A swedish post-market surveillance study: long-term effectiveness and safety of cladribine tablets (IMSE 10) for patients treated at least 12 months

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A swedish post-market surveillance study : long-term effectiveness and safety of cladribine tablets (IMSE 10) for patients treated at least 12 months

Forsberg, L. (author): Karolinska Institutet, Solna, Sweden

Kågström, S. (author): Karolinska Institutet, Solna, Sweden

Leandersson, Å. (author): Karolinska Institutet, Solna, Sweden

Hillert, J. (author): Karolinska Institutet, Solna, Sweden

Nilsson, P. (author): Lund Univiversity, Lund, Sweden

Dahle, C. (author): Linköping University, Linköping, Sweden

Svenningsson, A. (author): Danderyd Hospital, Danderyd, Sweden

Lycke, J. (author): Institute of Neuroscience and Physiology, Gothenburg, Sweden

Landtblom, A. -M (author): Uppsala University, Uppsala, Sweden

Burman, J. (author): Uppsala University, Uppsala, Sweden

Martin, C. (author): Danderyd Hospital, Danderyd, Sweden

Sundström, P. (author): Umeå University, Umeå, Sweden

Gunnarsson, Martin, 1973- (author): Örebro universitet,Institutionen för medicinska vetenskaper

Piehl, F. (author): Karolinska Institutet, Solna, Sweden

Olsson, T. (author): Karolinska Institutet, Stockholm, Sweden

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Sage Publications, 2020
2020
English.
In: Multiple Sclerosis Journal. - : Sage Publications. - 1352-4585 .- 1477-0970. ; 26:3 Suppl., s. 254-254

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Journal article (other academic/artistic)

Abstract Subject headings

Background: Cladribine is a deoxyadenosine analogue prodrug. Cladribine tablets (CT) are administered in two courses, 12 months apart, for patients with relapsing multiple sclerosis (RMS). CT are included in the Swedish post-market surveillance study “Immunomodulation and Multiple Sclerosis Epidemiology” (IMSE).Objectives: To assess the safety and effectiveness of CT in a real-world setting 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: 85 patients were included in the IMSE 10 study since CT were introduced on the Swedish market in April 2018. 42 patients were treated for at least 12 months. Five AEs were reported since the study start, four were classified as infections and infestations. 25 % of the entire cohort was treated with CT as their first MS drug. 13 % were treated with natalizumab and 12 % with dimethyl fumarate prior to CT. Five AEs were reported since the study start, four were classified as infections and infestations. Relapse data was available for 27/42 patients in the 12-month cohort. The number of reported relapses decreased significantly from 208.6 per 1,000 patient years before treatment start to 83.6 during treatment. Only three patients in this cohort experienced a relapse during treatment of which two were during the first treatment year. Significant improvements in mean values at 12 months of treatment compared to baseline were noted for MSSS for the 12-month cohort (n=17). All other tests remained stable but significantly unchanged after one year of treat-ment. Lymphocyte levels decreased from a mean of 2.4 x 109/L at treatment start (n=8) to 1.2 x 109/L after 12 months of treatment (n=6) in the 12-month cohort. No patients were below the 0.8 x 109/L limit at 12 months.Conclusions: CT treatment demonstrates clinical stability in patients treated 12 months. However, continued follow-up is needed to assess the effectiveness and safety of CT over a longer time to assess if these results sustain after the final treatment course has been administered.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)

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By the author/editor: Forsberg, L.; Kågström, S.; Leandersson, Å.; Hillert, J.; Nilsson, P.; Dahle, C.; show more...; Svenningsson, A.; Lycke, J.; Landtblom, A. -M; Burman, J.; Martin, C.; Sundström, P.; Gunnarsson, Mart ...; Piehl, F.; Olsson, T.; show less...

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Neurology

Articles in the publication: Multiple Scleros ...

By the university: Örebro University

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