Severity Of Alopecia Tool Score Research Articles

Exploring Janus kinase inhibitors for alopecia areata: a comprehensive review.

Alopecia areata poses a significant challenge due to its chronic autoimmune nature, leading to psychosocial impacts. Recent strides in understanding the disease have spotlighted Janus kinase (JAK) inhibitors as potential therapies. This comprehensive review aims to assess Baricitinib's efficacy and safety in treating scalp, eyebrow, and eyelash alopecia areata, and compare the effectiveness of Ritlecitinib and Brepocitinib. Conducting a thorough electronic literature search, we focused on clinical studies of JAK inhibitors for moderate to severe alopecia areata from 2015 onward. Key databases, including MEDLINE, PubMed, Cochrane Library, EMBASE, Google Scholar, and Medscape, were utilized. Primary outcomes included changes in the Severity of Alopecia Tool (SALT) score, with safety data evaluating adverse events and serious adverse events. The risk of bias was assessed using the Cochrane Risk of Bias Tool. Among the twelve studies identified, Baricitinib demonstrated superior efficacy over placebo at 24 weeks, with both 2mg and 4mg dosages significantly reducing SALT scores. Comparative efficacy at 24 weeks for Baricitinib, Brepocitinib, and Ritlecitinib showed similar effectiveness compared to placebo, with a marginal superiority observed for Baricitinib 4mg. All JAK inhibitors were well-tolerated, with reported adverse events primarily being mild and manageable. Collectively, the reviewed studies affirm JAK inhibitors, particularly Baricitinib, as promising treatments for moderate to severe alopecia areata. These inhibitors exhibit superior efficacy, as indicated by notable reductions in SALT scores, and are well-tolerated, with predominantly mild and manageable adverse events.

Safety and efficacy of tofacitinib in 97 alopecia areata patients.

Alopecia areata (AA) is a recurrent immune-mediated disorder causing hair loss without any scarring being present. It affects hairs on the head or other parts of the body and can occur at any age and in both genders. It seems that AA is associated with a higher rate of psychological disorders resulting from hair loss and the esthetic and social repercussions of it. Common treatments like corticosteroids do not work for every patient and recent treatment options focusing on the immunologic mechanisms like tofacitinib have shown some promising results. It's a retrospective study on patients with AA, AT, AU taking oral tofacitinib as a treatment for at least 6 months. Scalp hair loss was assessed before treatment and at each visit using the Severity of Alopecia Tool (SALT) score. Of 97 cases, 69.1% demonstrated over 50% SALT score improvement, with 44.3% having 90% or more decrease in SALT score. Patients who suffered from patchy AA were more responsive compared to patients with AT and AU subtypes and had a greater percent change in SALT score. Tofacitinib was tolerated quite well and no significant adverse events were reported. Tofacitinib should be taken into consideration as an efficacious treatment option for patients with AA, AT and AU.

Using artificial intelligence to compute Severity of Alopecia Tool scores

Using artificial intelligence to compute Severity of Alopecia Tool scores

Baricitinib Demonstrates Rapid Action Within Just 2 Months of Treatment in Severe and Unresponsive Alopecia Areata: A Case Report

Alopecia areata (AA) is a form of nonscarring alopecia, and is the most common immune-mediated cause of hair loss worldwide. Numerous therapeutic schedules available as off-label options have demonstrated only limited results. However, in 2022, baricitinib, a selective JAK1 and JAK2 inhibitor, was approved as an oral administered systemic therapy for severe AA. Based on this, the authors used it in a 21-year-old White female, who presented with a 15-year history of severe AA (Severity of Alopecia Tool score [SALT]: score 88) and immense psychological burden. After laboratory examinations within normal limits, baricitinib was administered as monotherapy with a 4 mg daily dosage. The severe AA improved rapidly after the first month, and resulted in total hair restoration just after the second month under baricitinib treatment. Besides clinical improvement, SALT score impressively reduced to 30 and 10, respectively, in 2 and 6 months. Six months later, the patient is keeping up the same treatment with no sign of relapse, and is on a 2-month follow-up schedule. In the authors’ patient, almost total hair restoration was achieved in less than 3 months of treatment, which strongly advocates for the addition of baricitinib in the dermatologic armament as a safe, adequate, and fast AA remedy.

