Clinical Benefits of Baricitinib Therapy According to Scalp Hair Regrowth in Patients with Severe Alopecia Areata.

OBJECTIVES: The present analyses report integrated results from BRAVE-AA1 (NCT03570749) and BRAVE-AA2 (NCT03899259) on the clinical benefits of baricitinib treatment on the basis of the amount of scalp hair regrowth through 52 weeks of treatment. METHODS: This post hoc analysis was conducted with data from patients who were treated continuously for 52 weeks with baricitinib 4 mg or 2 mg. Clinical outcomes were assessed using the Severity of Alopecia Tool (SALT) and Clinician-Reported Outcome (ClinRO) for Eyebrow (EB) and Eyelash (EL) hair. Secondary measures included the Hospital Anxiety and Depression Scale and Skindex-16 adapted for alopecia areata. At week 52, patients were classified into three subgroups: SALT ≤ 20 response, intermediate response (achieved a 30% improvement from baseline (SALT30) without a SALT score ≤ 20), or nonresponse (never achieved SALT30). The criterion of SALT30 approximates a minimal clinical meaningful response to therapy. RESULTS: At week 52, with baricitinib 4 mg treatment, the greatest (70%) improvement in EB and EL was observed in responders, but approximately 50% of patients with intermediate response and 20% of nonresponders experienced complete/nearly complete EB and EL regrowth. Improvement in emotional distress was directionally related to improvements in scalp hair regrowth, while impact on quality of life was proportionately greater for the responder subgroup. CONCLUSIONS: Clinically meaningful regrowth in eyebrow and eyelash hair can occur in the absence of complete scalp hair regrowth after treatment with baricitinib. Emotional distress and quality of life improvement is most associated with obtaining a clinical meaningful improvement in scalp hair. TRIAL REGISTRATION NUMBER: BRAVE-AA1, ClinicalTrials.gov number, NCT03570749, start date, 24 September 2018; BRAVE-AA2, ClinicalTrials.gov number, NCT03899259, start date, 8 July 2019.

Treatment modalities for lymphocytic and neutrophilic scarring alopecia.

Primary cicatricial alopecia can result in permanent hair loss from the destruction of hair follicles. Early intervention is key in controlling disease progression, reducing symptoms, and optimizing hair density. Treatment modalities range from topical and intralesional therapies to oral medications and light therapy.

Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata over 52 Weeks of Continuous Therapy in Two Phase III Trials (BRAVE-AA1 and BRAVE-AA2).

BACKGROUND: The oral Janus kinase (JAK) inhibitor baricitinib has demonstrated efficacy for severe alopecia areata (AA) over 36 weeks. There are limited data on the longer-term treatment of AA. OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of baricitinib for AA in adults with ≥50% scalp hair loss through 52 weeks of continuous therapy in two phase III trials (BRAVE-AA1 and BRAVE-AA2). METHODS: Patients randomized to baricitinib at baseline in BRAVE-AA1 (N = 465) and BRAVE-AA2 (N = 390) retained their treatment allocation through Week 52. Efficacy outcomes included the proportion of patients achieving a Severity of Alopecia Tool (SALT) score ≤ 20 (≤ 20% scalp hair loss). Data were censored after permanent treatment discontinuation or if collected remotely due to the coronavirus disease 2019 (COVID-19) pandemic. RESULTS: Response rates for hair regrowth increased over the 52-week period. Of patients treated with baricitinib 4 mg and 2 mg, respectively, 40.9% and 21.2% in BRAVE-AA1 and 36.8% and 24.4% in BRAVE-AA2 achieved a SALT score ≤ 20 at Week 52. The most frequent treatment-emergent adverse events included upper respiratory tract infection, headache, nasopharyngitis, acne, urinary tract infection, creatine phosphokinase elevation, and COVID-19 infection. LIMITATION: There were no comparisons with placebo. CONCLUSION: Efficacy of baricitinib for adults with severe AA continuously improved over 52 weeks, indicating that long-term treatment may be necessary to observe maximum clinical benefit. There were no new safety signals. CLINICALTRIALS REGISTRATION: ClinicalTrials.gov NCT03570749 and NCT03899259. Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata: Week-52 Results from BRAVE-AA1 and BRAVE-AA2.

