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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07457944

Enrollment

275

Registered

2026-03-09

Start date

2019-01-01

Completion date

2026-01-01

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pemphigus Disease, Rituximab (RTx)

Keywords

Pemphigus, Rituximab, Adverse effect

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame	Description
relapse	week 4, 8, 12, 24, 36, 48 after treatment	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
disease control	week 4, 8, 12, 24, 36, 48 after treatment	according to Pemphigus S2 Guideline, patients' new lesions cease to form and established lesions begin to heal
adverse evert	week 4, 8, 12, 24, 36, 48 after treatment	—

Secondary

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

Countries

China

Outcome results