Real-World Assessment of Disease Characteristics and Clinical Outcomes in Alopecia Areata in a Global Noninterventional Observational Cohort (ADAAGIO)

Background: A range of medications with varying efficacy are used to treat alopecia areata (AA). There remains limited evidence on prevailing treatments, disease characteristics, and clinical outcomes of patients with AA in routine practice, particularly for those with extensive hair loss. This study sought to address this evidence gap.
 Methods: This was a retrospective chart review study spanning the United Kingdom, France, Spain, and Germany. Adult and adolescent patients with ≥50% scalp hair loss were included. The study index date was defined as date of de novo or progression to ≥50% scalp hair loss and patients were required to have ≥6 months of postindex follow-up (i.e., index date to last clinic visit); index dates ranged 2015-2019. Analyses were descriptive and reported patient demographics, baseline clinical characteristics, and Dermatologic Life Quality Index (DLQI) score. The primary clinical endpoint was absolute Severity of Alopecia Tool (SALT) score and was assessed longitudinally based on post-index visits in which SALT was recorded. Sustained SALT ≤20 was also assessed via Kaplan-Meier methods to evaluate time to achieving SALT ≤20 without subsequent regression within 6 months to SALT >30.
 Results: A total of 741 patients were included. Median age at AA diagnosis was 27 years and 52.6% were female. Mean (SD) baseline SALT score at index was 63.5 (15.6), with 80.2% having patchy AA and 19.8% having alopecia totalis or universalis. Among patients with DLQI measured at index, mean (SD) DLQI score was 19.2 (7.2) with 84.5% reporting either a large (DLQI 11-20) or extremely large (DLQI 21-30) impact of AA. Topical corticosteroids were the most common treatment observed post-index, with 55.6% receiving ≥1 course with a median cumulative exposure of 4 months. Intralesional corticosteroids (22.5%), systemic immunosuppressants (22.0%), and oral (17.3%) or topical (19.4%) minoxidil were also common. Among patients with SALT measured at 12 months post-index, there was a mean (SD) absolute SALT reduction of -44.6% (37.3%) from baseline. However, at 12 months post-index, most patients (90.1%) failed to achieve SALT ≤20 that was sustained for ≥6 months.
 Conclusions: Although patients in this study experienced a substantial absolute SALT score reduction, few patients achieved and subsequentially sustained the more clinically meaningful SALT threshold of ≤20. These findings highlight the potential suboptimal effectiveness of the varied treatments applied in this population.

Long-term efficacy and safety of baricitinib in patients with severealopecia areata: 104-week results from BRAVE-AA1 and BRAVE-AA2.

Efficacy of the Janus kinase (JAK) inhibitor baricitinib for severe alopecia areata (AA) continuously increased over 52 weeks in two Phase 3 trials. There are limited long-term data on JAK inhibitors in AA. To evaluate efficacy and safety of baricitinib for severe AA through 104 weeks of continuous therapy. Integrated data from the BRAVE-AA1 and BRAVE-AA2 Phase 3 trials included adults with Severity of Alopecia Tool (SALT) scores ≥50 (≥50% scalp hair loss) randomized to and continuously treated with 2-mg or 4-mg baricitinib through Week 104. Patients who qualified to remain on continuous treatment included subjects who achieved SALT score ≤20 at Week 52 (Week-52 responders; 2-mg: N = 65; 4-mg: N = 129) and baricitinib 4-mg-treated patients who had SALT score >20 at Week 52 but achieved SALT score ≤20 at prior visit(s) and/or had significant improvement in eyebrow or eyelash hair growth relative to baseline by Week 52 (Week-52 mixed responders; N = 110). Week-104 outcomes included the proportion of patients achieving SALT score ≤20 (≤20% scalp hair loss). Data were censored after treatment discontinuation. Among baricitinib 4-mg-treated and baricitinib 2-mg-treated Week-52 responders, 90.7% and 89.2%, respectively, maintained SALT score ≤20 at Week 104. Among Week-52 mixed responders, 39.1% reached SALT score ≤20 by Week 104. Continued improvement in eyebrow and eyelash regrowth was observed across groups. The most frequent treatment-emergent adverse events were COVID-19, upper respiratory tract infection, headache, nasopharyngitis, acne, urinary tract infection and creatine phosphokinase increase. Baricitinib demonstrated a high level of maintenance of efficacy over 104 weeks in patients with severe AA. Efficacy increased in Week-52 mixed responders, illustrating that long-term treatment is necessary to observe maximum benefit in some patients. No new safety signals were observed.

