Litfulo (ritlecitinib) / Pfizer - LARVOL DELTA

Efficacy and Safety of Ritlecitinib in the Asian Subpopulation of the ALLEGRO-2b/3 and ALLEGRO-LT Clinical Studies for Alopecia Areata. (PubMed, J Dermatol) - P3 | "Overall, ritlecitinib 50 mg (±200-mg loading dose) demonstrated clinically meaningful and sustained efficacy through Month 24 in the Asian subpopulation, consistent with results in the overall population. Trial Registration: ClinicalTrials.gov: NCT04006457."

Journal • Alopecia • Immunology • JAK3

Advances in Janus Kinase Inhibitors for Vitiligo Treatment. (PubMed, Drug Res (Stuttg)) - "The first generation Janus kinase inhibitors, i.e., tofacitinib and ruxolitinib, inhibit a variety of Janus kinases, whereas the new generation Janus kinase inhibitors, such as ritlecitinib and upadacitinib, exhibit inhibitory effects only on specific Janus kinases; they are therefore selective as well as safer and more effective. In this review, we aim to provide an up-to-date view of vitiligo pathogenesis at the cellular, molecular, and genetic levels and further to elucidate the relationship between Janus kinase/signal transducer and activator of transcription signaling pathway components and vitiligo. Finally, we summarize currently market-approved and preclinical Janus kinase inhibitors, highlighting the latest advances in their clinical applications."

Journal • Dermatology • Immunology • Vitiligo

Real-world experience of JAK Inhibitors in eyebrow regrowth for alopecia areata: a retrospective single-center study. (PubMed, J Am Acad Dermatol) - No abstract available

Journal • Real-world evidence • Retrospective data • Alopecia • Immunology

Evidence Synthesis Gone Awry: The Perils of Aggregating Ineffective or Unsafe Doses in Alopecia Areata Reviews. (PubMed, Cureus) - "Using recent evidence syntheses in alopecia areata, we show how inclusion of small, underpowered dose strata and regimens that never advanced to pivotal trials or were not pursued for regulatory approval (for example, deuruxolitinib 4 mg twice‑daily {BID}, deuruxolitinib 12 mg BID, and ritlecitinib 200 mg loading doses) can distort pooled efficacy and safety estimates, elevate unapproved regimens in rankings, and invite inappropriate causal inferences. We outline key methodological safeguards and offer concrete recommendations as follows: prespecify exclusion or planned sensitivity analyses for unapproved doses, transparently report approval status and relevant regulatory actions (for example, clinical holds) alongside pooled safety estimates, avoid causal attributions from small strata and present uncertainty appropriately, and report sensitivity analyses that omit unapproved doses. Implementing these practices preserves the statistical advantages of meta-analysis..."

Journal • Alopecia • Immunology

Switching between Janus kinase inhibitors for treatment of alopecia areata: A Multi-Center Retrospective Review. (PubMed, J Am Acad Dermatol) - "Switching between JAKis appears to be a viable strategy for severe AA patients, especially those responding to prior JAKi. Prior response may help guide treatment sequencing."

Journal • Retrospective data • Alopecia • Immunology

Deuruxolitinib for Alopecia Areata. (PubMed, Skin Therapy Lett) - "Deuruxolitinib is the third oral JAK inhibitor approved for the treatment of severe AA, the others being baricitinib and ritlecitinib. Deuruxolitinib's mechanism of action, clinical efficacy, and safety profile in the treatment of AA are reviewed."

Journal • Review • Alopecia • Immunology • CD8 • IFNG • IL15

Oral JΑΚ Inhibitors in Vitiligo Treatment. (PubMed, Dermatol Ther (Heidelb)) - "Oral JAK inhibitors could present an effective and safe option for patients with vitiligo; however. there is a need for further long-term studies and more data about treatment procedures."

Journal • Review • CNS Disorders • Depression • Dermatology • Immunology • Mood Disorders • Psychiatry • Vitiligo

Real-world study of The efficacy and safety of The JAK inhibitor Baricitinib and Ritlecitinib for the treatment of severe alopecia areata (ChiCTR) - P=N/A | N=150 | Completed | Sponsor: The FIrst Affiliated Hospital, College of Medicine, Zhejiang University; The FIrst Affiliated Hospital, College of Medicine, Zhejiang University

New trial • Alopecia • Dermatology • Immunology

JAK-Inhibitors Beyond the Label: Emerging Applications in Dermatology. (PubMed, Medicina (Kaunas)) - "Materials and A literature search was conducted in PubMed to identify case reports and case series describing off-label dermatologic use of baricitinib, abrocitinib, upadacitinib, and ritlecitinib. Although our data is limited to case-based literature, this review highlights the broad off-label therapeutic potential of oral JAK inhibitors in dermatology. Their rapid onset of action, sustained clinical responses, frequent maintenance of remission after dose tapering or discontinuation and generally acceptable safety profile support their consideration as treatment options in selected patients."

