Efficacy and safety of biosimilar rituximab in patients with pemphigus vulgaris: a prospective observational study

Toosi, Roja; Mahmoudi, Hamidreza; Balighi, Kamran; Teimourpour, Amir; Alaeen, Hoorieh; Shaghaghi, Mohammadreza; Abedini, Robabeh; Daneshpazhooh, Maryam

doi:10.1080/09546634.2019.1617831

Cited by 27 publications

(35 citation statements)

References 39 publications

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“…The findings of the previous studies support the efficacious role of RTX in the improvement of PV 10‐12 . Joly et al 13 suggested RTX in combination with prednisone as a more effective and lower‐risk medication compared to prednisone alone for the first‐line therapy in patients with PV.…”

Section: Introductionmentioning

confidence: 69%

“…9 The findings of the previous studies support the efficacious role of RTX in the improvement of PV. [10][11][12] Joly et al 13 suggested RTX in combination with prednisone as a more effective and lower-risk medication compared to prednisone alone for the first-line therapy in patients with PV. Considering the risk of severe side effects of RTX such as anaphylactic reactions and opportunistic infections 9 as well as its high cost, 14 some researchers have been interested in using lowdose intralesional injections of RTX in some patients with B-cell lymphomas 15 or PV.…”

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confidence: 99%

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Intralesional injection of biosimilar rituximab in recalcitrant mucocutaneous lesions of patients with pemphigus vulgaris: A pilot study

Mazloom

Daneshpazhooh

Shoormasti

et al. 2020

Dermatologic Therapy

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The efficacy of intravenous rituximab (RTX) in patients with pemphigus have been shown in the previous studies. The study aimed to investigate the effectiveness of intralesional injection of RTX in the healing of pemphigus lesions, with lower doses and probable better safety profile than intravenous RTX. Eleven Pemphigus patients with recalcitrant lesions received two intralesional injections of biosimilar RTX, 5 mg/cm 2. During 6 months follow-up, Pemphigus Disease Area Index, the patients' satisfaction, quality of life, the disease activity, the number and size of lesions, the anti-desmoglein (Dsg) 1 and 3 antibodies and the count of CD4+ and CD19+ cells were assessed. All patients were in partial remission on therapy. The absolute count of CD19+ B cells showed a statistically significant decline (P = .006). The percentage of CD4 + T lymphocytes increased 2 weeks after injection and decreased 2 weeks later (P = .01). The average number and size of lesions decreased. The concentration of anti-Dsg 3 antibody decreased insignificantly during the study. The severe pain during the injection was considered as the main complication. At the end of the study, two patients were in complete remission on therapy, and the other nine remained in partial remission on therapy. Few side effects resulting from intralesional injection of RTX and enhanced quality of life of the patients were considered as the valuable achievements of this study. The results showed that although a low dose of RTX leads to a significant decrease of CD19+ B lymphocytes, it did not show parallel clinical effectiveness.

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Section: Introductionmentioning

confidence: 69%

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confidence: 99%

Intralesional injection of biosimilar rituximab in recalcitrant mucocutaneous lesions of patients with pemphigus vulgaris: A pilot study

Mazloom

Daneshpazhooh

Shoormasti

et al. 2020

Dermatologic Therapy

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“…There are few studies regarding rituximab side effects on Iranian patients. In one study, the effects of rituximab in pemphigus was reported (14). Furthermore, Seyed Ahadi et al and Shaygannejad et al evaluated the efficacy and safety of rituximab in patients with NMO.…”

Section: Comparison Of Other Results Conducted On Iranian Populationmentioning

confidence: 99%

Infusion-Related, Short-term, and Delayed Side Effects of Rituximab in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder

2020

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Background: Rituximab is a monoclonal antibody against CD20 antigen present on mature B lymphocytes. It is commonly used in some hematologic, rheumatologic as well as neurologic disorders, including multiple sclerosis (MS) and neuromyelitis optica (NMO). Although there are some data about the safety of rituximab in patients with MS and NMO, there are few experiences regarding its safety in the Iranian population with MS, and known complications are often related to the studies conducted on the patients in other countries or with other autoimmune diseases and malignancies that are different from the population of patients with MS in terms of the underlying disease status and the concomitant medications or previous medications used. Objectives: The aim of this study was to investigate the short-term and delayed side effects of rituximab on patients with MS and NMO in the population of the south of Iran. Methods: This was a longitudinal study on patients with MS and neuromyelitis optica who were referred to the health centers affiliated to Shiraz University of Medical Sciences from September 2018 to February 2019 and received Rituximab. They were observed for side effects from the first infusion of the drug to at least 6 months later. A checklist prepared by the researcher was used to collect the data. Independent t-test and chi-square test were used for data analysis. The significance level was considered 0.05 in this study. Results: In this study, 37% of the patients had at least one side effect during the first infusion. The most common side effect was chills (shivering). Short-term side effects occurred in 15.5% of the patients. The most common type was skin manifestations. These side effects led to hospitalization in two patients. Delayed side effect was developed in 20.7% of the patients. The most common delayed side effect was skin manifestations. Conclusions: Overall, there was no unexpected side effect in patients under the study and the side effects developed were comparable to previous studies as well as those conducted on patients other than patients with MS and neuromyelitis optica. Side effects were often mild, with only two cases leading to hospitalization, both of which were self-limiting as well, and there were no serious life-threatening side effects, except for one case with bradycardia.

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“…The decline will allow us to assess whether the remissions will be extended. All cases demonstrated significant improvement or complete remission and most experienced no adverse events [4][5][6][7][8] Rituximab appears to be both well tolerated and efficacious for refractory juvenile pemphigus foliaceus [6]. Therefore, it may be considered for severe cases of PF to avoid side effects associated with conventional glucocorticoid therapy [5,[7][8][9][10].…”

Section: Discussionmentioning

confidence: 98%

Efficacy of Rituximab in the treatment of pemphigus: experience of Moroccan population

Bay¹,

Senhaji²,

Elloudi³

2019

Our Dermatol Online

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Background: Pemphigus is a severe autoimmune blistering disease mediated by pathogenic anti-desmoglein antibodies leading to an inter keratinocyte disjunction. Rituximab is a monoclonal antibody that binds to the CD-20 antigen of B lymphocytes, which causes B-cell depletion and a subsequent reduction in pathogenic autoantibodies. Its therapeutic role in vulgaris and superficial pemphigus has been progressively growing with increasing evidence of successful outcomes. Material and Methods: It was a prospective study extending for two years in the dermatology department of the UHC Hassan II in Fez, dealing with patients with pemphigus who are severe or resistant to conventional treatments treated with Rituximab. We analyzed the efficacy and tolerance of Rituximab in the treatment of severe and refractory forms of our pemphigus population. Results: Patients treated by Rituximab were 13. Eleven cases of pemphigus vulgaris and two cases of superficial pemphigus In our series, Rituximab was used with satisfactory, indeed, 6 patients achieved complete remission, while 4 had partial remission. Side effects of Rituximab were infectious complications. Conclusions: We highlight the efficiency and safety of Rituximab in our series.

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Efficacy and safety of biosimilar rituximab in patients with pemphigus vulgaris: a prospective observational study

Cited by 27 publications

References 39 publications

Intralesional injection of biosimilar rituximab in recalcitrant mucocutaneous lesions of patients with pemphigus vulgaris: A pilot study

Intralesional injection of biosimilar rituximab in recalcitrant mucocutaneous lesions of patients with pemphigus vulgaris: A pilot study

Infusion-Related, Short-term, and Delayed Side Effects of Rituximab in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder

Efficacy of Rituximab in the treatment of pemphigus: experience of Moroccan population

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