Rodney D. Sinclair

Alopecia areata (AA) has a high prevalence worldwide and causes considerable morbidity in patients. Patient-reported outcomes (PROs) have become an important component of clinical outcome assessment. The quality of existing AA-specific PRO measures (PROMs) has not been evaluated to date. To identify and critically appraise the quality of the measurement properties of existing AA-specific PROMs and provide evidence-based recommendations on the most valid PROMs. Using the predefined eligibility criteria, a systematic search was undertaken using 3 databases to screen the literature for available AA-specific PROMs after 2000. Original developmental studies and related validation studies that reported at least 1 measurement property of the primary PROM were retrieved. The Consensus Based Standards for the Selection of Health Measurement Instruments guidelines were used to examine the quality of the psychometric properties of retrieved PROMs. The quality of evidence was graded using the Grading of Recommendations Assessment, Development and Evaluation approach. Data were analyzed from April to July 2024. A total of 15 articles were identified, including 8 developmental studies (describing 11 PROMs) and 7 validation studies. Three PROMs (Scale of Alopecia Areata Distress, Alopecia Areata Quality of Life Index, and Alopecia Areata Patients' Quality of Life) were AA-specific health-related quality-of-life instruments. Five instruments were single-item symptom-based PROMs (PRO measures for eyebrow, eyelash, nail appearance, and eye irritation, and Scalp Hair Assessment PRO). Three PROMs (Alopecia Areata Patient Priority Outcomes [AAPPO], Alopecia Areata Severity Self-Assessment, and Alopecia Areata Symptom Impact Scale) were based on both constructs. All PROMs were developed based on adult individuals. Seven PROMs (Scale of Alopecia Areata Distress, AAPPO, and all 5 symptom-based PROMs) featured very good development design. Content validity was the most frequently reported measurement property, rated to be sufficient for 8 PROMs. Internal consistency was reported for 5 PROMs with sufficient quality. AAPPO was the only PROM with high-quality evidence of sufficient structural validity and internal consistency. AAPPO was also the only PROM assessed for test-retest reliability, which was judged to be sufficient. No study reported measurement error. This systematic review shows that there is still an unmet need for high-quality validation studies on the internal structure of AA-specific PROMs. Recommendations have been provided to help improve the rigor of the validation of AA-specific PROMs. Use of standards in psychometric testing of instruments could enhance the quality of instruments.

We report a rare case of scalp hair repigmentation after radiotherapy in a 76-year-old male. The patient had grey scalp hairs for over a decade, and was treated with radiotherapy, 45 Gy delivered over 25 fractions, for squamous cell carcinoma of the scalp and neck. He subsequently underwent a period of radiotherapy-induced alopecia and when his hair regrew four months later it was unexpectedly coloured orange to brown, his natural hair colour in his youth. There are limited reported cases of this phenomenon. This report adds to the limited literature, highlighting the role of hair follicle melanocytes and melanocyte stem cell plasticity in hair colour restoration, and how factors such as radiation may influence it.

Background: We report pooled safety data for baricitinib treatment of severe alopecia areata in patients in BRAVE-AA1 (phase II/III) and BRAVE-AA2 (phase III), including data from the long-term extension and bridging extension periods. Methods: Data are reported from the extended dataset (patients receiving continuous baricitinib 2 mg or 4 mg) and the all-baricitinib dataset (all patients receiving any dose of baricitinib at any time during the trials). Safety outcomes include treatment-emergent adverse events, adverse events of special interest, and abnormal changes in laboratory test results. Incidence rates (IRs) per 100 patient-years were calculated based on time at risk. Data cutoff dates were 22 May, 2023, for BRAVE-AA1 and 8 May, 2023, for BRAVE-AA2 and included follow-up through at least 152 weeks. Results: Data were collected for 1303 patients treated with baricitinib, reflecting 2789.7 patient-years of exposure (median, 825 days; maximum, 1460 days). Most treatment-emergent adverse events were mild to moderate in severity. Incidence rates of serious adverse events (IR = 2.6) and treatment discontinuations because of adverse events (IR = 1.7) were generally low and remained similar to data presented through at least 104 weeks of follow-up. In an additional 1 year of follow-up, no new cases of serious infections, opportunistic infections, major adverse cardiovascular events, deep vein thromboses, or pulmonary embolisms were observed. The IRs for non-melanoma skin cancer (IR = 0.1) and other malignancies (IR = 0.2) remained stable over time. The IR of herpes zoster was comparable to previously reported IRs (IR = 1.9). Laboratory changes were generally consistent over time. No deaths were reported in either study. Conclusions: Long-term safety data from BRAVE-AA1 and BRAVE-AA2 are consistent with previously reported data from the baricitinib alopecia areata clinical trial program and demonstrate no new safety concerns or signals for baricitinib through a maximum exposure of 4 years. Background: BRAVE-AA1 (NCT03570749) and BRAVE-AA2 (NCT03899259) were registered on 18 June, 2018, and 1 April, 2019, respectively.

Guttate psoriasis is a psoriasis subtype often triggered by infections that may progress to chronic plaque psoriasis. While some cases resolve on their own, severe cases can be challenging to manage. Our case, along with recent reports, suggests that interim treatment with biologics such as IL-17 and IL-23 inhibitors may induce long-term remission. Further research is needed to explore the potential role of biologics as a therapeutic option for this condition.

A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin)

A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata

An Open-Label, Phase 2, Pilot Study Investigating the Safety, Clinical Activity, Pharmacokinetics, and Pharmacodynamics of Oral Treatment With the BTK Inhibitor PRN1008 in Patients With Newly Diagnosed or Relapsing Pemphigus Vulgaris

A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate to Severe Atopic Dermatitis

A Phase 1, Randomized, Two-Part, Double-Blind, Placebo-Controlled, Dose-Escalation, Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AK120 in Healthy Subjects and Subjects With Moderate- to- Severe Atopic Dermatitis