Clinical effectiveness and safety of cladribine tablets for patients treated at least 12 months in the swedish post-market surveillance study "immunomodulation and multiple sclerosis epidemiology 10" (IMSE 10)Show others and affiliations
2021 (English)In: Multiple Sclerosis Journal, ISSN 1352-4585, E-ISSN 1477-0970, Vol. 27, no Suppl. 2, p. 623-624Article in journal, Meeting abstract (Other academic) Published
Abstract [en]
Background: Cladribine is a deoxyadenosine analogue prodrug that selectively induces immune reconstitution by targeting B- and T-lymphocytes. Cladribine tablets (CladT) are administered in two courses, 12 months apart, for patients with relapsing multiple sclerosis (RMS). CladT are included in the Swedish post-market surveillance study “Immunomodulation and Multiple Sclerosis Epidemiology” (IMSE).
Objective: To assess the safety and effectiveness of CladT with focus on patients treated at least 12 months.
Methods: Descriptive data of Extended Disability Status Scale (EDSS), Multiple Sclerosis Severity Scale (MSSS), Symbol Digit Modalities Test (SDMT), Multiple Sclerosis Impact Scale (MSIS-29), European Quality of Life-5 Dimensions Test (EQ-5D), Visual Analog Scale (VAS), relapses and Adverse Events (AEs) is obtained from the nationwide Swedish Neuro Registry (NeuroReg). Effectiveness measures were assessed using the Wilcoxon Signed Rank Test and relapse rates were tested using the paired samples T-test.
Results: 140 patients were included in the IMSE 10 study since the Swedish market launch in April 2018 with a one year drug survival rate of 96.5%. 6 patients discontinued treatment, of which 2 later restarted. 18 AEs were reported of which 5 were serious. The most common AE reported were infection and infestation (8 reports). 22% of the patients was treated with CladT as their first MS drug. 18% were treated with natalizumab and 11% with dimethyl fumarate prior to CladT.
83 patients were treated for at least 12 months. Relapse data was available for 47 of 83 patients in the 12-month cohort. The number of relapses decreased significantly from 249.6 per 1,000 patient years before treatment start to 53.5 during treatment. Only 5 patients in this cohort experienced a relapse during treatment.Significant improvements in mean values at 12 months of treatment compared to baseline were noted for MSSS (p=0.007) and VAS (p=0.029) for the 12-month cohort. All other tests remained stable but significantly unchanged after one year of treatment.Lymphocyte levels decreased from a mean of 1.8 x 109/L at treatment start (n=39) to 1.1 x 109/L after 12 months of treatment (n=37).
Conclusions: CladT treatment demonstrates clinical stability in patients treated ⩾ 12 months. However, continued follow-up is needed to assess the effectiveness and safety of CladT over a longer time to assess if these results sustain after the final treatment course has been administered.
Place, publisher, year, edition, pages
Sage Publications, 2021. Vol. 27, no Suppl. 2, p. 623-624
National Category
Neurology
Identifiers
URN: urn:nbn:se:oru:diva-95641ISI: 000706771302119OAI: oai:DiVA.org:oru-95641DiVA, id: diva2:1615189
Conference
37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS 2021), The Digital Experience, October 13-15 2021
2021-11-292021-11-292022-09-15Bibliographically approved