Cladribine Shows Quality of Life Improvements in Multiple Sclerosis


Data from the CLARIFY-MS study showed significant improvements in Multiple Sclerosis Quality of Life-54 physical and mental composite scores, with consistent safety and tolerability among patients with MS.

Alessandra Solari, MD, head, Unit of Neuroepidemiology, Scientific Directorate at the Foundation IRCCS Carlo Besta Neurological Institute

Alessandra Solari, MD

Data from the CLARIFY-MS study (NCT03369665) suggest that treatment with cladribine (Mavenclad; EMD Serono) can improve both physical and mental aspects of quality of life among patients with multiple sclerosis (MS). Additionally, no new safety signals emerged over the course of the 2-year treatment period.1

Presented at the 2022 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, held October 26-28, in Amsterdam, the Netherlands, the study was designed to assess health-related quality of life (HRQoL), using the Multiple Sclerosis Quality of Life-54 (MSQoL-54) questionnaire, among individuals with highly-active relapsing MS. The cohort included 482 patients treated with a 3.5-mg/kg cumulative dose of cladribine, of whom 120 were treatment naïve and 313 had been treated with prior disease-modifying therapy (DMT). The mean age of patients was 37.4 years and 70.1% of the cohort was female.

All told, at the 24-month mark, MSQoL-54 physical composite scores were changed by a mean of 4.86 points (95% CI, 3.18-6.53) from baseline and mental health composite scores were changed by 4.80 points (95% CI, 3.13-6.46), both of which were statistically significant (P <.0001). Notably, these changes in MSQoL-54 scores were consistent across both the treatment-naïve and treatment-experienced subgroups.

It is well recognized that multiple sclerosis is associated with negative effects on many aspects of patients’ quality of life (including physical and mental health) that may not be adequately treated,” study investigator Alessandra Solari, MD, head, Unit of Neuroepidemiology, Scientific Directorate at the Foundation IRCCS Carlo Besta Neurological Institute, and colleagues wrote, pointing to the importance—and focus of the field in recent years—of improving quality of life.1

As for safety, at least 1 treatment-emergent adverse event (TEAE) was experienced by 376 patients (78.0%). The most commonly reported TEAEs were headache, lymphopenia, and nasopharyngitis, with treatment interruption occurring in 9 patients (1.9%) because of TEAEs. The majority of lymphopenia events post treatment were grade 1 or 2 (grade 1, 19.9%; grade 2, 42.1%), though 19.7% of patients experienced grade 3 lymphopenia. No grade 4 lymphopenia was observed in CLARIFY-MS, and severe or opportunistic infections were rare, according to Solari et al, which was “in line with prior data.”

Additional data presented at ECTRIMS on cladribine’s use in a real-world setting suggested that those who switched their treatment to it from infusion therapies experienced reduced annualized relapse rates (ARRs) and tolerated the oral purine antimetabolite well. All told, the ARRs for the cohort 1 year and 2 years prior to a switch in disease-modifying therapy (DMT) were 0.58 and 0.7, respectively. Over the 2-year course of the study (May 2019 to March 2022), the post-DMT switch ARR was 0.17 for patients with at least 1 year of follow-up (n = 23).2

That prospective and retrospective chart review study, conducted by Negroski et al at the MS Center of Sarasota, included 84 individuals with relapsing MS. Those included were between 18 and 74 years old and were treated with at least 1 dose of oral cladribine. Of those 84 individuals, 33 (39.3%) switched from high-efficacy infusion treatments, including ocrelizumab (Ocrevus; Genentech), natalizumab (Tysabri; Biogen), and alemtuzumab (Lemtrada; Sanofi Genzyme).2

In recent years, as treatments have advanced to better control disease relapses, the MS field has turned its attention toward improving symptomatic care, including quality of life and disease burden. In a NeurologyLive® Ever-Changing Face of MS series, Ahmed Obeidat, MD, PhD; Randall Schapiro, MD, FAAN; and Jeffrey Wilken, PhD, provide insight into the impact multiple sclerosis can have on patients and hypothesize about initiating treatment before cognitive impairment is observed. Check out part of their conversation below.

Click here for more coverage of ECTRIMS 2022.

1. Solari A, Montalban X, Lechner-Scott J, et al. Improvements in quality of life over 2 years in patients treated with cladribine tablets for highly active relapsing multiple sclerosis: Final analysis of CLARIFY-MS. Presented at: ECTRIMS Congress; October 26-28, 2022; Amsterdam, Netherlands. P108.
2. Negroski D, Sellers S, Khiabani A, Khiabani D. Real-world experience switching from high-efficacy infusions to cladribine tablets. Presented at: ECTRIMS Congress; October 26-28, 2022; Amsterdam, Netherlands. EP1055.
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