Litfulo (ritlecitinib) / Pfizer - LARVOL DELTA

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

Ritlecitinib: Efficacy of a novel therapy for severe alopecia areata in patients aged 12 years and older. (PubMed, Actas Dermosifiliogr) - "Ritlecitinib, a JAK3/TEC kinase inhibitor, has recently been approved for the treatment of severe AA in patients aged 12 and older. This review analyses the mechanism of action of ritlecitinib and the evidence for its safety and efficacy profile in patients with severe AA."

Journal • Review • Alopecia • Immunology • JAK3

Mechanistic insights into Ritlecitinib-mediated immunomodulation in Alopecia Areata (ISDS 2025) - "Ritle exhibits therapeutic efficacy by modulating key T-cell populations, suppressing inflammatory and cytotoxic responses, and markers of follicular IP collapse. These findings provide mechanistic support for ritle as a targeted therapy for AA."

Immunomodulating • IO biomarker • Alopecia • Immunology • CD69 • CD8 • GZMB • IL2 • IRF4 • ITGAE • JAK3

A Study to Learn About Litfulo Capsule in People With Severe Alopecia Areata in Routine Clinical Practice. (clinicaltrials.gov) - P=N/A | N=3000 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2030 ➔ Mar 2030 | Trial primary completion date: Sep 2030 ➔ Mar 2030

Enrollment open • Trial completion date • Trial primary completion date • Alopecia • Dermatology • Immunology

B7981119: A 16-Week Study to Learn About the Study Medicine Called Ritlecitinib in Adults With Long Lasting Painful Red Skin Lumps, Known by the Medical Term, Hidradenitis Suppurativa, or HS. (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Hidradenitis Suppurativa • Immunology • Pain

JAK3/TEC Kinase Inhibition is Safe and Effective in Cicatricial Alopecias: Results from a Prospective Clinical Trial (ISDS 2025) - P2 | "Ritlecitinib had a favorable safety profile and demonstrated rapid improvements in clinical scores and molecular biomarkers, supporting JAK3/TEC inhibition as a potential therapeutic approach in treatment of cicatricial alopecia."

Clinical • Alopecia • Fibrosis • Immunology • Inflammation • Lichen Planus • CCL2 • CCL22 • COL1A1 • CXCL10 • CXCL9 • GZMB • IL12RB1 • IL16 • IL2RA • JAK1 • JAK3 • S100A12 • TAP1

HiJacK vitiligo: JAK3 and TEC family kinase inhibition in the pathogenesis and treatment of vitiligo (ISDS 2025) - "Therefore, this study aims to better understand the role of JAK3/TEC-family kinases in vitiligo and assess whether selective inhibition using ritlecitinib can provide a durable treatment option...The increased presence of JAK3/TEC kinase-expressing cells in vitiligo skin highlights their role in vitiligo pathogenesis. Both the in vitro and ex vivo analyses help to provide a better understanding of how targeting JAK3/TEC-family kinases could meet the requirements for an effective and durable repigmentation therapy for vitiligo."

Dermatology • Immunology • Vitiligo • IL15 • JAK3

Comparative Clinical, Trichoscopic, and Safety Outcomes of Baricitinib, Ritlecitinib, and Upadacitinib in Alopecia Areata: A Real-World Experience. (PubMed, Clin Exp Dermatol) - No abstract available

Journal • Real-world evidence • Alopecia • Immunology

Double Blind, Placebo-controlled Trial to Establish Safety and Efficacy of Ritlecitinib in Celiac Disease Patients in Remission (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Massachusetts General Hospital | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Celiac Disease • Immunology

Episodic Neuropathic-Like Musculoskeletal Pain Associated With Ritlecitinib Therapy in Alopecia Universalis: A Case Report. (PubMed, Cureus) - "While causality cannot be firmly established, this case raises the possibility of a novel treatment-related adverse effect that may significantly impair quality of life. These findings underscore the importance of ongoing pharmacovigilance as JAK inhibitors are increasingly utilized in alopecia management."

Journal • Allergy • Alopecia • Asthma • Atopic Dermatitis • Dermatology • Endocrine Disorders • Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Neuralgia • Pain • Pulmonary Disease • Respiratory Diseases

Pfizer showcases leading skin disease treatments at CIIE (China Daily) - "The company's Inflammation & Immunology unit presented Cibinqo and Staquis for atopic dermatitis, along with Litfulo for alopecia areata."

Clinical data • Alopecia • Atopic Dermatitis

A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults. (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A 16-Week Study to Learn About the Study Medicine Called Ritlecitinib in Adults With Long Lasting Painful Red Skin Lumps, Known by the Medical Term, Hidradenitis Suppurativa, or HS. (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Pfizer

New P2 trial • Dermatology • Hidradenitis Suppurativa • Immunology • Pain

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

New trial • Real-world evidence • Alopecia • Dermatology • Immunology

Real-World Effectiveness of JAK Inhibitors for Alopecia Totalis and Alopecia Universalis: A Single-Center Experience. (PubMed, J Cutan Med Surg) - "This study confirms the effectiveness and safety of JAK inhibitors for patients with AT and AU in a real-world setting. These findings align with clinical trial results and reinforce the JAK inhibitor's role as a viable treatment option for AA."

Journal • Real-world evidence • Alopecia • Immunology

Potential Role of Biomarkers in Approved and Investigational Drugs for Ulcerative Colitis: Step Towards Personalized Medicine (ACG 2025) - "Another study identified 37 serum proteins that significantly changed at week 8 (P< 0.05) to predict clinical efficacy to ritlecitinib. Clinical decision support tool (VDZ-CDST) was also developed to identify patients most appropriate for vedolizumab (AUC=0.72, 95% CI 0.64-0.79).Next, we reviewed trial designs of both approved and investigational drugs... We evaluated 15 PM studies in UC, of which 5 had predictive biomarker assessments (Table 1). Two of these studies identified the role of gene expression. For mirikizumab, significant reduction in transcripts (drug resistance signature) of TNF receptor was noted; while for golimumab, patients with identified gene expression signature had mucosal healing at week 6 AUCROC 0.69 (P=0.002)."

Biomarker • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Vitiligo: Ruxolitinib and Other Oral Treatment Options Beyond Ruxolitinib. (PubMed, Skin Res Technol) - "Advances in systemic and topical JAK inhibitors have shown promising repigmentation effects in vitiligo, particularly for localized facial lesions. Ruxolitinib cream, the first FDA-approved therapy, and other JAK inhibitors highlight a growing therapeutic approach, with ongoing trials needed to optimize efficacy and evaluate long-term safety. Combination therapy with phototherapy shows enhanced repigmentation outcomes."

Journal • Review • Acne Vulgaris • Dermatology • Hematological Disorders • Immunology • Mood Disorders • Neutropenia • Vitiligo

Real-world efficacy and safety of ritlecitinib combined with phototherapy in refractory vitiligo: A single-centre experience. (PubMed, J Am Acad Dermatol) - No abstract available

Journal • Real-world evidence • Dermatology • Immunology • Vitiligo

Deuruxolitinib (Leqselvi) for severe alopecia areata. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Alopecia • Immunology