Moving Beyond Boundaries: Utilization of Longitudinal Exposure-Response Model for Bounded Outcome Score to Inform Decision Making in the Accelerated Drug Development Paradigm.

As drug development scientists strive to accelerate availability of therapies for patients, model-informed drug development (MIDD) plays an important role in contextualizing existing information and facilitating decision making. This paper describes an example of MIDD, where modeling and simulation informed decision making in the circumstance of a combined phase 2b and single pivotal study for ritlecitinib (JAK3/TEC family kinases inhibitor). Longitudinal exposure-response (ER) modeling was conducted to describe ritlecitinib efficacy in alopecia areata patients. The Severity of Alopecia Tool (SALT) score (a continuous bounded outcome [CBO] score [0-100]) was used as the efficacy response. The average concentration during the time interval between two adjacent SALT scores was used as the exposure metric driving efficacy. The developed model well described the longitudinal SALT profile of ritlecitinib as well as the frequency of boundary data. The CBO model indicated tested doses in the phase 2b/3 clinical trial are in the ascending region of ER and contextualized a loading dose effect that impacted onset of efficacy without long-term benefit. It also identified disease severity as the only covariate impacting efficacy. The model-based simulation further informed impact of treatment interruption on the loss of efficacy in the absence of a dedicated treatment withdrawal study. Results indicated temporary treatment interruption ≤ 6 weeks is not expected to result in significant loss of efficacy. The CBO modeling approach and simulation supported the single pivotal trial strategy and guided dose selection in the accelerated drug development program of ritlecitinib, which can be applied to many indications where efficacy is measured on a bounded scale.

Evaluating the Effect of the Demographic, Trichoscopic and Laboratory Characteristics on The Recurrence of Alopecia Areata.

Alopecia areata (AA) has diverse disease characteristics and multiple factors may interfere with the prognosis of the disease. In this study, the factors affecting the AA recurrence were evaluated. A total of a hundred patients diagnosed with AA between June 2022 and March 2023 were included in this retrospective, cross-sectional study. The patients were divided into two groups according to the presence of outbreaks. Both groups were compared in terms of age, gender, disease duration, number of outbreaks, family history of AA, previous medical treatment history for AA, clinical type, disease severity, presence of accompanying nail findings, and trichoscopic and laboratory characteristics. Among 100 patients, male dominance was found (N = 69). Most of the patients had patchy disease (90/100), mild disease severity (88/100), and a solitary outbreak (65/100). Male gender, longer disease duration, family history, presence of S2 severity of alopecia tool score, trachyonychia, short vellus hairs in trichoscopic examination, hypothyroidism, and folic acid deficiency were factors for AA outbreaks. Male gender and the presence of a family member with AA in the family were defined as the independent prognostic factors for disease recurrence. While demographic, laboratory, and clinical findings are factors for AA outbreaks in the follow-up, male gender and family history should be considered independent predictors.