Journal • Review • Alopecia • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

From immunological mechanisms to targeted therapies: a bibliometric analysis of vitiligo treatment research (2005-2025). (PubMed, Front Immunol) - "Immunomodulatory therapies, particularly JAK inhibitors, such as ritlecitinib, have emerged as a key focus in ongoing clinical trials. This multi-database analysis delineates the evolving landscape of vitiligo treatment research, characterized by expanding output and increasing focus on immune-targeted therapies. Persistent gaps in clinical evidence, especially regarding long-term outcomes and pediatric populations, underscore the need for continued high-quality clinical studies in this field."

Journal • Dermatology • Immunology • Pediatrics • Vitiligo • CD8 • IFNG

Responses to Tetanus and Meningococcal Vaccines in Patients with Alopecia Areata Treated with Ritlecitinib. (PubMed, Dermatol Ther (Heidelb)) - P3 | "Primary and secondary immune responses to the meningococcal and tetanus vaccines were observed in patients with AA during chronic ritlecitinib therapy, although the study was limited by the small sample size. The vaccines were well tolerated, no vaccine-related AEs were reported, and there was no exacerbation of underlying disease."

Journal • Alopecia • Immunology • Infectious Disease • Meningococcal Infections • Tetanus • JAK3

Comment on "Ritlecitinib in Alopecia Areata: A 24-Week Real-World Experience Contrasting JAK Inhibitor-Naïve and JAK Inhibitor-Experienced Patients". (PubMed, J Dermatol) - No abstract available

Journal • Real-world evidence • Alopecia • Immunology

Beyond Hair Regrowth: Interpreting the Psychosocial Impact of Ritlecitinib in Alopecia Areata. (PubMed, Int J Dermatol) - No abstract available

Journal • Alopecia • Immunology

Ritlecitinib Efficacious for Non-Segmental Vitiligo Across Various Subgroups (HCPLive) - "By the 24-week mark, the team highlighted numerical but statistically non-significant differences in subjects’ responses, specifically among certain subgroups. Yamaguchi et al observed increased rates of disease response among men versus women. These greater rates were also observed in individuals with Fitzpatrick skin types III–VI as opposed to I–II. Other subgroups in this category were those with facial BSA involvement of at least 0.5% versus less than 0.5%, patients without leukotrichia versus those with leukotrichia, and treatment-naïve individuals versus those previously given treatment."

P2b data • Vitiligo

Case Report: Successful treatment of pediatric alopecia universalis with ritlecitinib after failure of baricitinib. (PubMed, Front Med (Lausanne)) - "We report the first case of a Pediatric patient transitioning from baricitinib therapy to ritlecitinib, resulting in favorable clinical outcomes. We believe that the result represent a meaningful advance in our understanding of how to treat children with chronic severe AA and feel that this would be of substantial interest to the broad readership of Frontiers in medicine."

Journal • Alopecia • CNS Disorders • Immunology • Pediatrics

Ritlecitinib in Alopecia Areata: A 24-Week Real-World Experience Contrasting JAK Inhibitor-Naïve and JAK Inhibitor-Experienced Patients. (PubMed, J Dermatol) - "Importantly, no patients in both groups experienced SALT worsening or treatment-related adverse events. Our findings highlighted that ritlecitinib is highly effective especially in adolescent JAKi-naïve AA, and although the clinical effect may be limited in JAKi-experienced patients, switching from baricitinib to ritlecitinib remains one of the viable options due to its low risk of disease exacerbation."

Journal • Real-world evidence • Alopecia • Hepatocellular Cancer • Immunology • Oncology • Solid Tumor • JAK3

Efficiency and safety of JAK inhibitors for alopecia totalis and alopecia universalis (PubMed, Zhonghua Yi Xue Za Zhi) - "A total of 15 adverse events were reported, all of which were mild to moderate, with folliculitis (9/15) being the most common. Baricitinib and ritlecitinib are both effective and well-tolerated in treating alopecia totalis and universalis, demonstrating a manageable safety profile."

Journal • Retrospective data • Alopecia • Dermatology • Immunology

Utilization and Effectiveness of Ritlecitinib in a Real-World Population With Severe AA in the US (clinicaltrials.gov) - P=N/A | N=300 | Not yet recruiting | Sponsor: Pfizer | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Real-world evidence • Trial completion date • Trial primary completion date • Alopecia • Dermatology • Immunology

BH09 Rapid resolution of chronic spontaneous urticaria with ritlecitinib in a patient with alopecia universalis. (PubMed, Br J Dermatol) - "Initial management included high-dose fexofenadine, famotidine, montelukast and omalizumab...Pulsed dexamethasone provided modest improvement in her urticaria symptoms but did not alter the progression of her alopecia...While JAK inhibitors are not established as a standard treatment for CSU, limited case series have documented the use of tofacitinib in refractory cases...The rapid and sustained symptom resolution observed in this patient suggests the potential of ritlecitinib as a novel therapeutic option for refractory CSU. Further investigation is warranted to evaluate its broader clinical applicability and efficacy in CSU management."

