Contributions
Abstract: EP1655
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Introduction: Rituximab, monoclonal antibody that selectively targets CD20 positive B cells, has shown significantly lower frequency of relapses and a reduction in the total number of gadolinium enhancing (Gd+) lesions relative to placebo in phase II HERMES trial for relapsing remitting multiple sclerosis (RRMS). While Rituximab itself is currently not being further developed specifically for multiple sclerosis (MS) in the setting of newer era anti-CD20 agents, its use in the clinical setting has enjoyed an upsurge in use. It has also been adapted as one of the first line agents for treatment of neuromyelitis optica spectrum disorder (NMOSD). Data supporting the long term, real world safety of Rituximab is limited as there is no risk evaluation and mitigation strategies (REMS) program to allow for thorough investigation of serious adverse events (SAEs) to this drug in MS or NMOSD patients.
Objectives: To present three cases of SAEs related to Rituximab in treatment of RRMS and NMOSD.
Aims: To contribute to the body of literature regarding the long term use of Rituximab in MS and NMOSD patients.
Methods: Comprehensive chart review of patients identified to have SAEs related to Rituximab.
Results: The first two cases were seen after 3 years of bi-yearly infusions, with 27-year-old female patient with RRMS in case 1 developing vulvovaginal pyoderma gangrenosum and 65-year-old woman in case 2 with NMOSD who developed biopsy proven eosinophilic colitis. Case 3 involves a 28-year-old woman with RRMS who developed serum sickness seven days after her initial Rituximab infusion marked by high fever, rash, and arthralgias which resolved with steroids.
Conclusions: These are rare side effects that have been described with Rituximab in rheumatological and oncological literature but have not previously be seen in patients with demyelinating disorders of central nervous system who in general use smaller doses of Rituximab without concomitant immunosuppression from other agents. Therefore, these side effects may be less known to neurologists utilizing this drug. As the anti-CD20 drugs become more popular in the current treatment era with more patients being exposed to these agents for longer period of time, it is prudent to continue to contribute to the body of literature related to side effects related to Rituximab in this population. Large scale thorough retrospective and prospective studies are needed to supplement the lack of safety data which currently exists.
Disclosure: Lana Zhovtis Ryerson has received personal compensation for participating in Speaker´s Bureau and Advisory Boards for Biogen, Teva, Celgene, and Genentech and has research support from Biogen.
Abstract: EP1655
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Introduction: Rituximab, monoclonal antibody that selectively targets CD20 positive B cells, has shown significantly lower frequency of relapses and a reduction in the total number of gadolinium enhancing (Gd+) lesions relative to placebo in phase II HERMES trial for relapsing remitting multiple sclerosis (RRMS). While Rituximab itself is currently not being further developed specifically for multiple sclerosis (MS) in the setting of newer era anti-CD20 agents, its use in the clinical setting has enjoyed an upsurge in use. It has also been adapted as one of the first line agents for treatment of neuromyelitis optica spectrum disorder (NMOSD). Data supporting the long term, real world safety of Rituximab is limited as there is no risk evaluation and mitigation strategies (REMS) program to allow for thorough investigation of serious adverse events (SAEs) to this drug in MS or NMOSD patients.
Objectives: To present three cases of SAEs related to Rituximab in treatment of RRMS and NMOSD.
Aims: To contribute to the body of literature regarding the long term use of Rituximab in MS and NMOSD patients.
Methods: Comprehensive chart review of patients identified to have SAEs related to Rituximab.
Results: The first two cases were seen after 3 years of bi-yearly infusions, with 27-year-old female patient with RRMS in case 1 developing vulvovaginal pyoderma gangrenosum and 65-year-old woman in case 2 with NMOSD who developed biopsy proven eosinophilic colitis. Case 3 involves a 28-year-old woman with RRMS who developed serum sickness seven days after her initial Rituximab infusion marked by high fever, rash, and arthralgias which resolved with steroids.
Conclusions: These are rare side effects that have been described with Rituximab in rheumatological and oncological literature but have not previously be seen in patients with demyelinating disorders of central nervous system who in general use smaller doses of Rituximab without concomitant immunosuppression from other agents. Therefore, these side effects may be less known to neurologists utilizing this drug. As the anti-CD20 drugs become more popular in the current treatment era with more patients being exposed to these agents for longer period of time, it is prudent to continue to contribute to the body of literature related to side effects related to Rituximab in this population. Large scale thorough retrospective and prospective studies are needed to supplement the lack of safety data which currently exists.
Disclosure: Lana Zhovtis Ryerson has received personal compensation for participating in Speaker´s Bureau and Advisory Boards for Biogen, Teva, Celgene, and Genentech and has research support from Biogen.