Abstract: EP1748
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Introduction: Alemtuzumab is a monoclonal antibody used as induction or escalation therapy in patients with multiple sclerosis (MS). The most frequent adverse events happened in the first months.
Objective: To study the adverse events in the first months of treatment with alemtuzumab in MS patients in real world.
Methods: Observational study. We study patients with multiple sclerosis, who received at least one cycle of alemtuzumab and were followed at least six months. Blood and urin tests were performed at baseline, three and five days after the start and later monthly.
Results: 20 patients with RRMS (16 females, mean age 43 ) with and baseline EDSS of 5.5 ( 2.5-7.0) were studied.
The most frequent adverse event during the infusions was mild to moderate rash. Interestingly, in 80 % of the patients there was a transitory increase of liver enzymes (between 2- and 5-fold the upper limit of normal, ALT maximum 196 u/l) between the third and the fifth day of the infusion in 80 % of the patients. One patient with 10 times elevation of ALT and AST presented an acute abdominal pain, the treatment was discontinued and the liver enzymes were normalized after two weeks. Hepatitis C and B were discarded. Other adverse events in the first week were fever (40%), headache (35%), fatigue (10%).
During the first month three patients suffered from unfrequent infections produced by Lysteria monocytogenes, by blastocystis hominis and by herpes zoster. After the adequate treatment were solved without sequelae.
Conclusions: Most frequent adverse events with alemtuzumab were cutaneous rash and liver enzymes elevation in the first week. Some not common infections appeared in the first month. Monitoring of infections in the first month is needed. Vaccinations or antibiotics could be useful in some patients to reduce the number and severity of infections.
Disclosure: Celia Oreja-Guevara has received honoraria for speaking and/or consultancy from Biogen, Genzyme, Bayer, Merck, Roche, Teva and Novartis
Abstract: EP1748
Type: ePoster
Abstract Category: Therapy - disease modifying - 29 Risk management for disease modifying treatments
Introduction: Alemtuzumab is a monoclonal antibody used as induction or escalation therapy in patients with multiple sclerosis (MS). The most frequent adverse events happened in the first months.
Objective: To study the adverse events in the first months of treatment with alemtuzumab in MS patients in real world.
Methods: Observational study. We study patients with multiple sclerosis, who received at least one cycle of alemtuzumab and were followed at least six months. Blood and urin tests were performed at baseline, three and five days after the start and later monthly.
Results: 20 patients with RRMS (16 females, mean age 43 ) with and baseline EDSS of 5.5 ( 2.5-7.0) were studied.
The most frequent adverse event during the infusions was mild to moderate rash. Interestingly, in 80 % of the patients there was a transitory increase of liver enzymes (between 2- and 5-fold the upper limit of normal, ALT maximum 196 u/l) between the third and the fifth day of the infusion in 80 % of the patients. One patient with 10 times elevation of ALT and AST presented an acute abdominal pain, the treatment was discontinued and the liver enzymes were normalized after two weeks. Hepatitis C and B were discarded. Other adverse events in the first week were fever (40%), headache (35%), fatigue (10%).
During the first month three patients suffered from unfrequent infections produced by Lysteria monocytogenes, by blastocystis hominis and by herpes zoster. After the adequate treatment were solved without sequelae.
Conclusions: Most frequent adverse events with alemtuzumab were cutaneous rash and liver enzymes elevation in the first week. Some not common infections appeared in the first month. Monitoring of infections in the first month is needed. Vaccinations or antibiotics could be useful in some patients to reduce the number and severity of infections.
Disclosure: Celia Oreja-Guevara has received honoraria for speaking and/or consultancy from Biogen, Genzyme, Bayer, Merck, Roche, Teva and Novartis