Journal • Alopecia • Asthma • Chronic Spontaneous Urticaria • Dermatology • Endocrine Disorders • Immunology • Pulmonary Disease • Respiratory Diseases • Urticaria

BH08 Unprovoked pulmonary emboli in a patient with alopecia areata treated with ritlecitinib: a case report. (PubMed, Br J Dermatol) - "The efficacy of ritlecitinib, an oral Janus kinase 3/TEC family inhibitor, has been demonstrated in the Allegro clinical trials...The US Food and Drug Administration issued black box warnings, citing increased risks of major adverse cardiovascular events, malignancies, venous thromboembolism (VTE) and mortality based on data from tofacitinib, baricitinib and upadacitinib in rheumatoid arthritis...The patient received intravenous broad-spectrum antibiotics for sepsis of unknown origin, hydrocortisone and vasopressor support for hypotension. She was anticoagulated with dalteparin and transitioned to apixaban as per respiratory advice for unprovoked pulmonary emboli...This case highlights a probable severe adverse event associated with ritlecitinib therapy, including pulmonary emboli and infection of unidentified source, associated with new-onset atrial fibrillation and acute kidney injury in a patient without known risk factors for VTE. Ongoing pharmacovigilance is..."

Journal • Acute Kidney Injury • Alopecia • Atrial Fibrillation • Cardiovascular • Dermatology • Endocrine Disorders • Hematological Disorders • Herpes Zoster • Hypotension • Immunology • Infectious Disease • Inflammatory Arthritis • Influenza • Musculoskeletal Pain • Nephrology • Novel Coronavirus Disease • Oncology • Pain • Pneumococcal Infections • Pruritus • Pulmonary Embolism • Renal Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Septic Shock • Varicella Zoster • Venous Thromboembolism • CRP • JAK3

BH19 'JAK in the box?' Long-term safety concerns with oral Janus kinase inhibitors for alopecia areata. (PubMed, Br J Dermatol) - "The findings were synthesized to provide an overview of the safety profiles of baricitinib, ritlecitinib, deuruxolitinib, ivarmacitinib and other JAK inhibitors. Long-term safety data were scarce, with only one study (the phase IIb/III ALLEGRO trial on ritlecitinib) extending to 2 years, while others had follow-ups of 52 weeks or shorter...Given the chronic nature of AA and the potential for extended use of JAK inhibitors, further long-term studies are necessary to better assess the risks of malignancies, cardiovascular events and other rare but serious AEs associated with this drug class. Although short-term studies indicate efficacy and tolerability, the absence of longitudinal research underpins the need for cautious clinical use and informed patient decision making."

Journal • Review • Acne Vulgaris • Alopecia • Breast Cancer • Cardiovascular • Immunology • Infectious Disease • Melanoma • Myocardial Infarction • Oncology • Pain • Respiratory Diseases • Solid Tumor • Squamous Cell Carcinoma

Janus Kinase Inhibitors During Pregnancy and Adverse Drug Reactions: A Pharmacovigilance Disproportionality Analysis in VigiBase. (PubMed, Clin Transl Sci) - "This study analyzed VigiBase, the World Health Organization global pharmacovigilance database of individual case safety reports (ICSRs), to assess signals of disproportionate reporting (SDRs) for pregnancy-related adverse drug reactions (ADRs) reported with systemic JAKIs, including abrocitinib, baricitinib, deucravacitinib, fedratinib, filgotinib, itacitinib, momelotinib, pacritinib, peficitinib, ritlecitinib, ruxolitinib, tofacitinib, and upadacitinib. Findings should be interpreted cautiously given the limitations of spontaneous reporting systems and the exploratory nature of the analysis. Further studies are needed to better characterize the JAKI safety in pregnancy."

Adverse drug reaction • Adverse events • Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Response to Huang et al's ''Real-world efficacy of ritlecitinib in treating alopecia areata across various anatomical sites: Potential rapid response predictors". (PubMed, J Am Acad Dermatol) - No abstract available

Journal • Real-world evidence • Alopecia • Immunology

Ritlecitinib (PF-06651600) in Participants With Chronic Spontaneous Urticaria (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Ahuva D Cices | N=20 ➔ 0 | Initiation date: Sep 2025 ➔ Dec 2025 | Recruiting ➔ Withdrawn

Enrollment change • Trial initiation date • Trial withdrawal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Efficacy and safety of baricitinib treatment in alopecia areata: a retrospective analysis (PubMed, Orv Hetil) - "Our findings support the efficacy of baricitinib in the treatment of severe alopecia areata. Hair regrowth was observed in a substantial proportion of patients as early as the 3. month of therapy, with further improvement by month 12. Adverse events were mostly mild, leading to treatment discontinuation in only one case. Baricitinib appears to be an effective and safe therapeutic option for severe alopecia areata. Orv Hetil. 2025; 166(49): 1943-1948."

Journal • Retrospective data • Acne Vulgaris • Alopecia • Dermatology • Herpes Simplex • Immunology • Infectious Disease • Pain