Skip to main content
OpenTrials
Completed

NCT Number: NCT06561256

JAK Inhibitors' Efficacy in Bullous Pemphigoid

Bullous pemphigoid (BP) is an autoimmune subepidermal blistering skin disease that predominantly affects the elderly population, with rare cases reported in children and adolescents. BP is characterized by circulating antibodies that target the hemidesmosomal proteins bullous pemphigoid Antigen 1 (BPAg1 or BP230) and bullous pemphigoid Antigen 2 (BPAg2 or BP180/collagen XVII) located at the dermal-epidermal junction. The first-line treatment of BP includes topical or systemic use of corticosteroids. For refractory cases or when corticosteroids are contraindicated or to minimize adverse effects, adjunct therapies such as immunosuppressants (e.g. azathioprine, cyclosporine), dapsone, tetracycline antibiotics combined with niacinamide, intravenous immunoglobulins (IVIG), and plasma exchange are employed. Recent research has explored the use of biologic agents to treat refractory BP, including anti-CD20 monoclonal antibodies, anti-IgE monoclonal antibodies, and anti-interleukin monoclonal antibodies, showing promising outcomes. Nevertheless, effectively managing BP remains a challenge.

The Janus kinase (JAK)-signal transducer and activator of transcription (STAT) pathway has been implicated as a key driver in many inflammatory diseases. Recently, a class of drugs targeting this pathway, known as JAK inhibitors, has been developed. Some studies have investigated the efficacy and safety of JAK inhibitors combination with corticosteroids in BP treatment. In this retrospective study, the investigators conducted a comparative analysis to evaluate the efficacy and safety of JAK inhibitors combination With corticosteroids for patients diagnosed with moderate-to-severe bullous pemphigoid.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bullous Pemphigoid Autoimmune Diseases Corticosteroids Immune System Diseases Janus Kinase Inhibitor Pemphigoid, Bullous Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Fujian Medical University

Fujian, Fuzhou, 350000, China

About this study

This study will conduct a retrospective review of patients with Bullous pemphigoid in the Department of Dermatology of the First Affiliated Hospital of Fujian Medical University. Researchers will initially screen patients based on the inclusion and exclusion criteria through their respective hospital's medical record systems at the beginning of the study. All enrolled patients will be followed for a duration of 48 weeks. This study will include approximately 300 patients with moderate to severe BP.

The Primary outcomes were the time to cease of new lesions, time to achieve minimal therapy, the cumulative amount of corticosteroids (at the time of achieving minimal therapy). The Secondary outcomes were the scores of BPDAI (week 0, week 2, and week 4). the scores of itching Numeric Rating Scale (NRS) (week 0, week 2, and week 4). the level of IgE (week 0, week 2) and eosinophil percentage (Eos%) (week 0, week 2). the clinical remissions at week 24 and week 48. Adverse events: all treatment-related adverse events (AEs) were assessed.

The statistical analysis was performed using GraphPad Prism software 10.0 and SPSS 29.0. Categorical variables were presented as frequencies and percentages. Continuous variables were represented as means and standard deviations (SD) or as medians and interquartile ranges (IQR). Absolute and relative frequencies were used to describe qualitative variables. Groups were compared using chi-square test for qualitative variables and independent sample t-test or analysis of variance (ANOVA) for quantitative variables with symmetric distribution. The Mann-Whitney U test or Kruskal-Wallis test were used for quantitative variables with skewed distributions. P< 0.05 was considered statistically significant.

Upon completion, the study will analyze the collected data and to assess the efficacy and safety of the combination of Janus kinase inhibitors and corticosteroids in treatment of BP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Bullous pemphigoid;
  • Moderate to severe bullous pemphigoid； The disease severity was measured using the Bullous Pemphigoid Disease Area Index (BPDAI) score and was classified into mild (BPDAI ≤ 19), moderate (20 ≤ BPDAI ≤ 56), and severe (BPDAI ≥ 57).
  • Moderate to severe BP received JAK Inhibitors combination with corticosteroids therapy；

Exclusion criteria

  • Patients diagnosed with malignant neoplasms
  • Previous administration with biologics within 3 months

Treatment and study plan

Janus Kinase Inhibitor

Drug

Janus Kinase Inhibitor in combination with corticosteroids

Primary outcomes

  1. Time to cease of new lesions

    Time frame: 2022.01.01-2024.07.31

    The time from baseline to cease of new blister formation.

  2. Time to achieve minimal therapy.

    Time frame: 2022.01.01-2024.07.31

    Minimal therapy defined as ≤ 0.1 mg/kg/d of prednisone (or equivalent) or 20 g/wk of clobetasol propionate and/or minimal adjuvant or maintenance therapy

  3. The cumulative amount of methylprednisolone (at the time of achieving minimal therapy).

    Time frame: 2022.01.01-2024.07.31

    The cumulative amount of methylprednisolone from baseline to the time of achieving minimal therapy

Secondary outcomes

  1. The scores of BPDAI

    Time frame: 2022.01.01-2024.07.31

    the Bullous Pemphigoid Disease Area Index (BPDAI) scores and was classified into mild (BPDAI ≤ 19), moderate (20 ≤ BPDAI ≤ 56), and severe (BPDAI ≥ 57). This study included patients with moderate to severe BP.

  2. The scores of itching Numeric Rating Scale (NRS)

    Time frame: 2022.01.01-2024.07.31

    The patient is asked to rate their current level of itching on this 0-10 scale. 0 - No itching 1-3 - Mild itching 4-6 - Moderate itching 7-10 - Severe itching. This NRS score for itching can help healthcare providers assess the severity of the patient's itching, track changes over time, and guide appropriate treatment interventions.

  3. Adverse events

    Time frame: 2022.01.01-2024.07.31

    All treatment-related adverse events (AEs) were assessed.

  4. Clinical remissions

    Time frame: 2022.01.01-2024.07.31

    Partial remission on minimal therapy: presence of transient new lesions that heal within 1 week while patient is receiving minimal therapy for at least 2 months Complete remission on minimal therapy: absence of new or established lesions or pruritus while patient is receiving minimal therapy for at least 2 months Partial remission off therapy: presence of transient new lesions that heal within 1 week without treatment while patient is off all BP therapy for at least 2 months.

    Complete remission off therapy: absence of new or established lesions or pruritus while patient is off all BP therapy for at least 2 months.

Sponsors and collaborators

Lead sponsor

Chao Ji

Other

Registry information

Official study title

Effectiveness and Safety of Combination Therapy With Corticosteroids and JAK Inhibitors in Bullous Pemphigoid

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.