Real world experience with cladribine treatment in Slovakia

ABSTRACT

Background: Data from registration studies indicate that cladribine is effective for the treatment of MS and has a promising safety and tolerability profile. However, careful long-term monitoring is needed. Real world data could provide valuable information about cladribin in routine clinical practice. Objective(s) This paper present a retrospective analysis of the effectiveness and safety of cladribine treatment in two MS Centers in Slovakia. Method(s) We performed a retrospective cohort study of 93 patients with relapsing MS, receiving cladribine treatment since December 2018 to May 2022. One patient was excluded, followup was lost. We collected information about relapses, disability (using EDSS), and MRI activity before and during cladribine treatment. Data about previous immunomodulatory medicaments (IMT) and adverse events associated with cladribine treatment were also found. Result(s) Mean age of group was 44years, 71% were women. Before starting cladribine mean EDSS was 4.4 (+/- 3.1), disease duration was 11.6 (+/- 8.3), 97.8% patients experienced relapses and 25.8% had MRI activity. Before starting cladribine treatment, 33% received 1 IMT, 27% were on 2 IMT, and 33% were on >= 3 IMT. 7 patients were IMT-naiive. Patients were most frequently switched to cladribine from dimetylfumarate and teriflunomide. In Year I cladribine treatment,86% (n = 78) of patients did not experience a relapse, and 79% of patients had no radiological activity, 96% of patients had no increase in EDSS following cladribine treatment. In Year II, 83% (n = 53) of patients did not experience a relapse, 92% of patients had no radiological activity, and 80% of patients had no increase in EDSS following cladribine tablets treatment. In Year III, 93% (n = 30) of patients did not experience a relapse, 88% of patients had no radiological activity, and 96% of patients had no increase in EDSS. None of the patient had grade 4 lymphopenia. Lymphopenia grade 2 was the most frequent (41%). We detected one case of mammal carcinoma and 2 precancerosis (dysplasio cervicis uteri) after Year I. The patients did not continue in treatment. Upper respiratory tract infections, Covid-19, fatigue, back pain and artralgy were most common adverse effects in the group. Conclusion(s) Our study confirmed high long-term efficacy of cladribine in MS patients. Considering relative risk of cancer we strictly require patients to have a periodic preventive medical evaluation.