Value of alemtuzumab demonstrated in RRMS patients with prior IFNB-1a treatment

 

LOS ANGELES – Patients with multiple sclerosis in the CARE-MS II study who switched from interferon beta-1a therapy to the humanized monoclonal antibody alemtuzumab experienced continued reductions in brain volume loss and lesions on MRI through 5 years, according to follow-up data from the CARE-MS II extension study known as TOPAZ.

These outcomes support core findings from the CARE-MS II study, and suggest that alemtuzumab (Lemtrada) provides a unique treatment approach for patients with prior subcutaneous interferon beta-1a (IFNB-1a) treatment, Daniel Pelletier, MD, reported in a poster discussion session at the annual meeting of the American Academy of Neurology.

In CARE-MS II, relapsing-remitting multiple sclerosis patients with inadequate response to prior therapy experienced improvements in MRI lesions and brain volume loss with two courses of alemtuzumab versus IFNB-1a through 2 years, and in a 4-year extension in which participants discontinued subcutaneous IFNB-1a and initiated alemtuzumab at 12 mg/day, they experienced durable efficacy in the absence of continuous treatment, explained Dr. Pelletier, a professor of neurology at the University of Southern California, Los Angeles.

In the extension, patients could receive alemtuzumab retreatment as needed for relapse/MRI activity or receive other disease-modifying therapies at the investigator’s discretion. Patients completing the extension could enter the 5-year TOPAZ study for further evaluation, he said.

Of 119 patients who completed TOPAZ year 1, and thus had 5 years of follow-up after initiating alemtuzumab, 78% were free of new, gadolinium-enhancing lesions in IFNB-1a year 2; this increased significantly to 92% in post-alemtuzumab year 2, and remained high at 85%-89% in years 3-5. Additionally, 48% of patients were free of new/enlarging T2 lesions in IFNB-1a year 2; this increased significantly to 81% in post-alemtuzumab year 2 and remained high in years 3-5.

Further, 47% of the TOPAZ patients were MRI disease activity–free in IFNB-1a year 2; this increased significantly to 81% in post-alemtuzumab year 2, and remained high at 67%-72% in years 3-5.

 

“Perhaps for me what makes even more sense is looking at the yearly brain parenchymal fraction change,” Dr. Pelletier said, noting that the median annual reductions in years 1-5, respectively, were 0.02%, 0.04%, 0.15%, 0.14%, and 0.08%, compared with –0.33% for subcutaneous IFNB-1a at year 2 in CARE-MS II. The median brain parenchymal fraction change from baseline to post-alemtuzumab year 5 was –1.40%.

In 61% of patients, no further treatment was given after the second course of alemtuzumab.

The findings suggest that alemtuzumab provides durable efficacy without continuous treatment, he concluded.

This study was supported by Sanofi and Bayer Healthcare Pharmaceuticals. Dr. Pelletier has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Merck Serono, Novartis, Roche, and Sanofi, as well as research support from Biogen, Merck Serono, Novartis, Roche, and Sanofi.

[email protected]

SOURCE: Pelletier D et al. Neurology. 2018 Apr 10. 90(15 Suppl.):P5.031.

 

LOS ANGELES – Patients with multiple sclerosis in the CARE-MS II study who switched from interferon beta-1a therapy to the humanized monoclonal antibody alemtuzumab experienced continued reductions in brain volume loss and lesions on MRI through 5 years, according to follow-up data from the CARE-MS II extension study known as TOPAZ.

These outcomes support core findings from the CARE-MS II study, and suggest that alemtuzumab (Lemtrada) provides a unique treatment approach for patients with prior subcutaneous interferon beta-1a (IFNB-1a) treatment, Daniel Pelletier, MD, reported in a poster discussion session at the annual meeting of the American Academy of Neurology.

In CARE-MS II, relapsing-remitting multiple sclerosis patients with inadequate response to prior therapy experienced improvements in MRI lesions and brain volume loss with two courses of alemtuzumab versus IFNB-1a through 2 years, and in a 4-year extension in which participants discontinued subcutaneous IFNB-1a and initiated alemtuzumab at 12 mg/day, they experienced durable efficacy in the absence of continuous treatment, explained Dr. Pelletier, a professor of neurology at the University of Southern California, Los Angeles.

In the extension, patients could receive alemtuzumab retreatment as needed for relapse/MRI activity or receive other disease-modifying therapies at the investigator’s discretion. Patients completing the extension could enter the 5-year TOPAZ study for further evaluation, he said.