Visualizing Severity of Alopecia Tool (SALT) scores in the clinical setting using patient images from a clinical trial

AbstractBackgroundThe Severity of Alopecia Tool (SALT) is a standardized method for quantifying scalp hair loss in alopecia areata (AA). SALT scores can be used to guide treatment decisions and are widely used as eligibility criteria and endpoints for clinical trials in AA. However, clinicians may be unfamiliar with assessing and envisioning SALT scores in practice.ObjectivesTo aid clinicians in the determination and application of SALT scores in a clinical setting, this manuscript seeks to contextualize SALT scores using patient images from a clinical trial of adults with severe AA.MethodsImages from 722 patients enrolled in BRAVE‐AA1, a phase 2/3 study of baricitinib in adults with severe AA (SALT score ≥50; ≥50% scalp hair loss), were obtained at baseline and Weeks 12, 36, and 52 and compiled into a repository. Photographs were selected to represent SALT scores across the full range of disease (SALT scores 0–100) and to demonstrate the progression of SALT scores during the course of treatment.ResultsImages of six patients depict the range of SALT scores (0–100). Photographs are of male and female patients of different ages (21–69) and races (Asian, Black, White) with varying extent, density, and patterns of hair loss. Images of two additional patients demonstrate the use of SALT to monitor treatment progress, showing distinct patterns and timing of clinical response over 52 weeks of therapy.ConclusionsThe SALT is widely used in clinical trials for AA, but clinicians may lack familiarity. Presented patient images show SALT scores commonly used as eligibility criteria and endpoints in clinical trials, which may be useful in identifying patients eligible for systemic treatment and in visualizing therapeutic response.

Is thyroid dysfunction a common cause of telogen effluvium?: A retrospective study.

Telogen effluvium (TE) is a common cause of hair loss characterized by excessive resting hair shedding. Thyroid dysfunction is one of the possible causes of TE. On the other hand, the link between thyroid disorder and TE is still being debated. The aim of this retrospective is to investigate the link between thyroid dysfunction and TE. This retrospective study included 500 female patients with TE who had thyroid function testing between January 2012 and December 2022. Patients were eligible if they had a confirmed TE diagnosis and thyroid function tests within 3 months of being diagnosed with TE. The thyroid function of the participants was classified as euthyroid, hypothyroidism, or hyperthyroidism. The severity of hair loss was determined using the severity of alopecia tool (SALT) score. The study included 500 TE females, 248 of whom were euthyroid, 150 had hypothyroidism, and 102 had hyperthyroidism. The hypothyroid group had a significantly higher mean SALT score than the other 2 groups. Furthermore, patients in the hypothyroid group had a higher proportion of severe hair loss. The mean SALT score did not differ significantly between groups with normal thyroid function and those with hyperthyroidism. A common cause of TE is thyroid dysfunction, particularly hypothyroidism. Patients with hypothyroidism have more severe hair loss than those with normal thyroid function or hyperthyroidism. To effectively identify and manage such cases, thyroid function testing should be included in the diagnostic workup of patients with TE.

European expert consensus statement on the systemic treatment of alopecia areata.

Alopecia areata is an autoimmune form of non-scarring hair loss. It is usually characterized by limited areas of hair loss. However, the disease may progress to complete scalp and body hair loss (alopecia totalis, alopecia universalis). In patients with alopecia areata hair loss significantly impacts the quality of life. Children and adolescents with alopecia areata often experience bullying, including physical aggression. The disease severity evaluation tools used in clinical practice are: the Severity of Alopecia Tool (SALT) score and the Alopecia Areata Scale (AAS). A SALT score equal to or greater than 20 constitutes a commonly accepted indication for systemic therapy in alopecia areata. When using the AAS, moderate to severe alopecia areata should be considered a medical indication for systemic treatment. Currently, the only two EMA-approved medications for alopecia areata are baricitinib (JAK 1/2 inhibitor) for adults and ritlecitinib (JAK 3/TEC inhibitor) for individuals aged 12 and older. Both are EMA-approved for patients with severe alopecia areata. Other systemic medications used off-label in alopecia areata include glucocorticosteroids, cyclosporine, methotrexate and azathioprine. Oral minoxidil is considered an adjuvant therapy with limited data confirming its possible efficacy. This consensus statement is to outline a systemic treatment algorithm for alopecia areata, indications for systemic treatment, available therapeutic options, their efficacy and safety, as well as the duration of the therapy.

