PMID- 31074302
OWN - NLM
STAT- MEDLINE
DCOM- 20201229
LR  - 20201229
IS  - 1471-1753 (Electronic)
IS  - 0954-6634 (Linking)
VI  - 32
IP  - 1
DP  - 2021 Feb
TI  - Efficacy and safety of biosimilar rituximab in patients with pemphigus vulgaris: 
      a prospective observational study.
PG  - 33-40
LID - 10.1080/09546634.2019.1617831 [doi]
AB  - Background: The optimal treatment for pemphigus vulgaris (PV) has not been 
      clearly determined yet. Rituximab (RTX) was recently approved for the management 
      of adults with moderate to severe PV. Objectives: This prospective observational 
      study was designed to evaluate the efficacy and safety of biosimilar RTX in PV 
      patients.Methods: The efficacy and safety were evaluated by assessing the 
      pemphigus disease area index (PDAI) score, clinical response and any adverse 
      events (AEs) during at least 12-month follow-up. We evaluated anti-desmoglein 
      (Dsg) 1,3 level at baseline, 3 months and 12 months after RTX infusion.Results: A 
      total of 110 patients treated with biosimilar RTX were enrolled between May 2016 
      and July 2017. The mean age was 43.58 +/- 11.77 years and the mean follow-up time 
      was 16.22 +/- 3.45 months. A notable decrease in PDAI score, anti-Dsg 1,3 level and 
      prednisolone dosage was observed. Median delay to achieve complete remission 
      (CR), median duration of CR, and median time to relapse were 3, 9, and 12 months, 
      respectively. Newly diagnosed patients (NDPs) experienced higher rate of CR, 
      longer duration of remission and lower risk of relapse, compared to previously 
      treated patients (PTPs). A total of 47 AEs were observed in 33 (30%) patients, 
      which were mostly mild infusion-related reactions.Conclusion: Administration of 
      biosimilar RTX in PV patients was associated with desirable outcomes in terms of 
      efficacy and safety in both NDPs and PTPs.First-line use of RTX in NDPs was more 
      effective and allowed a rapid tapering of corticosteroid doses compared to PTPs.
FAU - Toosi, Roja
AU  - Toosi R
AD  - Department of Dermatology, Autoimmune Bullous Diseases Research Center, Tehran 
      University of Medical Sciences, Tehran, Iran.
FAU - Mahmoudi, Hamidreza
AU  - Mahmoudi H
AUID- ORCID: 0000-0002-1890-1005
AD  - Department of Dermatology, Autoimmune Bullous Diseases Research Center, Tehran 
      University of Medical Sciences, Tehran, Iran.
FAU - Balighi, Kamran
AU  - Balighi K
AD  - Department of Dermatology, Autoimmune Bullous Diseases Research Center, Tehran 
      University of Medical Sciences, Tehran, Iran.
FAU - Teimourpour, Amir
AU  - Teimourpour A
AD  - Department of Dermatology, Autoimmune Bullous Diseases Research Center, Tehran 
      University of Medical Sciences, Tehran, Iran.
AD  - Department of Epidemiology and Biostatistics, School of Public Health, Tehran 
      University of Medical Sciences, Tehran, Iran.
FAU - Alaeen, Hoorieh
AU  - Alaeen H
AD  - Department of Dermatology, Autoimmune Bullous Diseases Research Center, Tehran 
      University of Medical Sciences, Tehran, Iran.
FAU - Shaghaghi, Mohammadreza
AU  - Shaghaghi M
AD  - Russell H. Morgan Department of Radiology and Radiological Sciences, Johns 
      Hopkins Hospital, Baltimore, MD, USA.
FAU - Abedini, Robabeh
AU  - Abedini R
AD  - Department of Dermatology, Autoimmune Bullous Diseases Research Center, Tehran 
      University of Medical Sciences, Tehran, Iran.
FAU - Daneshpazhooh, Maryam
AU  - Daneshpazhooh M
AUID- ORCID: 0000-0003-1020-8895
AD  - Department of Dermatology, Autoimmune Bullous Diseases Research Center, Tehran 
      University of Medical Sciences, Tehran, Iran.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20190528
PL  - England
TA  - J Dermatolog Treat
JT  - The Journal of dermatological treatment
JID - 8918133
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - 0 (Biosimilar Pharmaceuticals)
RN  - 4F4X42SYQ6 (Rituximab)
RN  - 9PHQ9Y1OLM (Prednisolone)
SB  - IM
MH  - Adult
MH  - Antineoplastic Agents, Immunological/adverse effects/*therapeutic use
MH  - Biosimilar Pharmaceuticals/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Pemphigus/*drug therapy/mortality
MH  - Prednisolone/therapeutic use
MH  - Prospective Studies
MH  - Recurrence
MH  - Remission Induction
MH  - Rituximab/adverse effects/therapeutic use
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Pemphigus vulgaris
OT  - biosimilar
OT  - efficacy
OT  - pemphigus disease area index
OT  - rituximab
OT  - safety
EDAT- 2019/05/11 06:00
MHDA- 2020/12/30 06:00
CRDT- 2019/05/11 06:00
PHST- 2019/05/11 06:00 [pubmed]
PHST- 2020/12/30 06:00 [medline]
PHST- 2019/05/11 06:00 [entrez]
AID - 10.1080/09546634.2019.1617831 [doi]
PST - ppublish
SO  - J Dermatolog Treat. 2021 Feb;32(1):33-40. doi: 10.1080/09546634.2019.1617831. 
      Epub 2019 May 28.