As promised my slides from my presentation at the Neuro Forum meeting in Lublin, Poland. I feel very much at home here amongst a friends of cladribine. The MS clinic in Lublin has the most experience in the use of off-label cladribine, having treated ~400 patients with the drug. There results are very promising and my friend, and colleague, Professor Konrad Rejdak, who is now the head of department in Lublin, is studying the long-term impact of the cladribine on the disease. He presented a poster at ECTRIMS on the safety of using the drug in SPMS.
We are convinced that cladribine may have an impact on the pathology of MS within the CNS and are hoping to get a trial funded to test cladribine in more advanced MS, including pwMS in wheelchairs. This is one of our motivations for running the #ThinkHand campaign. I have urged Professor Rejdak and his colleagues to study the impact of cladribine on the intrathecal (within the CNS) immune response. If we can show that cladribine impacts on MS pathology within the CNS then we will have a much stronger case for doing a trial in progressive MS. DrK is leading on this study and is quite advanced stage in its design. Over the next few months Barts-MS will be making a strong case for getting this trial funded and started.
P1146: Rejdak et al. Induction therapy of relapsing secondary progressive multiple sclerosis using generic cladribine. ECTRIMS 2016.
Background: Evidence suggests Cladribine is an effective, safe and convenient disease modifying induction therapy for people with multiple sclerosis.
Objective: To report our experience using subcutaneous Cladribine as a treatment for people with relapsing secondary progressive MS (SPMS).
Methods: Study was performed at the Department of Neurology,Medical University of Lublin and received local ethics approval.Cladribine (Biodribine) was offered to 45 patients with SPMS (30 women and 15 men; aged 42 years [25-56]; EDSS = 6 [2-7], disease duration= 10 years [5-15]; median, range). Cladribine was given subcutaneously at a dose of 0.07 mg/kg/day for 4-6 days.
Treatment courses were given every 5 weeks for a total of five courses (total dose: 1.4 – 2.1 mg/kg). Blood samples were collected before treatment initiation, before each subsequent treatment course, and three months after the last dose. Patients were followed-up for initial 28 weeks of treatment course, and there was extended follow up of up to 5 years to record relapses, disability progression and adverse events.
Results: All patients completed the follow-up period. Cladribine induced a gradual decline in the total lymphocyte count from 1.8±0.5 (x10*9/L; mean±SD) at baseline to 1.5±0.5 after the 1st, 1.3±0.5 after the 2nd; 1.0±0.4 after the 3rd; 1.0±0.4 after the 4th, and 0.9±0.3 after the 5th doses, respectively. Lymphocyte count then remained stable for 3 months after follow up (0.9±0.4). The total white cell count was also reduced however remained within the normal range throughout the observation period (6.4±1.6 x10*9/L at baseline, and 5.5±2.7 at last follow up). Other blood counts remained unaffected. In seven cases mild infections occurred during the follow-up period. No serious adverse events, relapses or disability progression were observed.
Conclusion: Cladribine induction therapy was safe and well tolerated in people with SPMS followed up for 28 weeks. Extended follow-up is underway to collect further data on safety and efficacy.