Contributions
Abstract: EP1657
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Background: After European Medicines Agency (EMA) approval Daclizumab (DAC) had been available in Germany for relapsing remitting Multiple sclerosis since August 2016. We started the medication in 53 patients. Due to safety concerns, we discontinued all patients in November 2017.
Objective: An evaluation of 53 patients treated with DAC concerning side effects and efficacy.
Methods: We analysed data of 53 patients (MDOC database) regarding side effects and efficacy of Daclizumab.
Results: 53 patients (10 male, 43 female) were included, mean age 39.6 years, mean EDSS 3.2.
The most and long lasting side effects were skin reactions in nine patients, in two still severely present one year after stop, recovering after Cladribine within 4 weeks. Two autoimmune hepatitis so far showed no recovery, two elevation of liver enzymes normalized. Three inflammatory bowel disease, one iritis, one tenosynovitis, three excessive lymphnode swellings occurred and a life threatening eosinophilic meningoencephalitis, proven by brain biopsy. To our knowledge at that time no similar cases had been reported. One cholangiocellular carcinoma occurred.
All patients had MS activity before start of DAC, on therapy 13 out of 15 had MRI activity and six relapsed.
Conclusion: Compared to the SELECT and DECIDE data we observed more severe side effects than expected. There was no spontaneous recovery in autoimmune hepatitis and severe skin reactions. A life threatening meningoencephalitis made us stop DAC even before the drug was withdrawn from the market. The efficacy in our patients was less than expected: 36% with disease activity on therapy.
There is an unmet need for independent registries to collect in time real life data for safety.
Disclosure: J. Haas received compensation from Biogen, Bayer, Teva, Sanofi Aventis, Allergan, Genzyme, CSL Behring, Octapharma.
S. Raunegger has nothing to disclose
Abstract: EP1657
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Background: After European Medicines Agency (EMA) approval Daclizumab (DAC) had been available in Germany for relapsing remitting Multiple sclerosis since August 2016. We started the medication in 53 patients. Due to safety concerns, we discontinued all patients in November 2017.
Objective: An evaluation of 53 patients treated with DAC concerning side effects and efficacy.
Methods: We analysed data of 53 patients (MDOC database) regarding side effects and efficacy of Daclizumab.
Results: 53 patients (10 male, 43 female) were included, mean age 39.6 years, mean EDSS 3.2.
The most and long lasting side effects were skin reactions in nine patients, in two still severely present one year after stop, recovering after Cladribine within 4 weeks. Two autoimmune hepatitis so far showed no recovery, two elevation of liver enzymes normalized. Three inflammatory bowel disease, one iritis, one tenosynovitis, three excessive lymphnode swellings occurred and a life threatening eosinophilic meningoencephalitis, proven by brain biopsy. To our knowledge at that time no similar cases had been reported. One cholangiocellular carcinoma occurred.
All patients had MS activity before start of DAC, on therapy 13 out of 15 had MRI activity and six relapsed.
Conclusion: Compared to the SELECT and DECIDE data we observed more severe side effects than expected. There was no spontaneous recovery in autoimmune hepatitis and severe skin reactions. A life threatening meningoencephalitis made us stop DAC even before the drug was withdrawn from the market. The efficacy in our patients was less than expected: 36% with disease activity on therapy.
There is an unmet need for independent registries to collect in time real life data for safety.
Disclosure: J. Haas received compensation from Biogen, Bayer, Teva, Sanofi Aventis, Allergan, Genzyme, CSL Behring, Octapharma.
S. Raunegger has nothing to disclose