Severity Of Alopecia Tool Score Research Articles

The Role of 5% Minoxidil versus Platelet-Rich Plasma in Treatment of Alopecia Areata.

To compare the efficacy of topical minoxidil and platelet-rich plasma (PRP) in the treatment of alopecia areata (AA). Randomised control trial. Place and Duration of the Study: Department of Dermatology, Jinnah Postgraduate Medical Centre, Karachi, Pakistan, from December 2021 to June 2022. The study included all the patients who visited JPMC Karachi during the study period. Permission from the ERB was obtained. The inclusion criteria were any gender and age 10 to 45 years. Topical minoxidil 5% solution was applied twice daily to Group A (six pubs/time), while PRP injections were administered to Group B at baseline and every four weeks for three months. Serial photos and the severity of alopecia tool (SALT) were used to determine the clinical assessment. When comparing the effectiveness between the two groups, a p-value of <0.05 was considered significant. SPSS version 23 was used to analyse the data. Mean age was 23.11 ± 8.9 years in 376 patients. PRP and Minoxidil groups had mean SALT scores at three months that were 1.48 and 1.54, respectively. Both treatments were shown to be efficacious. There was no statistically significant difference in efficacy between the minoxidil solution and PRP (p = 0.483). There is no apparent difference between PRP and topical minoxidil 5% solution in the management of AA. To verify the results, additional studies are needed with a larger sample size and a longer duration of follow-up. Minoxidil, Platelet-rich plasma, Alopecia areata, Severity of alopecia tool score.

Determining meaningful thresholds for evaluating treatment efficacy in patients with alopecia areata

AbstractBackgroundThe Severity of Alopecia Tool (SALT) is a clinician‐reported outcome measure of scalp hair loss in alopecia areata (AA).ObjectivesTo characterise the magnitudes of change in SALT scores corresponding to meaningful treatment benefits from the patient's perspective.MethodsAnchor‐based methods for the estimation of meaningful within‐patient change thresholds were applied to pooled data from a randomised, double‐blind trial of ritlecitinib. Anchors included a patient‐reported measure of change in AA severity, the Patient Global Impression of Change (PGI‐C) and three items comprising the Patient Satisfaction with Hair Growth (P‐Sat) questionnaire. After reviewing Pearson correlations between change‐from‐baseline SALT scores and each anchor to confirm adequate association, potential thresholds were computed as mean change‐from‐baseline SALT scores among patients who reported moderate improvement on the PGI‐C and/or moderate satisfaction on each of three P‐Sat items at week 24.ResultsSix hundred and fifty participants (86% adults, 14% adolescents) had mean (standard deviation) SALT scores of 90.6 (14.3) at baseline, suggesting a sample with primarily severe AA. Correlations between SALT change‐from‐baseline scores and the patient‐reported items supported their use as anchors. Estimates based on patients reporting moderate improvement in AA (n = 102) on the PGI‐C and those reporting moderate satisfaction on the P‐Sat item related to the amount of hair growth at week 24 (n = 122) were −42.2 (26.1) and −43.1 (26.8), respectively. Supportive estimates based on the remaining P‐Sat items were similar in magnitude.ConclusionsAmong patients with severe AA, SALT change‐from‐baseline scores of 42 or 43 represent meaningful improvements. While the achievement of low SALT scores of ≤10–≤20 have been used to characterise efficacy in clinical trials, the amount of change required to meet this endpoint far exceeds the estimates in this study. The treatment goals of individual patients must be considered when evaluating benefit in both clinical trials and clinical practice.

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.

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.

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.&#x0D; 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 &gt;30.&#x0D; 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.&#x0D; 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.

Treatment of moderate-to-severe alopecia areata in patients over the age of 65 years with baricitinib.

Baricitinib is a Janus kinase inhibitor that has been approved by the US Food and Drugs Administration for the treatment of severe alopecia areata (AA) in adults. However, the clinical trials that demonstrated the efficacy of baricitinib in the treatment of severe AA did not include men aged > 60 years or women aged > 70 years. We retrospectively assessed the efficacy and safety of baricitinib in 14 patients aged ≥ 65 years with moderate-to-severe AA. After a mean (SD) duration of 18.5 (11.9) months, a 72% reduction in mean Severity of Alopecia Tool score from baseline was observed. Partial or complete eyebrow and eyelash hair was observed in 57% and 43% of patients, respectively. The adverse effects of baricitinib were mild. No cases of venous thromboembolism, major adverse cardiovascular events or malignancy were reported.

