An additional analysis of data from the CLARITY study confirmed the long-term benefits of treatment with Mavenclad (cladribine tablets) for patients with highly active relapsing forms of multiple sclerosis (MS).
The post-hoc analysis, “Efficacy of Cladribine Tablets in high disease activity subgroups of patients with relapsing multiple sclerosis: A post hoc analysis of the CLARITY study,” was published in the Multiple Sclerosis Journal.
The safety and effectiveness of the therapy was evaluated in several Phase 2 and 3 trials and extension studies, which involved more than 2,700 relapsing MS patients, some of whom were followed for more than 10 years.
To further evaluate the effectiveness of Mavenclad, researchers reanalyzed data from the Phase 3 CLARITY trial (NCT00213135) in patients with high disease activity. They included all patients whose condition fulfilled one of two clinically relevant definitions of high disease activity, which are commonly linked to poorer treatment response.
One group included all patients who had two or more relapses during the year prior to study entry, regardless of treatment status — the high relapse activity (HRA) group. The second group included patients who had one or more relapses and evidence of disease progression (increased number of brain lesions) during the year prior to study entry while on treatment, plus patients with HRA — high relapse activity plus disease activity on treatment (HRA+DAT).
Collectively, the post-hoc analysis included 289 MS patients who participated in the CLARITY trial. Of those who met the HRA+DAT criteria, 149 received placebo during the study and 140 were treated with 3.5 mg/kg of Mavenclad.
HRA and HRA+DAT patients showed increased rates of disease activity, as demonstrated by higher relapse rates, reduced time to first relapse, and worse disability scores, as measured by the expanded disability status scale (EDSS), compared with the overall MS population of the study.
Previous results of the CLARITY trial covering all 870 MS patients who participated revealed that treatment with 3.5 mg/kg of Mavenclad reduced the risk of six-month confirmed EDSS progression by 47%, compared with placebo.
This most recent analysis showed that HRA and HRA+DAT patient subgroups were even more protected against disease progression, with an 82% reduction in the risk of six-month confirmed EDSS progression, compared with placebo.
These patients also showed a tendency toward a greater decrease in the relative risk of relapses and of new brain lesions upon treatment with Mavenclad.
Researchers also evaluated disease-free status based on NEDA, or no evidence of disease activity, scores, defined as no relapses, no three-month confirmed EDSS progression, and no new or active lesions.
Patients classified as HRA+DAT were found to be 2.2 times more likely to achieve NEDA than non-HRA+DAT patients. A similar response was found in the HRA subgroup, but the difference with the non-HRA group was not statistically significant.
“This analysis provides valuable insights on the effect of Mavenclad on patients with ongoing disease activity despite treatment with platform therapy, as well as naïve patients with more relapses at baseline, who tend to do worse over time,” Gavin Giovannoni, lead investigator in the CLARITY studies and chair of neurology at Barts and The London School of Medicine and Dentistry, said in a press release.
“The efficacy data presented in this publication show an even greater risk reduction on expanded disability status scale (EDSS) progression with Mavenclad in patients with highly active MS,” Giovannoni said.
Patients with highly active disease were not found to be more prone to adverse reactions with Mavenclad treatment, and no new safety issues were reported, compared with the overall population.
These data demonstrate that HRA and HRA+DAT patients had better, or at least comparable, clinical and MRI responses to Mavenclad as those previously reported in the overall CLARITY MS population.
Mavenclad was developed by Merck KGaA, known as EMD Serono in the U.S. and Canada, to target immune T- and B-cells that trigger relapsing MS without suppressing the entire immune system. With a maximum of 20 days of treatment over two years, the oral treatment has been shown to help patients remain relapse-free for up to four years while working to “reset” the immune system.
The therapy is already approved for use in MS in Argentina, Canada, Australia, Israel, Europe, and the United Arab Emirates, among others. EMD Serono is currently seeking its approval in the United States.
