Contributions
Abstract: P1649
Type: LB Poster
Abstract Category: Late Breaking News
Background: Rituximab is an old drug, originally developed for treatment of B cell lymphoma and rheumatoid arthritis. In Sweden, this B cell depleting agent has got widespread off-label use for multiple sclerosis (MS), initially as a treatment in cases of treatment failure with conventional immunomodulating drugs (DMD). With time, use has expanded to include de novo patients in some parts of Sweden. July 1st 2016, more than 2500 MS patients were treated with rituximab, constituting 27 % of all DMD treated patients in Sweden, making it the most frequently used drug. There are only a few controlled studies on rituximab use in MS, but many clinicians consider it to be safe. At Uppsala University Hospital two cases with suspected serious adverse events occurred in spring 2016, which resulted in a systematic search for adverse events.
Method: After two cases of rituximab-treated MS patients with possible severe side effects were found, all MS patients were scrutinized for side effects, using the medical files and the Swedish national MS patient register (SMSreg).
Forty (21 women, 19 men) MS patients from the county of Uppsala, were treated with rituximab, in all 14 % of the treated patients according to SMSreg [n=278). One additional case (male) with the diagnosis myelitis and possible side effects was also found and added to the analysis. This register has an estimated coverage of about 75 %, containing detailed clinical data on more than 17500 MS patients on the national level. In the county of Uppsala, Sweden there are 693 patients in the SMSreg (population 355 000 inhabitants).
Results: The two index cases consisted of one patient with hepatic failure and one patient with ruptured diverticulitis and peritonitis connected with a small malignant colon tumour. After the survey, the following possible side effects could be identified: one case of anal malignant tumour, one case of psoriasis, one case of herpes keratitis (myelitis diagnosis), four cases of repeated or chronic respiratory infections and one case with probable increased fatigue. Three patients were reported regarding side effects to the Medical Pharmaceutical Agency
Conclusion: A causal connection between these adverse events and rituximab use cannot be proven. However, the large proportion of patients with adverse events (25 %) is noteworthy. With off label use of potent DMDs, like presently in Sweden, it should be mandatory to monitor possible side effects, especially in the long term.
Disclosure:
Joachim Burman
Has received travel support and/or lecture honoraria from Almirall, Biogen, Genzyme a Sanofi Company, Hospira and Merck Serono; has received unconditional research grants from Biogen and Merck Serono.
Anne-Marie Landtblom
Has received lecture honoraria and/or research grants from Biogen, Genzyme, Sanofi, Merck Serono, Teva.
Inger Boström
No conflict of interest
Abstract: P1649
Type: LB Poster
Abstract Category: Late Breaking News
Background: Rituximab is an old drug, originally developed for treatment of B cell lymphoma and rheumatoid arthritis. In Sweden, this B cell depleting agent has got widespread off-label use for multiple sclerosis (MS), initially as a treatment in cases of treatment failure with conventional immunomodulating drugs (DMD). With time, use has expanded to include de novo patients in some parts of Sweden. July 1st 2016, more than 2500 MS patients were treated with rituximab, constituting 27 % of all DMD treated patients in Sweden, making it the most frequently used drug. There are only a few controlled studies on rituximab use in MS, but many clinicians consider it to be safe. At Uppsala University Hospital two cases with suspected serious adverse events occurred in spring 2016, which resulted in a systematic search for adverse events.
Method: After two cases of rituximab-treated MS patients with possible severe side effects were found, all MS patients were scrutinized for side effects, using the medical files and the Swedish national MS patient register (SMSreg).
Forty (21 women, 19 men) MS patients from the county of Uppsala, were treated with rituximab, in all 14 % of the treated patients according to SMSreg [n=278). One additional case (male) with the diagnosis myelitis and possible side effects was also found and added to the analysis. This register has an estimated coverage of about 75 %, containing detailed clinical data on more than 17500 MS patients on the national level. In the county of Uppsala, Sweden there are 693 patients in the SMSreg (population 355 000 inhabitants).
Results: The two index cases consisted of one patient with hepatic failure and one patient with ruptured diverticulitis and peritonitis connected with a small malignant colon tumour. After the survey, the following possible side effects could be identified: one case of anal malignant tumour, one case of psoriasis, one case of herpes keratitis (myelitis diagnosis), four cases of repeated or chronic respiratory infections and one case with probable increased fatigue. Three patients were reported regarding side effects to the Medical Pharmaceutical Agency
Conclusion: A causal connection between these adverse events and rituximab use cannot be proven. However, the large proportion of patients with adverse events (25 %) is noteworthy. With off label use of potent DMDs, like presently in Sweden, it should be mandatory to monitor possible side effects, especially in the long term.
Disclosure:
Joachim Burman
Has received travel support and/or lecture honoraria from Almirall, Biogen, Genzyme a Sanofi Company, Hospira and Merck Serono; has received unconditional research grants from Biogen and Merck Serono.
Anne-Marie Landtblom
Has received lecture honoraria and/or research grants from Biogen, Genzyme, Sanofi, Merck Serono, Teva.
Inger Boström
No conflict of interest