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

Ruijin Hospital275 enrolled

Overview

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

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

275

Conditions

Pemphigus Disease Rituximab (RTx)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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