title: Adjuvant rituximab in the treatment of pemphigus vulgaris: a phase II clinical trial.
abstract: Rituximab has been tried increasingly for the treatment of pemphigus vulgaris (PV). However, there is still no consensus about its dosing regimens, efficacy, and side effects due to insufficient clinical trials. The goal of this study was to evaluate its efficacy in the treatment of PV. This is a case series of patients with PV who received rituximab, four doses of 375 mg/m(2) intravenously weekly, plus concomitant oral prednisolone. The primary outcomes were the rate of initial clinical improvement and marked clinical improvement; secondary outcomes included prednisolone doses (mg/d) at baseline, three months, six months and the last visit, as well as the side effects. Forty out of 45 patients completed the study. The mean follow-up time was 12 ± 10.69 months (range of 3-46 months). Following treatment with rituximab, all the analyzed patients with PV had initial clinical improvement after a mean period of 6.35 weeks and a marked clinical improvement after a mean of 10.13 months. The mean prednisolone dose (mg/d) decreased significantly from a baseline level of 48.75 ± 25.86 to 26.50 ± 12.95 at three months, 20.70 ± 17.51 at six months, and 15.26 ± 9.98 at the last visit (P = 0.0001). The encountered side effects following rituximab were lung abscess, sepsis, pneumonia, cavernous sinus thrombosis, skin abscess, deep vein thrombosis, generalized arthralgia, and Stevens-Johnson syndrome. According to our study, rituximab may be an effective adjuvant to prednisolone for the treatment of PV; however, its safety profile remains concerning.
authors.affiliation: Department of Dermatology, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Kamran
authors.initials: K
authors.lastname: Balighi
authors.affiliation: Department of Dermatology, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Balighi
authors.initials: B
authors.lastname: Kamran
authors.forename: Maryam
authors.initials: M
authors.lastname: Daneshpazhooh
authors.forename: Daneshpazhooh
authors.initials: D
authors.lastname: Maryam
authors.forename: Somayeh
authors.initials: S
authors.lastname: Khezri
authors.forename: Khezri
authors.initials: K
authors.lastname: Somayeh
authors.forename: Mostafa
authors.initials: M
authors.lastname: Mahdavi-nia
authors.forename: Mahdavi-nia
authors.initials: MN
authors.lastname: Mostafa
authors.forename: Mahsa
authors.initials: M
authors.lastname: Hajiseyed-javadi
authors.forename: Hajiseyed-javadi
authors.initials: HJ
authors.lastname: Mahsa
authors.forename: Cheyda
authors.initials: C
authors.lastname: Chams-Davatchi
authors.forename: Chams-Davatchi
authors.initials: CD
authors.lastname: Cheyda
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010392:Pemphigus / Q000188:drug therapy*; D011239:Prednisolone / Q000008:administration & dosage; D000069283:Rituximab; D013997:Time Factors
chemical_list: D000893:Anti-Inflammatory Agents; D058846:Antibodies, Monoclonal, Murine-Derived; D007155:Immunologic Factors; D000069283:Rituximab; D011239:Prednisolone