Real-Life Study with Cladribine: Kuwait Experience

Objective(s) To study the effectiveness and the safety of Cladribine treatment in MS patients in a real-world clinical setting. Material(s) and Method(s) This observational, prospective study included MS patients who had at least one year follow-up after Cladribine initiation. Baseline patient clinical and radiological characteristics recorded within one year prior to Cladribine initiation. The relapse rate, disability measures, Result(s) A total of seventy-two patients, 59 (81.9%) were females, mean age 36.32 +10.06 years old, mean disease duration 7.21+6.19. Most patients (n=32; 44.4%) were naïve to any treatment. Cladribine was started in 53 (73.6%) patients due to disease breakthrough. Forty patients (55.6%) completed two courses of treatment. Most of our cohort was relapse free (85% versus 25%; P<0.001) and few 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. ARR was significantly reduced 0.15 +0.36 versus 0.85+0.53; P<0.01). Most of cohort 90% has no progression of disability. 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; 11.2%)lymphocytopenia (n=3; 5.6%), and elevated liver enzymes (n=1; 1.9%) were reported. Conclusion(s) The effectiveness and safety profile of cladribine in this study were consistent with data of phase 3 clinical trials. Early initiation of cladribine is associated with favorable outcome. To study the effectiveness and the safety of Cladribine treatment in MS patients in a real-world clinical setting. This observational, prospective study included MS patients who had at least one year follow-up after Cladribine initiation. Baseline patient clinical and radiological characteristics recorded within one year prior to Cladribine initiation. The relapse rate, disability measures, A total of seventy-two patients, 59 (81.9%) were females, mean age 36.32 +10.06 years old, mean disease duration 7.21+6.19. Most patients (n=32; 44.4%) were naïve to any treatment. Cladribine was started in 53 (73.6%) patients due to disease breakthrough. Forty patients (55.6%) completed two courses of treatment. Most of our cohort was relapse free (85% versus 25%; P<0.001) and few 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. ARR was significantly reduced 0.15 +0.36 versus 0.85+0.53; P<0.01). Most of cohort 90% has no progression of disability. 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; 11.2%)lymphocytopenia (n=3; 5.6%), and elevated liver enzymes (n=1; 1.9%) were reported. The effectiveness and safety profile of cladribine in this study were consistent with data of phase 3 clinical trials. Early initiation of cladribine is associated with favorable outcome.