Alopecia areata (AA) is an autoimmune disease that causes patchy hair loss on the scalp, face, and body. Baricitinib is a Janus kinase inhibitor that is approved to treat AA in several countries, based on results from two studies, BRAVE-AA1 and BRAVE-AA2. In these studies, adults with at least 50% scalp hair loss were treated with baricitinib for 36 weeks. Long-term therapy is important in AA, and hair regrowth can take longer in some patients with severe disease. Therefore, we assessed outcomes from a longer course of therapy. In this study, we report the results after 52 weeks of continuous treatment with baricitinib 4 mg or 2 mg in 465 patients in BRAVE-AA1 and 390 patients BRAVE-AA2. The goal was to reduce scalp hair loss to 20% or less by Week 52. In BRAVE-AA1, 40.9% of patients who took baricitinib 4 mg and 21.2% of patients who took baricitinib 2 mg had 20% or less missing scalp hair by Week 52. Similarly, in BRAVE-AA2, 36.8% of patients who took baricitinib 4 mg and 24.4% of patients who took baricitinib 2 mg had 20% or less missing scalp hair by Week 52. The most common adverse effects that were reported during the study period were upper respiratory tract infection, headache, nasopharyngitis, acne, urinary tract infection, creatine phosphokinase elevation, and coronavirus disease 2019 (COVID-19) infection. The results of longer-term treatment indicate that hair regrowth continues to improve without any new safety concerns for adults with severe AA taking baricitinib.

Physician values in alopecia areata treatment decision-making: A qualitative assessment.

Background: Alopecia areata (AA) is a disease of hair loss with multiple treatment options. Physicians play an important role in guiding patients during the decision-making process. Objective: Assess physicians' values and attitudes when helping patients choose an AA treatment. Methods: Semi-structured qualitative interviews were conducted with dermatologists of varying practice type and location. Each interview was coded independently twice using inductive thematic analysis. Interrater reliability and code frequencies were determined. Results: Fourteen participants were interviewed. Interrater reliability was κ = 0.85 to 0.97. Dermatologists wanted patients to consider various treatment factors (ie, efficacy, safety, convenience of use, accessibility) and also assessed patients' AA clinical severity and personality traits. Participants often encountered various barriers to effective communication with patients, which may be mitigated by shared decision-making. Shared decision-making tools were perceived to potentially improve patient care and communication, although physicians expressed concern about lack of individualization, limitations of time, and the appropriateness of information. Conclusion: AA treatment decision-making is a complex process that often utilizes the expertise of a dermatologist, during which shared decision-making tools may be of value to both patients and physicians.

Factors influencing alopecia areata treatment decisions: A qualitative assessment.

Background: Alopecia areata (AA) is a disease of hair loss in which patients may benefit from comprehensive understanding of AA's disease process and therapeutic options during treatment decision-making. Objective: Determine factors influencing patients' AA treatment decision-making. Methods: Qualitative interviews were conducted using semi-structured interview guides. Interviews were coded using inductive thematic analysis. Results: Twenty-one participants with AA were interviewed. Coding interrater reliability was κ = 0.87-0.91, indicating strong-almost perfect agreement. Participants faced multiple barriers, including lack of access to health care (n = 10, 47.6%) and lack of transparency about their condition and treatment options (n = 9, 42.9%). Information about AA was sought from primarily the internet (n = 15, 71.4%) and physician recommendation (n = 15, 71.4%). When choosing AA treatments, patients often considered treatment efficacy (n = 21, 100%), safety (n = 21, 100%), and convenience of use (n = 20, 95.2%). Limitations: Referral and regional biases may be present and limit generalizability. Conclusions: Patients with AA face various challenges including medical uncertainty and lack of information. Patients need trustworthy and accessible sources of information regarding their treatment that also take into consideration their preferences and values.

Association between alopecia areata, anxiety, and depression: A systematic review and meta-analysis.

BACKGROUND: To date, there is no comprehensive meta-analysis analyzing the association between alopecia areata, anxiety, and depression. OBJECTIVE: We sought to analyze the existing literature to examine the association between alopecia areata, anxiety, and depression. METHODS: We extracted literature from 4 databases including MEDLINE, Embase, PsychINFO, and Web of Science. We used the Preferred Reporting Items for Systematic Reviews and Meta-analyses (ie, PRISMA) reporting guidelines to finalize a list of relevant articles to be included in our systematic review and meta-analysis. There were no restrictions placed on publication year or age of participants. RESULTS: Eight studies that included 6010 patients with AA and 20 961 control individuals were included in the quantitative analysis. These included 4 cross-sectional studies and 4 case-control studies. Analysis of these studies showed a positive association with anxiety (pooled odds ratio, 2.50; 95% confidence interval, 1.54-4.06) and depression (pooled odds ratio, 2.71; 95% confidence interval, 1.52-4.82). LIMITATIONS: Publication bias may be a limitation of the study. CONCLUSION: This study suggests that patients with AA are at higher risk of both anxiety and depression. Health care professionals must be cognizant of this higher risk and consider routine assessment of these conditions and referral to appropriate providers when indicated.