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.

Evaluation of the Systemic Immune-Inflammatory Index and Its Relationship with Disease Severity in Patients with Alopecia Areata

Aim: Systemic Immune-Inflammatory Index (SII) is an index that assesses the systemic inflammatory response and has been increasingly used in recent times. The objective of this study is to evaluate the role of systemic inflammation in alopecia areata (AA) by examining the SII and to investigate its relationship with disease severity. Materials and Methods: This is a retrospective study in which SALT (Severity of Alopecia Tool) scores, SII values, and neutrophil-to-lymphocyte ratios (NLR) of patients diagnosed with AA and followed up at our clinic between January 2023 and March 2024 were evaluated. Results The study included a total of 153 patients with AA (99 males and 54 females) and 91 healthy controls. NLR in the patient group (2.24 ± 0.64) was significantly higher than in the control group (2.04 ± 0.54) (p = 0.013). SII in the patient group (593.38 ± 214.25) was also significantly higher than in the control group (497.26 ± 154.72) (p = 0.001). There was a significant positive, correlation between the SALT score and the NLR (p = 0.001). Similarly, there was a significant positive correlation between the SALT score and the SII (p = 0.001). The SII for the group with alopecia universalis was significantly higher than for other patient groups (p = 0.001). There was a positive, statistically significant relationship between disease duration and both the NLR and SII (p = 0.001 and p = 0.001). Conclusion: We observed elevated inflammatory parameters suggesting systemic inflammation in patients with AA. The NLR and SII were both higher in the patient group compared to the control group. Additionally, as the SALT score, increased, so did the levels of NLR and SII. We concluded that in addition to its diagnostic utility in AA, SII also serves as a biomarker that correlates with disease severity.

Evaluation of the Efficacy and Safety of Oral Tofacitinib for the Treatment of Alopecia Areata in Children

Alopecia areata (AA) is a common chronic relapsing nonscarring alopecia. Severe forms of AA commonly manifest during childhood. Treatment of AA is challenging due to the variability of the disease course as well as unpredictable responses to treatment. There is no uniform approved treatment for cure or sustained remission in children till now. Tofacitinib emerged as a novel drug in the treatment of AA, but few studies have been conducted on its safety and efficacy in children. Limitation of this study includes retrospective nature, small sample size, and lack of prolonged follow‐up. Aim. This retrospective study aimed to assess the efficacy and safety of oral tofacitinib in children with AA. Method. In this retrospective study, we included patients aged 18 years or younger with AA. The scalp blandness of included patients was greater than 20% and they were on oral tofacitinib for at least two months. The demographic data, clinical characteristics, tofacitinib efficacy, and adverse effects were recorded. The primary endpoint was the last recorded percent change in the Severity of Alopecia Tool (SALT) score during treatment. Results. We included 26 patients (12 males and 14 females) with AA with a mean age of 11.6 ± 4.42 (3–18) years. Eighteen of them were in the alopecia areata (AA) group, whereas eight patients had alopecia totalis (AT) or alopecia universalis (AU). The mean disease duration before starting treatment with tofacitinib was 3.9 ± 3.3 years. Most of the patients were on a tofacitinib daily dose of 5 mg (53.85%) and 10 mg (38.46%). Patients were on tofacitinib for 6.73 ± 3.79 months. The patients’ baseline SALT score was recorded as 68.58 ± 32.65 and the final SALT score was 17.65 ± 23.88. Thus, the patients achieved a 50.92% reduction in the SALT score. Interestingly, there were no statistically significant differences in clinical efficacy between subtypes of AA and AT/AU. Conclusion. Tofacitinib was significantly effective in treating AA and AT/AU in children, with mild tolerable adverse effects, although relapse during treatment and tapering was recorded. Future randomized clinical trials with longer follow‐up periods are needed to evaluate the safety of oral tofacitinib in children.

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.&#x0D; 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 &gt;20 at Week 52. Median and interquartile range (IQR) of SALT scores was assessed with last observation carried forward.&#x0D; 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.&#x0D; 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. &#x0D; Funded by Eli Lilly and Company.