Real world experience with Cladribine at S.Andrea Hospital of Rome

Expert opinion on the long-term use of cladribine tablets for multiple sclerosis: Systematic literature review of real-world evidence

“…Breakthrough DA is a known phenomenon, particularly when switching from fingolimod or natalizumab (Barry et al, 2019;Prosperini et al, 2019) and appears to occur in some patients irrespective of subsequent DMT. Relapses in the first 12 months of real-world treatment with CladT occur in a minority of patients, and do not normally lead to treatment discontinuation (Barbuti et al, 2021;Barros et al, 2020;Ciampi et al, 2021;Horáková et al, 2021;Pfeuffer et al, 2022;Santos et al, 2021;Thakre and Inshasi, 2020;Eichau et al, 2021) suggesting low-level DA in most cases. Rarely, a severe rebound may be observed where DA is unabated or paradoxically increased, versus pre-treatment levels.…”

“…Sixteen of these reported incidence of relapses within the first year (Annovazzi et al, 2020;Bain et al, 2020;Barbuti et al, 2021;Barros et al, 2020;Celius and Berg-Hansen, 2019;Ciampi et al, 2021;Forsberg et al, 2020;Horáková et al, 2021;Kalincik et al, 2018; Pfeuffer et al, 2022, Rojas et al, 2021Rosengren et al, 2021;Santos et al, 2021, Thakre andInshasi, 2020;Viitala et al, 2020;Ziemssen et al, 2021) and five reported MRI activity in the first year (Barbuti et al, 2021;Horáková et al, 2021;Rojas et al, 2021;Thakre and Inshasi, 2020;Eichau et al, 2021). The proportion of patients relapsing within the first 6 and 12 months ranged from 1.1 to 10% (Bain et al, 2020;Celius and Berg-Hansen, 2019;Thakre and Inshasi, 2020;Ziemssen et al, 2021) and 4.8 to 21.9% (Annovazzi et al, 2020;Barbuti et al, 2021;Barros et al, 2020;Ciampi et al, 2021, Forsberg et al, 2020Horáková et al, 2021;Kalincik et al, 2018;Pfeuffer et al, 2022, (Thakre and Inshasi, 2020). Details and timing of rebaselining scans were not provided in these studies, which may account for differences in rates of MRI activity within the first year.…”

“…Fourteen studies reported on discontinuation/switch rates within the first year; rates ranging from 0-11%. Discontinuations/switches due to ongoing DA were reported in 0-7.4% (Barbuti et al, 2021;Barros et al, 2020;Ciampi et al, 2021;Horáková et al, 2021;Pfeuffer et al, 2022;Santos et al, 2021;Thakre and Inshasi, 2020;Eichau et al, 2021). Two studies reported subsequent disease-modifying therapies (DMTs); Ciampi et al (2021) reported that 2/34 (5.9%) of patients switched to ocrelizumab due to CladT treatment failure and similarly, Pfeuffer et al (2022) detailed a switch to ocrelizumab in 3/270 (1.1%) of patients, due to ongoing DA.…”

“…Abs, abstract; ARR, annualised relapse rate; CladT, cladribine tablets; CLEVER, CLadribine Tablets -EValuation of thERapy satisfaction; CI, confidence interval; DA, disease activity; DMF, dimethyl fumarate; DMT, disease-modifying therapy; EDSS, Expanded Disability Status Scale; Gd+, gadolinium enhancing; HR, hazard ratio; IMSE, immunomodulation and multiple sclerosis epidemiology; MERLYN, MavEnclad Real-worLd comparative efficacY non-iNterventional; MRI, magnetic resonance imaging; MS, multiple sclerosis; NEDA, no evidence of disease activity; N/S, not specified; UAE, United Arab Emirates Rojas et al, 2021;Rosengren et al, 2021;Santos et al, 2021;Thakre and Inshasi, 2020;Viitala et al, 2020),. respectively.Details of MRI outcomes (T2 and gadolinium enhancing [Gd+] T1) varied among studies Barbuti et al (2021). reported ≥ 1 new lesion in 16.7% of patients (n=60).…”

Holistic, Long-Term Management of People with Relapsing Multiple Sclerosis with Cladribine Tablets: Expert Opinion from France

“…of patients No. of discontinuations or switches [N (%)] [ 65 ] Canada 111 0 [ 66 ] Italy 60 1 (1.7) [ 67 ] Spain 85 5 (5.9) [ 68 ] Spain 88 2 (2.3) [ 69 ] Czechia 436 12 (2.8) [ 70 ] USA 616 6 (1.0) [ 71 ] Germany 270 3 (1.1) [ 72 ] Sweden 140 5 (3.5) [ 73 ] United Arab Emirates 88 1 (1.1) [ 14 ] Finland 179 4 (3) [ 74 ] International 610 1 (0.2) [ 75 ] International a 782 31 (4.0) [ 76 ] …”