Treatment preferences of adults and adolescents with alopecia areata: A discrete choice experiment.

PRODUCTS with janus kinase (JAK) inhibition have been shown to promote hair regrowth in patients with alopecia areata (AA). To guide drug-approval and treatment decisions, it is important to understand patients' willingness to accept the potential risks of JAK inhibition in exchange for potential benefits. We quantified the treatment preferences of adult (≥18 years) and adolescent patients (12-17 years) with AA in the US and Europe to determine the trade-offs they are willing to make between benefits and risks. Preferences for oral AA treatment attributes were elicited using a discrete choice experiment consisting of 12 tasks in which patients chose between two hypothetical treatment alternatives and no treatment. Benefits included the probability of 80%-100% scalp hair regrowth (Severity of Alopecia Tool score ≤ 20) and achieving moderate-to-normal eyebrow and eyelash hair. Treatment-related risks included 3-year probabilities of serious infection, cancer, and blood clots. Preference estimates were used to calculate the maximum level of each risk that patients were willing to accept for increases in treatment benefits. The most important attribute to both adults (n = 201) and adolescents (n = 120) was a 50% probability of achieving hair regrowth on most or all the scalp; however, adolescents placed greater relative importance on this attribute than did adults. Adults were averse to the risks of serious infection, cancer, and blood clots, whereas adolescents were averse to the risk of cancer. For a 20% increase in the probability of 80%-100% scalp hair regrowth, adults were willing to accept a mean (95% confidence interval) 3-year risk of serious infection, cancer, and blood clots of 7.4% (5.5-9.3), 2.5% (1.9-3.1), and 9.3% (6.4-12.2). Adolescents were willing to accept a 3-year risk of cancer of 3.3% (2.4-4.2). Patients with AA in the US and Europe are willing to accept substantial risks to obtain an effective treatment.

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

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 52weeks of treatment. This posthoc analysis was conducted with data from patients who were treated continuously for 52weeks with baricitinib 4mg or 2mg. 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 week52, 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. At week52, 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. 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. BRAVE-AA1, ClinicalTrials.gov number, NCT03570749, start date, 24September2018; BRAVE-AA2, ClinicalTrials.gov number, NCT03899259, start date, 8July2019.

Adiponectin serum levels and ADIPOQ (rs2241766) polymorphism in alopecia areata Egyptian patients

BackgroundAlopecia Areata (AA) is an acquired autoimmune form of non-scarring hair loss. Adiponectin and its gene polymorphism were related to many autoimmune disorders. ObjectiveAssessment of adiponectin serum levels and adiponectin gene (ADIPOQ) (rs2241766) Single Nucleoid Polymorphism (SNP) in AA patients and correlating the results with the disease severity in those patients. MethodsThis study included 75 AA patients and 75 age and gender-matched healthy subjects (controls). The severity of Alopecia Tool (SALT) score assessment to evaluate AA severity was done. Adiponectin serum levels by ELISA and ADIPOQ (rs2241766) SNP using PCR were performed. ResultsAdiponectin serum levels were significantly lower in AA patients than controls (p = 0.001). ADIPOQ (rs2241766) TG genotype and G allele were significantly predominant in AA patients increasing its risk by 5 and 4 folds (OR = 5.17, p = 0.001), (OR = 3.82, p = 0.001) respectively. Serum adiponectin levels were negatively correlated with SALT score (r = -0.435, p = 0.001) and associated with alopecia totalis (p = 0.016). ADIPOQ (rs2241766) TG genotype was significantly associated with low serum adiponectin levels and higher SALT score (p = 0.001). Study limitationsThe small sample size. ConclusionsADIPOQ (rs2241766) gene polymorphism (TG genotype and G allele) may modulate AA risk and contribute to the development of AA in Egyptian populations. Decreased circulating adiponectin levels may have a dynamic role in AA etiopathogenesis. Adiponectin serum concentration can be considered a severity marker of hair loss in AA.

