A prospective observational longitudinal study with a two-year follow-up of multiple sclerosis patients on Cladribine
Affiliations
Affiliations
- Department of Neurology, Ibn Sina Hospital, P.O. Box 25427, Safat 13115, Kuwait; Department of Medicine, Faculty of Medicine, Kuwait University, P.O. Box 24923, Safat 13110, Kuwait. Electronic address: dralhasel@hotmail.com.
- Department of Neurology, Ibn Sina Hospital, P.O. Box 25427, Safat 13115, Kuwait; Department of Neurology and Psychiatry, Minia University, P.O. Box 61519, Minia 61111, Egypt.
- Department of Medicine, Faculty of Medicine, Kuwait University, P.O. Box 24923, Safat 13110, Kuwait.
- Division of Neurology, Amiri Hospital, Arabian Gulf Street, Sharq 13041, Kuwait; MS Clinic, Ibn Sina Hospital, P.O. Box 25427, Safat 13115, Kuwait.
Abstract
Background: Cladribine was approved for the treatment of multiple sclerosis (MS). Real-world data is very limited.
Objectives: To study the effectiveness and the safety of Cladribine treatment in only one group of MS patients after treatment with Cladribine for two years.
Methods: This observational, longitudinal prospective study. Eligible subjects were relapsing remitting MS patients who had at least two-year follow-up after Cladribine treatment. The primary endpoint was the proportion of relapse free patients. Secondary endpoints were ARR, change in EDSS scores, the proportion of patients with CDP, MRI activity, and NEDA-3 status, also the rate of occurrence of AEs. Patients were assessed for primary and secondary endpoints at the end of two years of follow-up.
Results: Of a total of seventy-two patients, 59 (81.9 %) were females, mean age of 36.32 + 10.06 years old, mean disease duration 7.21 + 6.19. Most patients (n = 32; 44.4 %) were naïve to any treatment. Forty patients (55.6 %) completed two courses of treatment. The primary endpoint showed that most of our cohort was relapse free (85 % versus 25 %; P < 0.001), Secondary endpoints showed that ARR was significantly reduced 0.15 + 0.36 versus 0.85 + 0.53; P < 0.01). Most of the cohort 90 % have no progression of disability. Few subjects had new T2 lesions (7.5 % versus 70.8 %; P < 0.001 and gadolinium enhancement 5 % versus 66.7 %; P < 0.001) in MRI compared to baseline. No evidence of disease activity 3 (NEDA-3) was achieved in 30 (75 %) patients. It was achieved in 87.5 % of naive patients versus 66.7 % in patients who received prior disease modification drugs before Cladribine initiation. Infections 6 (n = 6; 8.4 %) lymphocytopenia (n = 3; 4.2 %), and elevated liver enzymes (n = 1; 1.4 %) were reported.
Conclusion: Cladribine treatment reduced significantly relapse rate and MRI activity. It was safe and tolerable. Early initiation of cladribine is associated with favorable outcomes.
Keywords: Cladribine; Real-world evidence; Treatment response.
Conflict of interest statement
Conflicts of Interest All authors declare that this study has no commercial or financial relationships that could be construed as a potential conflict of interest.