Efficacy and Safety of Different Doses of Rituximab Therapy in Pemphigus Patients

Efficacy and Safety of Different Doses of Rituximab Therapy in Pemphigus Patients--a Multicenter Retrospective Study

Investigating the clinical efficacy of different doses of rituximab in patients with pemphigus

Study Overview

• Status: Completed
• Conditions: Rituximab (RTx); Pemphigus Disease

Detailed Description

Pemphigus is a severe autoimmune skin disease traditionally treated with systemic corticosteroids and immunosuppressants. Recent studies have highlighted the superior efficacy of rituximab combined with systemic corticosteroids, establishing this combination as a first-line treatment for pemphigus patients.

Currently, the administration protocols for rituximab in pemphigus patients often refer to the dosage used for rheumatoid arthritis: two intravenous infusions of 500 mg or 1000 mg spaced two weeks apart, with an additional 500 mg infusion after 6 to 9 months if necessary. Recently, several studies have reported successful treatment of pemphigus using low-dose (single 500 mg dose) or ultra-low-dose (single 200 mg dose) rituximab.

As an optimal dosage regimen for pemphigus has yet to be established, we conducted a retrospective cohort study to evaluate the efficacy of different rituximab dosages and explore the optimal dosing strategy for the treatment of pemphigus.

• Study Type: Observational
• Enrollment (Actual): 275

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Department of Dermatology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients who had a clinical presentation of active pemphigus combined with immunological or pathological evidence, and received rituximab

Description

Inclusion Criteria:

1. patients with a diagnosis of pemphigus vulgaris or foliaceus in active stage based on guideline indicators, including typical clinical presentation, positive direct immunofluorescence microscopy findings, and/or detection of serum anti-Dsg3 and/or Dsg1 immunoglobin (Ig)G autoantibodies
2. follow-up for at least 6 months after initiation of rituximab therapy

Exclusion Criteria:

1. Previous use of rituximab for other indications
2. concomitant use of other biological agents within 6 months (e.g. Dupilumab,IL-17,FcRn)
3. with a diagnosis of other variants of pemphigus besides PV and PF

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group A; one dose of 500mg RTX
Group B; two doses of 500mg RTX
Group C; two doses of 1000mg RTX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relapse	according to Pemphigus S2 Guideline，patient who has achieved disease control appears ≥3 new lesions/month that do not heal spontaneously within 1 week, or patient's established lesions extend	week 4, 8, 12, 24, 36, 48 after treatment
disease control	according to Pemphigus S2 Guideline, patients' new lesions cease to form and established lesions begin to heal	week 4, 8, 12, 24, 36, 48 after treatment
adverse evert		week 4, 8, 12, 24, 36, 48 after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peripheral CD19+ cell counts		week 4, 8, 12, 24, 36, 48 after treatment
immunoglobulin levels		week 4, 8, 12, 24, 36, 48 after treatment
serum anti-Dsg1 and Dsg3 autoantibody levels		week 4, 8, 12, 24, 36, 48 after treatment
dose of glucocorticoids	According to the clinical glucocorticoid dosage record	week 4, 8, 12, 24, 36, 48 after treatment
Concomitant medication	According to the clinical medication record	week 4, 8, 12, 24, 36, 48 after treatment

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: Peking University First Hospital; West China Hospital; Second Xiangya Hospital of Central South University; Chinese Academy of Medical Sciences; Guangdong Provincial Dermatology Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: March 3, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Rituximab; Adverse effect; Pemphigus
• Additional Relevant MeSH Terms: Autoimmune Diseases; Immune System Diseases; Skin Diseases; Skin Diseases, Vesiculobullous; Skin and Connective Tissue Diseases; Pemphigus
• Other Study ID Numbers: MR-31-25-090840