A report of 10 cases of paradoxical reaction to rituximab (RTX) in patients with pemphigus is presented.Of 10 included patients (six men and four women), nine had pemphigus vulgaris, and one had pemphigus foliaceus , with the mean age of 51.9 ± 10.8 years and all patients had received RTX biosimilar (Zytux, AryoGen Pharmed, Tehran, Iran) at the dose of 2 g; post-RTX worsening interval ranged from one day to three months after the first infusion of the index cycle.Cases safely received RTX for the first time, but experienced disease exacerbation following further administration.Results show that pemphigus worsening upon administration of RTX biosimilar or original RTX is an important adverse effect to consider.In conclusion, although being extremely rare, RTX therapy may exacerbate pemphigus for unknown reasons. Increasing in prednisolone dosage and/or IVIg administration seem practical approaches to control disease after such event.

2019-11-01·Multiple Sclerosis and Related Disorders3区 · 医学

Evaluating the efficacy and safety of ZytuxTM (Rituximab, AryoGen pharmed) in Iranian multiple sclerosis patients: An observational study

3区 · 医学

Article

作者: Darki, Aala ; Hashemi, Seyedeh Nafiseh ; Ghadiri, Fereshteh ; Naser Moghadasi, Abdorreza ; Masoumi, Peiman

BACKGROUNDAnti-CD20 monoclonal antibodies such as ocrelizumab, rituximab, and ofatumumab target B-cell lineage. Clinical trials have demonstrated their effect on reducing both magnetic resonance imaging (MRI) active lesion burden as well as clinical activity. Zytux™ (Rituximab, AryoGen Pharmed) used in the present study for multiple sclerosis (MS) patients is basically a biosimilar rituximab. In this observational study, a total of 100 patients receiving Zytux™ were collected to see its effect on the clinical course of the disease.MATERIALS AND METHODSThe files of 100 MS patients, who received Zytux™ in a referral center (Sina MS Clinic in Tehran, Iran), were analyzed as a hospital-based observational study. Patients' age and disease duration until the start of Zytux™, expanded disability status scale (EDSS) at the baseline and in the last visit after administration of the drug, and annual relapse rate (ARR) before and after initiating Zytux™ were studied. Disease activity was evaluated both clinically and via MRI.RESULTA total of 100 MS patients including 36 males and 64 females participated in the present study. The patients included 20 relapsing remitting MS (RRMS), 20 primary progressive MS (PPMS), and 60 secondary progressive MS (SPMS) patients. Totally, the mean of EDSS score before and after the administration of drug was 5.50 ± 1.04 (ranging from 1 to 7) and 5.11 ± 1.59 (ranging from 0 to 7), respectively, with the difference between them being very significant (p-value: 0.000). Also, the mean of ARR before and after the initiation of the medication was 0.47 and 0.10, respectively, whose difference was also significant (p-value: 0.000). In our study, the greatest effect of Zytux™ was observed in RRMS patients. At the time of injection, 70 patients indicated some reactions including limb pain, skin sensitivity, and throat irritation. One month after the injection, one of the patients suffered from pneumonia and two patients had a urinary tract infection.CONCLUSIONThe observed results revealed that the Zytux™ could have a positive and significant effect on all types of MS.

2018-04-01·International journal of hematology-oncology and stem cell research

A Double-Blind, Randomized Comparison Study between Zytux™ vs MabThera® in Treatment of CLL with FCR Regimen: Non-Inferiority Clinical Trial.

Article

作者: Jalaeikhoo, Hassan ; Ravanbod, Mohammad Reza ; Fallahazad, Vahid ; Toogeh, Gholamreza ; Zarrabi, Fariba ; Alizadeh Fard, Shadi Sadat ; Razavi, Seyed Mohsen ; Rezaei Darzi, Ehsan ; Allahyari, Abolghasem ; Faranoush, Mohammad

BACKGROUNDChronic lymphocytic leukemia (CLL) is characterized by accumulation of B cells in blood, lymphoid tissues and bone marrow. Addition of rituximab to CLL chemotherapy regimens has been associated with improved survival. The aim of this study was to establish efficacy and safety of Zytux™ in comparison to MabThera^® in treatment of CLL.MATERIALS AND METHODSSeventy CLL patients who met the criteria for entering the study were randomized into two groups (35 patients in each group). Both groups received Fludarabine and Cyclophosphamide plus Rituximab as part of the FCR regimen. Group A was treated with Zytux™, and group B was treated with MabThera^®. A non-inferiority margin of 20% for the primary outcome was defined to examine the similarity between Zytux™ and MabThera^®.RESULTSBaseline demographic characteristics showed no statistically signiﬁcant difference between the two groups. The two treatment groups were comparable in terms of laboratory and clinical findings, cellular index changes and CD (5, 19, 20 and 23) counts during therapy cycles and at the end of the treatment period. Regarding safety results, Zytux™ demonstrated a similar profile of adverse reactions in comparison to MabThera^®. Moreover, the overall response rate was 88% and 89% for Zytux™ and MabThera^®, respectively (CI -0.17, 0.18).CONCLUSIONResults showed non-inferiority of Zytux™ in terms of efficacy and adverse events as a biosimilar version of MabThera^®.

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