Contributions
Abstract: EP1671
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Ocrelizumab is a disease-modifying therapy (DMT) belonging to the family of anti-CD20 monoclonal antibodies. This drug targets B cells expressing the CD20 receptor and has been recently approved for the treatment of primary progressive (PP) and relapsing (R) multiple sclerosis (MS). Risk of infections is increased during ocrelizumab treatment. Although Hepatitis B virus (HBV) reactivation is considered a possible event because of the evidences coming from similar DMT targeting B cells, no cases of HBV reactivation have been reported for ocrelizumab, so far. Here we describe the first case of HBV reactivation in a patient under ocrelizumab treatment. A 60-year-old Caucasian male affected by PPMS since 2012, with an expanded disability status scale of 6.5 and previously treated with azathioprine, was started on ocrelizumab in February 2018, receiving two administrations of the drug (15 days apart). Pre-ocrelizumab serologic tests showed the presence of antibodies against HBV surface and core antigens (HBsAb and HBcAb, respectively), while HBV surface and e antigens (HBsAb and HBeAg, respectively) and antibodies against HBV e antigen (HBeAb) were negative. Furthermore, pre-ocrelizumab HBV-DNA was undetectable (< 20 IU/ml) and liver enzymes were within normal ranges. Considering the status of HBV inactive carrier, ocrelizumab treatment was started and HBV infection was monitored with monthly determination of liver enzymes and HBV-DNA, according to a pre-emptive approach. After one month the patient was asymptomatic, liver enzymes remained unchanged, while HBV-DNA became detectable (41 IU/ml). After two months HBV-DNA increased to 132 IU/ml, while liver enzymes remained within normal ranges and patient was still asymptomatic. A treatment for HBV infection with entecavir 0,5 mg once daily was started. The patient is currently under follow-up and HBV-DNA will be assessed monthly. HBV genotyping is underway for resistance mutation detection. Ocrelizumab should be re-administered in three months.
Ocrelizumab can reactivate HBV infection in PPMS patients. HBV-DNA monthly assessment is a valid method to detect pre-clinical HBV reactivation, in HBsAg negative, HBV-DNA negative and HBcAb positive subjects under ocrelizumab treatment. A pre-emptive approach could be an effective strategy for the management of patients with HBV reactivation risk. Prompt treatment with HBV specific nucleoside analogues can limit virus reactivation, avoiding ocrelizumab discontinuation.
Disclosure: Maria Rosa Ciardi: nothing to disclose
Marco Iannetta: nothing to disclose
Maria Antonella Zingaropoli: nothing to disclose
Simona Pontecorvo: nothing to disclose
Rosanna Annecca: nothing to disclose
Marta Di Folco: nothing to disclose
Claudio Maria Mastroianni: nothing to disclose
Vincenzo Vullo: nothing to disclose
Abstract: EP1671
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Ocrelizumab is a disease-modifying therapy (DMT) belonging to the family of anti-CD20 monoclonal antibodies. This drug targets B cells expressing the CD20 receptor and has been recently approved for the treatment of primary progressive (PP) and relapsing (R) multiple sclerosis (MS). Risk of infections is increased during ocrelizumab treatment. Although Hepatitis B virus (HBV) reactivation is considered a possible event because of the evidences coming from similar DMT targeting B cells, no cases of HBV reactivation have been reported for ocrelizumab, so far. Here we describe the first case of HBV reactivation in a patient under ocrelizumab treatment. A 60-year-old Caucasian male affected by PPMS since 2012, with an expanded disability status scale of 6.5 and previously treated with azathioprine, was started on ocrelizumab in February 2018, receiving two administrations of the drug (15 days apart). Pre-ocrelizumab serologic tests showed the presence of antibodies against HBV surface and core antigens (HBsAb and HBcAb, respectively), while HBV surface and e antigens (HBsAb and HBeAg, respectively) and antibodies against HBV e antigen (HBeAb) were negative. Furthermore, pre-ocrelizumab HBV-DNA was undetectable (< 20 IU/ml) and liver enzymes were within normal ranges. Considering the status of HBV inactive carrier, ocrelizumab treatment was started and HBV infection was monitored with monthly determination of liver enzymes and HBV-DNA, according to a pre-emptive approach. After one month the patient was asymptomatic, liver enzymes remained unchanged, while HBV-DNA became detectable (41 IU/ml). After two months HBV-DNA increased to 132 IU/ml, while liver enzymes remained within normal ranges and patient was still asymptomatic. A treatment for HBV infection with entecavir 0,5 mg once daily was started. The patient is currently under follow-up and HBV-DNA will be assessed monthly. HBV genotyping is underway for resistance mutation detection. Ocrelizumab should be re-administered in three months.
Ocrelizumab can reactivate HBV infection in PPMS patients. HBV-DNA monthly assessment is a valid method to detect pre-clinical HBV reactivation, in HBsAg negative, HBV-DNA negative and HBcAb positive subjects under ocrelizumab treatment. A pre-emptive approach could be an effective strategy for the management of patients with HBV reactivation risk. Prompt treatment with HBV specific nucleoside analogues can limit virus reactivation, avoiding ocrelizumab discontinuation.
Disclosure: Maria Rosa Ciardi: nothing to disclose
Marco Iannetta: nothing to disclose
Maria Antonella Zingaropoli: nothing to disclose
Simona Pontecorvo: nothing to disclose
Rosanna Annecca: nothing to disclose
Marta Di Folco: nothing to disclose
Claudio Maria Mastroianni: nothing to disclose
Vincenzo Vullo: nothing to disclose