Distribution of SALT scores by Therapeutic Tesponse in Patients with Severe Alopecia After 52 weeks of Baricitinib Therapy

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. 
 Funded by Eli Lilly and Company.

A Real-World Study of Steroid-Free Monotherapy with Tofacitinib in Severe and Therapy-Recalcitrant Alopecia Areata, Alopecia Totalis, and Alopecia Universalis Cases: A Retrospective Analysis.

Alopecia areata (AA) presents with noncicatricial alopecia and has multifactorial etiology. Janus Kinase inhibitors (JAKibs) with potential efficacy and favorable side-effect profile are the first class of drugs to receive FDA approval in AA. Our primary objective was to assess the complete response rates to tofacitinib monotherapy in severe and recalcitrant AA, alopecia totalis (AT), and alopecia universalis (AU) patients using the latest percentage change in Severity of alopecia tool (SALT) score. We also aimed to analyze the various systemic agents used by these patients prior to the use of tofacitinib. Institutional records of 17 patients with severe or refractory AA, AT, and AU treated with tofacitinib monotherapy were analyzed, retrospectively. The response to tofacitinib therapy was determined after calculating percentage change in SALT score. End of treatment was defined as the dose which resulted in a significant response (complete/near complete response was ≥75% hair regrowth from baseline as determined by SALT score). Majority of patients had severe AA (SALT ≥ 50) (n = 9/17, 52.94%), while five patients had AT and three had AU. All patients had received either systemic glucocorticoids (GCS), which included oral mini pulse (OMP) (n = 8), intravenous pulse steroids (n = 4), and daily oral GCS (n = 6) or immunosuppressive agents (ISAs) which included cyclosporine (n = 14) followed by methotrexate (n = 6) and azathioprine (n = 6). Mean SALT score prior to starting tofacitinib was 74.23. Mean dose of tofacitinib used was 13.23 mg (10-15 mg) and mean duration of treatment was 9.23 months. Latest percentage change of SALT score ranged from 70.58% to 100%, with an average of 91.47%. Most patients showed complete/near complete response (13/17, 76.47%). Tofacitinib was found to be safe and effective in severe/refractory AA, AU, and AT patients recalcitrant to other treatment modalities in our study. Further studies are needed to assess the effect of these targeted drugs on JAK-STAT expression or tissue cytokines involved in the pathogenesis of AA using immunohistochemistry.

Efficacy of Baricitinib in Patients with Various Degrees of Alopecia Areata Severity: Post-Hoc Analysis from BRAVE AA1 and BRAVE AA2.

Baricitinib, an oral selective JAK1/JAK2 inhibitor, is approved for the treatment of adults with severe alopecia areata (AA). To evaluate differences in response up to week 52 among subgroups based on the baseline severity of AA assessed with the Severity of Alopecia Tool (SALT) score. Data were pooled from BRAVE-AA1 and BRAVE-AA2, two randomized, placebo-controlled, phase 3 trials, which enrolled adults with a SALT score ≥ 50. Patients were subdivided by the degree of AA severity at baseline. Among the 855 patients treated with baricitinib 2mg and 4mg, improvements in scalp hair growth continued through to week 52. A superior response was observed in patients with a SALT score of 50-94 versus a score of 95-100. Patients on baricitinib 4mg had a faster and higher response rate compared to baricitinib 2mg. Across all degrees of severity for baricitinib 2mg and 4mg doses, the proportion of patients responding was yet to plateau up to week 52. Response to treatment was longer for patients with a baseline SALT score 95-100. Further studies are needed to analyze other parameters that may impact observed response rates.

