Efficacy of Oral Tofacitinib in Moderate to Severe Alopecia Areata, Totalis and Universalis at Tertiary Care Hospital, Karachi.

Phase 3

Completed

• Conditions: Alopecia Universalis; Alopecia Totalis; Alopecia Areata
• Interventions: Drug: Tofacitinib

• Registration Number: NCT06278402
• Lead Sponsor: Jinnah Hospital

Brief Summary

To determine the efficacy of oral Tofacitinib in the treatment of moderate to severe alopecia areata, totalis and universalis at tertiary care hospital of Karachi, Pakistan. Efficacy of treatment in patients presenting with alopecia areata will be assessed using SALT Score on follow up at 6,12 and 24 weeks where four categories of treatment response were defined: 0 (re-growth ≤10%), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth \>75%). Efficacy will be considered if re-growth ≥ 2.

Detailed Description

Alopecia areata is a chronic, autoimmune, non-scarring alopecia that involves the destruction of hair follicles (HF) by autoreactive CD8+ T cells. AA can affect any hair-bearing region and can manifest in various patterns ranging from patchy diffuse alopecia to progression to more severe forms such as alopecia totalis (AT) or alopecia universalis (AU). As a common type of alopecia in human, the estimated prevalence of AA is approximately between 0.1% and 0.2%, second only to male and female pattern alopecia. Although it is not life threatening but the psychosocial impact of the disease is a concern. The treatment of advanced forms of alopecia areata (AA) is more challenging than the milder forms and patients with advanced AA often require systemic therapy in order to regrow hair.

Current treatments include steroids (intralesional, topical, and systemic), topical immunotherapy (diphenylcyclopropenone \[DPCP\], squaric acid dibutylester \[SADBE\]), topical immunosuppressants (tacrolimus, pimecrolimus), topical minoxidil, and topical prostaglandin analogs (bimatoprost, latanoprost).

Significant breakthroughs in understanding of intracellular cytokine signaling pathways have promoted a dawn of new promising therapeutic agents, known as Janus kinase inhibitors (JAKs), which block signaling of certain cytokines by inhibiting ATP binding within the phosphorylation sites of cytokine receptor homo- or heterodimers, thereby interrupting the JAK/signal transducer and activator of transcription (STAT) pathway and subsequently production of pro-inflammatory cytokines and other mediators associated with AA.

Despite the rapid development of novel JAK inhibitors, including baricitinib and ritlecitinib, tofacitinib remains an effective and the longest-used JAK inhibitor for AA. Tofacitinib primarily targets JAK 1/3 and reduces the immune response and resultant inflammation, emerging as an alternative for the treatment of refractory cases of AA.

In 2014, the first reported case using a JAK1/3 inhibitor, tofacitinib citrate, for the treatment of AU was described in a patient with concomitant plaque psoriasis who achieved full regrowth of hair within 8 months. Since then, the scientific understanding of AA has continued to progress, highlighting the key role that cytotoxic T lymphocytes play in AA and the potential of JAK inhibition. Due to the lack of data regarding efficacy and safety of this drug in alopecia areata we therefore aim to provide a comprehensive literature, evaluate the effectiveness, outcome and role of Tofacitinib in the treatment of AA.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2024-01-06
• Study Completion: 2024-01-16
• Study First Submitted: 2024-01-28
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients presenting with Alopecia areata as per operational definition will be included in the study.
• Either gender.
• Age 15 - 60 years.

Exclusion Criteria

• Patient with history of connective tissue disorders, vasculitis, seropositive and seronegative arthritis.
• Patients having history of treatment with systemic agents, having active infection, pregnant and lactating women and patients having severe hematological abnormalities.
• Patients positive for latent infections.
• Patients with weight <25 kg.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tofacitinib	Tofacitinib	tofacitinib 5mg twice daily for 6 months

Primary Outcome Measures

Name	Time	Method
Alopecia	6 months	To analyze the efficacy of oral Tofacitinib in moderate to severe alopecia areata, totalis and universalis at Tertiary Care Hospital, Karachi. The effect of treatment will be evaluated using photographs of the patient before and after the trial and clinical evaluation of patients. The clinical response for efficacy will be evaluated at 0, 6,12 and 24 weeks of therapy. Patient presenting with alopecia areata will be assessed for degree of improvement using SALT score on follow up after 3 months as follows: 0 (re-growth ≤10), 1 (11-25%), 2 (26-50%), 3 (51-75%) and 4 (re-growth \>75%). Efficacy will be considered if re-growth ≥3.

Trial Locations

Locations (1)

Misbah Zari Qadir; 🇵🇰 Karachi, Sindh, Pakistan