and viable treatment option for androgenetic alopecia.

Alopecia, the loss of hair on the scalp and/or body, experienced by millions of people worldwide, can be a very debilitating condition. Specifically, androgenetic alopecia (AGA), commonly known as male or female pattern baldness, is the most common form of hair loss. In the African diaspora, oils have traditionally been used to promote hair growth and recently, the application of hair oils to the scalp for the treatment of alopecia has become increasingly popular. With the recent surge of hair oil usage in the Black community, more research is needed to determine the efficacy of hair oils, as most studies have primarily used mice subjects. This article reviews the existing literature to better understand the use of hair oils in the treatment of androgenetic alopecia. Specifically, we investigate the popular carrier oils, castor oil, and pumpkin oil as well as the essential oils, lavender, peppermint, rosemary, and tea tree oil.