Natalizumab May Modulate Clinical Disease Activity in Patients With Multiple Sclerosis: Presented at WCTRMS

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Title: Natalizumab May Modulate Clinical Disease Activity in Patients With Multiple Sclerosis: Presented at WCTRMS
URL: http://www.pslgroup.com/dg/22D70A.htm
Doctor's Guide
September 24, 2008

By Danny Kucharsky

MONTREAL -- September 24, 2008 -- Patients with relapsing multiple sclerosis (MS) who are treated with natalizumab derive marked clinical benefits despite the presence of gadolinium-enhancing (Gd+) lesions, according to a study presented here at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRMS).

David Bates, MD, Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom, presented the study here on September 18.

The study aimed to determine relapse activity in patients who had at least 1 Gd+ lesion over 2 years of natalizumab treatment in 2 phase 3 studies: the Natalizumab Safety and Efficacy in Relapsing Remitting Multiple Sclerosis (AFFIRM) study and the Safety and Efficacy of Natalizumab in Combination With Interferon Beta-1a in Patients With Relapsing Remitting Multiple Sclerosis (SENTINEL) study.

The AFFIRM study treated 627 patients with natalizumab and 315 with placebo; SENTINEL treated 589 patients with interferon beta-1a plus natalizumab and 582 with interferon beta-1a plus placebo.

Dr. Bates noted that the majority of patients treated with natalizumab had no Gd+ lesions, but "it is important to evaluate the extent to which natalizumab improves clinical outcomes in patients who did have Gd+ lesions during treatment."

In AFFIRM, 5% of natalizumab patients and 43% of placebo patients had 1 or more Gd+ lesions over 2 years. In SENTINEL, 8% of 518 who completed treatment with natalizumab plus interferon beta-1a patients had 1 or more Gd+ lesions over 2 years. (The percentage of Gd+ lesions for placebo patients in SENTINEL over 2 years was not provided.)

Treatment with natalizumab in AFFIRM significantly increased the proportion of relapse-free patients over 2 years compared with placebo (60% vs 37%; P = .019). Exclusion of patients who developed persistent antibodies to natalizumab from the analysis resulted in a greater proportion of relapse-free patients among those treated with natalizumab (78% vs 37% for placebo; P < .001).

Treatment with natalizumab plus interferon beta-1a in SENTINEL patients significantly increased the proportion of relapse-free patients over 2 years compared with those receiving interferon beta-1a alone (51% vs 25%; P < .001). Once patients who developed persistent antibodies were excluded from the analysis, treatment with natalizumab plus interferon beta-1a resulted in an increased proportion of relapse-free patients compared with those receiving interferon beta-1a alone (64% vs 25%; P < .001).

Furthermore, treatment with natalizumab significantly decreased the annualised relapse rate by 58% over 2 years compared with placebo (0.28 vs 0.66; P = .004) in AFFIRM and by 45% over 2 years compared with interferon beta-1a alone (0.41 vs 0.74, respectively; P = .008) in SENTINEL.

Significantly more patients treated with natalizumab were relapse-free and had reduced annualised relapse rates compared with placebo, Dr. Bates noted.

Dr. Bates said the data reveal a potential for natalizumab to modulate clinical disease activity even in patients with Gd+ lesions on therapy.

"These results suggest that natalizumab may shift the course of disease activity to a less active or less severe state and may induce a state of remission," Dr. Bates concluded.

Funding for the study was provided by Biogen Idec and Elan Pharmaceuticals.

[Presentation title: Effect of Natalizumab on Relapses in Patients With Relapsing MS Who Experience MRI Activity During Treatment. Abstract P8]

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