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Safety evaluation study about rituximab therapy for refractory pemphigus

Rituximab therapy for refractory pemphigus

16

Male: n = 11, Female: n = 5, Median age (years): 51 (range: 33-72)

Study treatment was administered to 16 patients for whom consent was obtained; the first patient was enrolled on May 22, 2017, and the last patient was enrolled on April 19, 2019. All 16 patients were evaluated for the primary endpoint of safety and the secondary endpoint of efficacy. After the last observation date of July 9, 2021 for the last case, data were fixed on May 26, 2022, and the results of this clinical trial were analyzed.

Adverse events (as assessed according to CTCAE v4.0) occurred in 16 of 16 patients during the entire study period. There were no known serious adverse events or treatment-related deaths. One serious adverse event (1 in 1 patient) was reported. This was pneumonia. This was a known event related to the study drug and resolved with antibiotic therapy.

Regarding the primary endpoint of study drug safety, adverse events after initiation of study drug were observed in 16 of 16 patients. There were no known serious adverse events or treatment-related deaths. There was one serious adverse event, but it was quickly resolved with treatment. One serious adverse event (one in one patient) was reported. This was pneumonia. This was a known event related to the study drug and resolved with antibiotic therapy. Regarding the secondary efficacy endpoint, 10 of the 16 patients achieved remission, with a remission rate of 62.5% [95% CI: 35.43, 84.80]. In addition, all patients showed a decrease in the clinical score of PDAI, and the steroid dose could be reduced in 13 patients.

Adverse events were observed in 16 of 16 patients, with one serious adverse event (hospitalization for pneumonia) that was known and resolved quickly with treatment. 8 Grade 3 adverse events (3 hypertension, 3 lymphocyte count decreased, 1 folliculitis, 1 central retinal vein occlusion) were observed, but no known adverse events related to the study drug were observed. There were no adverse events of Grade 4 or higher. The remission rate was 62.5% (two-sided 95% CI: 35.43, 84.8%), including patients previou

Mar. 31, 2024

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs031180405

Funakoshi Takeru

Keio University Hospital

35 Shinanomachi, Shinjuku-ku, Tokyo

takeruf@a8.keio.jp

Funakoshi Takeru

Keio University Hospital

35 Shinanomachi, Shinjuku-ku, Tokyo

+81-3-5363-3823

takeruf@a8.keio.jp

Complete

May. 08, 2017

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

1) Patient diagnosed as pemphigus and relapse disease taking corticosteroids more than PSL 10mg/day.
2) PDAI>=1
3) Greater than or equal to 20 years of age and younger than or equal to 80 years of age.
4) Able to understand and sign the Informed Consent Document.

1) Women who may possibly be pregnant or pregnant and men who plan to impregnate a woman.
2) Allergy to humanized monoclonal antibody and/or murine monoclonal antibody, murine derived component.
3) Active major medical illnesses.
4) Active infections.
5) Past history of infection within 8weeks.
6) Past history of taking antibiotics (oral ; within 2weeks, infusion ; 8weeks).
7) Past history of bacteremia within 1 year.
8) Past history of deep tissue infections and/or abscess.
9) chronic and/or recurrent infections.
10) Past history ofPatients who have or had malignancies.
11) Past history of alcoholism and/or drug intoxication.
12) Patients who have severe psychiatric disease.
13) Past history of surgical operation within 4weeks.
14) Past history of severe infection during taking immunosuppressive agent.
15) vaccinated within 28weeks.
16) Have laboratory parameters without Protocol-defined range.
17) Infused Rituximab within 24weeks.
18) Past history of Rituximab therapy more than 3times.
19) taking other investigational drugs.
20) ineffectiveness of past Rituximab therapy.

Both

Refactory Pemphigus

Infuse rituximab 1000mg/body twice biweekly.

Other disease of skin or skin tissue

088

24-week safety after Rituximab therapy (CTCAE)

Efficacy (remission rate, PDAI, antibody titer)

+81-3-5363-3503

Feb. 19, 2019

none