Contributions
Abstract: P1243
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Introduction: Alemtuzumab is a humanized IgG1 kappa monoclonal antibody approved for treatment relapsing remitting Multiple Sclerosis (RRMS) in Australia. Immune thrombocytopenia (ITP) was recognised in both phase 2 and 3 clinical trials of alemtuzumab as a potential risk factor with this treatment. In the phase 2 clinical trial of annual alemtuzumab for treatment of RRMS, 6 of 216 patients (2.8%) developed ITP. Over mean follow-up of 4.5 years, the incidence rate of ITP was 6.2 (95% confidence interval, 2.3-13.3) per 1000 person-years. Median times from initial and last alemtuzumab exposure to ITP diagnosis were 24.5 and 10.5 months, respectively1. In the phase 3 trials CARE MS 1 and 2, the overall rate of ITP on Alemtuzumab 12mg annual dose was 1.6%. Previously ITP associated with alemtuzumab treatment was characterized by delayed presentation after drug exposure, responsiveness to conventional ITP therapies, and prolonged remission.
Study: We present a 42 year old woman with a diagnosis of RRMS in 2007, who was treated without complication in our hospital with first course alemtuzumab 22-26.6.2015. Her routine post Alemtuzumab monthly full blood examination on 20.8.2015 was normal, platelet count was 296. On 31.8.2015 she reported a single mouth lesion and small cluster of petechiae on chest, legs, and stomach. She was advised to have her platelets retested as soon as possible and on the following day the result was a count of 14 with no other abnormalities. She was immediately admitted to our hospital, and treated with weaning doses of oral prednisolone, starting dose of 75mg daily. Three days after her admission her platelets increased from 6 at admission to 33 and she was discharged. She was managed as an outpatient with weaning prednisolone over the next 4 months.
Conclusion: Our case highlights the need for clinicians to maintain a high level of vigilance and routine monitoring for ITP in patients treated with alemtuzumab. Routine pathology monitoring is recommended as monthly for 5 years with patients treated with alemtuzumab. However this case occurred outside the routine monitoring schedule, earlier than previously reported and with minor symptomatology. This case highlights the need for a comprehensive patient education approach and provision of services that enable prompt responses to patient"s queries and concerns.
Disclosure: Jodi Haartsen has received honoraria from Biogen idec, Merck-serono, Novartis, CSL and Genzyme for speaking, advisory Boards and conference attendance
Dr Sarah CM Lee has nothing to disclose
Dr Olga Skibina has received honoraria from Biogen idec, Merck-serono, Novartis and Genzyme for speaking, Advisory Boards and conference attendance and educational grant.
Abstract: P1243
Type: Poster
Abstract Category: Therapy - disease modifying - Risk management for disease modifying treatments
Introduction: Alemtuzumab is a humanized IgG1 kappa monoclonal antibody approved for treatment relapsing remitting Multiple Sclerosis (RRMS) in Australia. Immune thrombocytopenia (ITP) was recognised in both phase 2 and 3 clinical trials of alemtuzumab as a potential risk factor with this treatment. In the phase 2 clinical trial of annual alemtuzumab for treatment of RRMS, 6 of 216 patients (2.8%) developed ITP. Over mean follow-up of 4.5 years, the incidence rate of ITP was 6.2 (95% confidence interval, 2.3-13.3) per 1000 person-years. Median times from initial and last alemtuzumab exposure to ITP diagnosis were 24.5 and 10.5 months, respectively1. In the phase 3 trials CARE MS 1 and 2, the overall rate of ITP on Alemtuzumab 12mg annual dose was 1.6%. Previously ITP associated with alemtuzumab treatment was characterized by delayed presentation after drug exposure, responsiveness to conventional ITP therapies, and prolonged remission.
Study: We present a 42 year old woman with a diagnosis of RRMS in 2007, who was treated without complication in our hospital with first course alemtuzumab 22-26.6.2015. Her routine post Alemtuzumab monthly full blood examination on 20.8.2015 was normal, platelet count was 296. On 31.8.2015 she reported a single mouth lesion and small cluster of petechiae on chest, legs, and stomach. She was advised to have her platelets retested as soon as possible and on the following day the result was a count of 14 with no other abnormalities. She was immediately admitted to our hospital, and treated with weaning doses of oral prednisolone, starting dose of 75mg daily. Three days after her admission her platelets increased from 6 at admission to 33 and she was discharged. She was managed as an outpatient with weaning prednisolone over the next 4 months.
Conclusion: Our case highlights the need for clinicians to maintain a high level of vigilance and routine monitoring for ITP in patients treated with alemtuzumab. Routine pathology monitoring is recommended as monthly for 5 years with patients treated with alemtuzumab. However this case occurred outside the routine monitoring schedule, earlier than previously reported and with minor symptomatology. This case highlights the need for a comprehensive patient education approach and provision of services that enable prompt responses to patient"s queries and concerns.
Disclosure: Jodi Haartsen has received honoraria from Biogen idec, Merck-serono, Novartis, CSL and Genzyme for speaking, advisory Boards and conference attendance
Dr Sarah CM Lee has nothing to disclose
Dr Olga Skibina has received honoraria from Biogen idec, Merck-serono, Novartis and Genzyme for speaking, Advisory Boards and conference attendance and educational grant.