“Merck is committed to deepening our understanding of the benefit-risk profile of this innovative MS treatment in patient populations with a high need for an effective disease-modifying therapy,” said Luciano Rossetti, head of global research and development for the biopharma business of Merck.
“Merck is committed to deepening our understanding of the benefit-risk profile of this innovative MS treatment in patient populations with a high need for an effective disease-modifying therapy.”
How about stopping this like HSCT for many? Or am I asking too much?
Here’s a list of the insurers (some of many). I am sending this to get the word out. The sooner the best.
Blue Cross & Blue Shield of Michigan (PPO) thru the ‘Obamacare’ exchange – Silver Multi-state plans approved 2014
NGS Cofinity (contract with Optum) approved 2014
United Healthcare – PPO approved 2014
Aetna approved 2014
Aetna approved 2014
Cigna approved 2014
Blue Cross & Blue Shield of Michigan approved 2014
Cigna approved 2014
HealthLink (state of Illinois employees) approved 2014
Harvard Pilgrim PPO approved 2014
Cigna approved 2014
SelectHealth approved 2014
Aetna approved 2014
BlueShield of CA – High Option PPO approved 2014
United Healthcare approved 2014
Blue Cross & Blue Shield of Michigan approved 2014
United Healthcare Choice approved 2014
Select Health Care plus approved 2014
Blue Cross & Blue Shield of Michigan approved 2015
Community Care Oklahoma – PPO Select approved 2015
CareFirst Blue ShieldBlue Cross Blue Shield ”Blue Preferred” approved 2015
Here’s just a few more:
BCBS of Illinois approved 2013
State of Texas overturned BCBS of Texas denial 2013
PHCS United Health Group denial was overturned by independent review 2013
Blue Cross Blue Shield Federal Employee Plan approved 2013
BCBS of Oregon approved 2013
Aetna approved 2013
Blue Cross & Blue Shield of Kansas City approved 2013
Medicare/Medical Mutual of Ohio approved 2013
HealthAlliance (state of Illinois plan) approved 2013
Humana approved 2014
United Healthcare approved 2014
Tricare Standard North Region (Health Net Federal) approved 2014
Blue Cross & Blue Shield of Alabama approved 2014
Cigna approved 2014
Keystone Health Plan East Blue Cross/Blue Shield of PA approved 2014
Aetna Open Access approved 2014
BCBS Federal Employee Program – Basic approved 2014
United Healthcare approved 2014
BCBS Federal Employee Program – Standard Plan approved 2014
Aetna approved 2012
United Healthcare approved 2012
Cigna approved 2012
BCBS Regence approved 2012
Health Alliance approved 2012
Blue Cross & Blue Shield of North Carolina approved 2012
Optum Health approved 2012
Wellmark of South Dakota approved 2012
BCBS Federal Program approved 2012
Anthem Blue Cross Blue Shield of Maryland approved 2012
Kaiser Southern California approved 2012
CA Anthem Blue Cross – PPO approved 2013
Anthem Blue Cross approved 2013
State of Illinois approved 2013
State of Illinois approved 2013
State of Illinois approved 2013
BCBS Federal Program approved 2013
Care First BCBS approved 2013
Cigna approved 2013
Humana Military approved 2013
BCBS Regence approved 2013
Anthem BCBS approved 2013
These are just a few.
“#AAN2018 – Blood Stem Cell Transplant Superior to DMDs in Highly Active RRMS, MIST Trial Shows”
Why are we still using drugs?
Hey Jason – I see you commenting on several of these articles with mentions of HSCT. What is your connection, if I may ask? Are you a patient, a rep for a clinic, a healthcare provider? I’m very interested in learning more about HSCT. I’d like to know who’s providing the information. Thanks.
A patient.
Here’s a solution, not sitting HSCT since 2009:
http://indianexpress.com/article/lifestyle/health/stem-cell-transplants-show-promise-for-multiple-sclerosis/
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