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Efficacy and safety of biosimilar rituximab in patients with pemphigus vulgaris: a prospective observational study.
J Dermatolog Treat. 2021 Feb; 32(1):33-40.JD

Abstract

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.

Authors+Show Affiliations

Department of Dermatology, Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.Department of Dermatology, Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.Department of Dermatology, Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.Department of Dermatology, Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran. Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.Department of Dermatology, Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins Hospital, Baltimore, MD, USA.Department of Dermatology, Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.Department of Dermatology, Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.

Pub Type(s)

Journal Article
Observational Study

Language

eng

PubMed ID

31074302

Citation

Toosi, Roja, et al. "Efficacy and Safety of Biosimilar Rituximab in Patients With Pemphigus Vulgaris: a Prospective Observational Study." The Journal of Dermatological Treatment, vol. 32, no. 1, 2021, pp. 33-40.
Toosi R, Mahmoudi H, Balighi K, et al. Efficacy and safety of biosimilar rituximab in patients with pemphigus vulgaris: a prospective observational study. J Dermatolog Treat. 2021;32(1):33-40.
Toosi, R., Mahmoudi, H., Balighi, K., Teimourpour, A., Alaeen, H., Shaghaghi, M., Abedini, R., & Daneshpazhooh, M. (2021). Efficacy and safety of biosimilar rituximab in patients with pemphigus vulgaris: a prospective observational study. The Journal of Dermatological Treatment, 32(1), 33-40. https://doi.org/10.1080/09546634.2019.1617831
Toosi R, et al. Efficacy and Safety of Biosimilar Rituximab in Patients With Pemphigus Vulgaris: a Prospective Observational Study. J Dermatolog Treat. 2021;32(1):33-40. PubMed PMID: 31074302.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of biosimilar rituximab in patients with pemphigus vulgaris: a prospective observational study. AU - Toosi,Roja, AU - Mahmoudi,Hamidreza, AU - Balighi,Kamran, AU - Teimourpour,Amir, AU - Alaeen,Hoorieh, AU - Shaghaghi,Mohammadreza, AU - Abedini,Robabeh, AU - Daneshpazhooh,Maryam, Y1 - 2019/05/28/ PY - 2019/5/11/pubmed PY - 2020/12/30/medline PY - 2019/5/11/entrez KW - Pemphigus vulgaris KW - biosimilar KW - efficacy KW - pemphigus disease area index KW - rituximab KW - safety SP - 33 EP - 40 JF - The Journal of dermatological treatment JO - J Dermatolog Treat VL - 32 IS - 1 N2 - 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. SN - 1471-1753 UR - https://www.unboundmedicine.com/medline/citation/31074302/Efficacy_and_safety_of_biosimilar_rituximab_in_patients_with_pemphigus_vulgaris:_a_prospective_observational_study_ L2 - https://www.tandfonline.com/doi/full/10.1080/09546634.2019.1617831 DB - PRIME DP - Unbound Medicine ER -