Additional Cladribine data reinforces efficacy in RMS patients

• Post-hoc analysis of CLARITY study demonstrates clinical and Magnetic Resonance Imaging efficacy in subgroups of both younger and older adults treated with Cladribine Tablets
• Analysis with Multi-Criteria Decision Analysis (MCDA) methodology provided results comparing EU-approved Cladribine Tablets with other approved treatments in patients with highly active MS

Merck KGaA announced the presentation of new efficacy and benefit-risk assessment data for Cladribine Tablets at the 4th Congress of the European Academy of Neurology (EAN), in Lisbon, Portugal. Results of a retrospective analysis of the Phase III CLARITY study showed clinical and Magnetic Resonance Imaging (MRI) benefits in patients with relapsing remitting multiple sclerosis (RRMS) aged ≤50 and >50 years and treated with Cladribine Tablets, with improvements observed in both relapse rate and MRI outcomes when compared with placebo.

The aim of the post-hoc analysis of the Phase III CLARITY study was to investigate whether the clinical and MRI effects of Cladribine Tablets are consistent in both older and younger patients. The results highlight the improvements observed in annualized relapse rate (ARR) and MRI outcomes versus placebo in both subgroups of RRMS patients, ≤50 and >50 years; Cladribine Tablets reduced relapse risk compared to placebo by 59% and 52%, respectively. In placebo treated patients, there were higher mean numbers of new T1 Gd+ and active T2 lesions for those aged ≤50 years compared to patients aged >50. Despite this, treatment with Cladribine Tablets demonstrated significant effects on MRI measures in both age groups (P<0.0001).

Additional data presented at EAN 2018 provide the results of the EMA-recommended application of Multi-Criteria Decision Analysis (MCDA) methodology to assess the benefit-risk profile of Cladribine Tablets, which is approved in Europe for the treatment of highly active relapsing forms of multiple sclerosis as defined by clinical or imaging features, to assess the benefit-risk profile of Cladribine Tablets preferences among five blinded treating neurologists in Europe, versus other  approved DMDs, in MS patients with high disease activity. Results of this analysis suggest a comparable benefit-risk profile for Cladribine Tablets in patients with high disease activity when compared to that of five other DMDs, in this assessment.

“The presentation of these data highlight our ongoing commitment to understanding the full benefit-risk profile of Cladribine Tablets in a broad range of patients. Post hoc data from the CLARITY study, coupled with results from a Multi-Criteria Decision Analysis, which are based on expert physician assessment and practice-relevant treatment considerations, form a potentially useful tool for physicians in countries where Cladribine Tablets is approved to evaluate therapy options for patients with high disease activity,” said Luciano Rossetti, Head of Global R&D for the biopharma business of Merck KGaA, Darmstadt, Germany. “The MCDA methodology is one that is recommended by EMA, and we are pleased that Cladribine Tablets performed well using this approach.”

Furthermore, additional post-hoc data from clinical studies of patients treated with Rebif (interferon beta-1a) showed that the MAGNIMS score at Year 1 reliably predicted long-term clinical disease activity (CDA)-free status and disability progression. At Year 1 the median time to a CDA event was longer in patients with a MAGNIMS score of 0, versus those with score 1 or 2. Additionally, median time to Expanded Disability Status Scale (EDSS) progression was found to be longer in patients with a Year 1 MAGNIMS score of 0 (7.5 years), versus those with a score of 1 (4.0 years) or 2 (2.5 years).

Additionally, a presentation from the Merck KGaA, Darmstadt, Germany-sponsored MS in the 21st Century joint patient-physician steering group highlighted the results of an international unmet needs survey, suggesting a disconnect between patients’ and physicians’ perspectives of MS treatment decisions. The results of this survey indicate that MS patients have different perceptions of the current unmet needs in the disease area compared to healthcare professionals (HCPs). Whilst 87.7% of HCPs considered that they involved their patients in the decision-making process, only 38.9% of patients reported they felt involved. Addressing this disconnect between patients’ and physicians’ perspectives during treatment discussions could lead to an improved dialogue between HCPs and patients, an integral step towards finding appropriate individualised treatment approaches for each patient.

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News Source: EMD Serono Website