Of 119 patients who completed TOPAZ year 1, and thus had 5 years of follow-up after initiating alemtuzumab, 78% were free of new, gadolinium-enhancing lesions in IFNB-1a year 2; this increased significantly to 92% in post-alemtuzumab year 2, and remained high at 85%-89% in years 3-5. Additionally, 48% of patients were free of new/enlarging T2 lesions in IFNB-1a year 2; this increased significantly to 81% in post-alemtuzumab year 2 and remained high in years 3-5.

Further, 47% of the TOPAZ patients were MRI disease activity–free in IFNB-1a year 2; this increased significantly to 81% in post-alemtuzumab year 2, and remained high at 67%-72% in years 3-5.

 

“Perhaps for me what makes even more sense is looking at the yearly brain parenchymal fraction change,” Dr. Pelletier said, noting that the median annual reductions in years 1-5, respectively, were 0.02%, 0.04%, 0.15%, 0.14%, and 0.08%, compared with –0.33% for subcutaneous IFNB-1a at year 2 in CARE-MS II. The median brain parenchymal fraction change from baseline to post-alemtuzumab year 5 was –1.40%.

In 61% of patients, no further treatment was given after the second course of alemtuzumab.

The findings suggest that alemtuzumab provides durable efficacy without continuous treatment, he concluded.

This study was supported by Sanofi and Bayer Healthcare Pharmaceuticals. Dr. Pelletier has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Merck Serono, Novartis, Roche, and Sanofi, as well as research support from Biogen, Merck Serono, Novartis, Roche, and Sanofi.

[email protected]

SOURCE: Pelletier D et al. Neurology. 2018 Apr 10. 90(15 Suppl.):P5.031.

 

LOS ANGELES – Patients with multiple sclerosis in the CARE-MS II study who switched from interferon beta-1a therapy to the humanized monoclonal antibody alemtuzumab experienced continued reductions in brain volume loss and lesions on MRI through 5 years, according to follow-up data from the CARE-MS II extension study known as TOPAZ.

These outcomes support core findings from the CARE-MS II study, and suggest that alemtuzumab (Lemtrada) provides a unique treatment approach for patients with prior subcutaneous interferon beta-1a (IFNB-1a) treatment, Daniel Pelletier, MD, reported in a poster discussion session at the annual meeting of the American Academy of Neurology.

In CARE-MS II, relapsing-remitting multiple sclerosis patients with inadequate response to prior therapy experienced improvements in MRI lesions and brain volume loss with two courses of alemtuzumab versus IFNB-1a through 2 years, and in a 4-year extension in which participants discontinued subcutaneous IFNB-1a and initiated alemtuzumab at 12 mg/day, they experienced durable efficacy in the absence of continuous treatment, explained Dr. Pelletier, a professor of neurology at the University of Southern California, Los Angeles.

In the extension, patients could receive alemtuzumab retreatment as needed for relapse/MRI activity or receive other disease-modifying therapies at the investigator’s discretion. Patients completing the extension could enter the 5-year TOPAZ study for further evaluation, he said.

Of 119 patients who completed TOPAZ year 1, and thus had 5 years of follow-up after initiating alemtuzumab, 78% were free of new, gadolinium-enhancing lesions in IFNB-1a year 2; this increased significantly to 92% in post-alemtuzumab year 2, and remained high at 85%-89% in years 3-5. Additionally, 48% of patients were free of new/enlarging T2 lesions in IFNB-1a year 2; this increased significantly to 81% in post-alemtuzumab year 2 and remained high in years 3-5.

Further, 47% of the TOPAZ patients were MRI disease activity–free in IFNB-1a year 2; this increased significantly to 81% in post-alemtuzumab year 2, and remained high at 67%-72% in years 3-5.

 

“Perhaps for me what makes even more sense is looking at the yearly brain parenchymal fraction change,” Dr. Pelletier said, noting that the median annual reductions in years 1-5, respectively, were 0.02%, 0.04%, 0.15%, 0.14%, and 0.08%, compared with –0.33% for subcutaneous IFNB-1a at year 2 in CARE-MS II. The median brain parenchymal fraction change from baseline to post-alemtuzumab year 5 was –1.40%.

In 61% of patients, no further treatment was given after the second course of alemtuzumab.

The findings suggest that alemtuzumab provides durable efficacy without continuous treatment, he concluded.

This study was supported by Sanofi and Bayer Healthcare Pharmaceuticals. Dr. Pelletier has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Biogen, Merck Serono, Novartis, Roche, and Sanofi, as well as research support from Biogen, Merck Serono, Novartis, Roche, and Sanofi.

[email protected]

SOURCE: Pelletier D et al. Neurology. 2018 Apr 10. 90(15 Suppl.):P5.031.