When to expect scalp hair regrowth during treatment of severe alopecia areata with baricitinib: insights from trajectories analyses of patients enrolled in two phase III trials.

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. To examine whether different clinical response subgroups could be identified in baricitinib-treated patients with severe AA and factors that contribute to these subgroups. 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. 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. 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.

Hair Loss Profiles and Ritlecitinib Efficacy in Patients with Alopecia Areata: Post Hoc Analysis of the ALLEGRO Phase 2b/3 Study.

Ritlecitinib demonstrated efficacy in patients with alopecia areata (AA) in the ALLEGRO phase 2b/3 study (NCT03732807). However, hair loss presentation may vary based on location (e.g., scalp, eyebrow/eyelash, body). Here, we sought to identify distinct hair loss profiles at baseline and evaluate whether they affected the efficacy of ritlecitinib. Patients with AA aged ≥ 12years with ≥ 50% scalp hair loss were randomized to daily ritlecitinib 10mg (assessed for dose ranging only), 30 or 50mg (± 4-week, 200-mg loading dose), or placebo for 24weeks. Latent class analysis (LCA) identified hair loss profiles based on four baseline measurements: clinician-reported extent of scalp (Severity of Alopecia Tool score), eyebrow hair loss, eyelash hair loss, and patient-reported body hair loss. Logistic regression evaluated ritlecitinib (50 and 30mg) efficacy vs placebo using Patient Global Impression of Change (PGI-C) and Patient Satisfaction with Hair Growth (P-Sat; amount, quality, and overall satisfaction) responses at Week 24, adjusting for key covariates, including latent class membership. LCA identified five latent classes: (1) primarily non-alopecia totalis (AT; complete loss of scalp hair); (2) non-AT with moderate non-scalp involvement; (3) extensive scalp, eyebrow, and eyelash involvement; (4) AT with moderate non-scalp involvement;and (5) primarily alopecia universalis (complete scalp, face, and body hair loss). Adjusting for latent class membership, patients receiving ritlecitinib 30 or 50mg were significantly more likely to achieve PGI-C response (30mg: odds ratio, 8.62 [95% confidence interval, 4.42-18.08]; 50mg: 12.29 [6.29-25.85]) and P-Sat quality of hair regrowth (30mg: 6.71 [3.53-13.51]; 50mg: 8.17 [4.30-16.46]) vs placebo at Week 24. Results were similar for P-Sat overall satisfaction and amount of hair regrowth. Distinct and clinically relevant hair loss profiles were identified in ALLEGRO-2b/3 participants. Ritlecitinib was efficacious compared with placebo, independent of hair loss profile at baseline. ClinicalTrials.gov identifier, NCT03732807.

Could red and near-infrared emitting fabric technology improve the severity of psoriasis, polymorphous light eruption, and alopecia areata?

AimLow-level light therapy (LLLT) may offer an adjunctive therapeutic tool for inflammatory skin conditions. This pilot study assessed the efficacy of a red/near-infrared (NIR)-emitting fabric for psoriasis, polymorphous light eruption (PMLE), and alopecia areata (AA).MethodsFourteen patients (five with psoriasis, five with PMLE, and four with AA) were instructed to wear a red/NIR-emitting (Lumiton®) garment during the 12-week study. Efficacy was assessed subjectively by patient-reported improvement and objectively by the redness, thickness, and scale of elbow psoriasis plaques, the frequency of PMLE flares, and the Severity of Alopecia Tool (SALT) score.ResultsThree patients with psoriasis completed the study while two self-discontinued. The three patients who completed the study noted improvement and two had improvements in lesion redness, thickness, or scale, while one was clinically stable. Three patients with PMLE completed the study, and none had a disease flare during the study period. Three patients with AA completed the study: two reported disease improvement and all three had an improved SALT score.ConclusionUse of a wellness apparel that emits red and NIR light may be associated with improved disease severity in patients with mild elbow psoriasis, PMLE, and limited AA. Limitations of this study include continuation on topical, intralesional, or systemic medications and small sample size.