Safety and efficacy of natalizumab in Belgian multiple sclerosis patients: subgroup analysis of the natalizumab observational program

Abstract

Natalizumab (Tysabri(®)) is highly efficacious in controlling disease activity in relapsing multiple sclerosis (MS) patients. As it is one of the more recent therapies for MS, there remains a need for long-term safety and efficacy data of natalizumab in a clinical practice setting. The Tysabri observational program (TOP) is an open-label, multicenter, multinational, prospective observational study, aiming to recruit up to 6,000 patients with relapsing-remitting MS from Europe, Canada and Australia. The objectives of this study are to collect long-term safety and efficacy data on disease activity and disability progression. We report here the interim results of the 563 patients included in TOP between December 2007 and 2012 from Belgium. This patient cohort was older at baseline, had longer disease duration, higher neurological impairment, and a higher baseline annualized relapse rate, when compared to patients included in the pivotal phase III AFFIRM trial. Nevertheless, the efficacy of natalizumab was comparable. The annualized relapse rate on treatment was reduced by 90.70 % (p < 0.0001) with a cumulative probability of relapse of 26.87 % at 24 months. The cumulative probabilities of sustained disability improvement and progression at 24 months were 25.68 and 9.01 %, respectively. There were no new safety concerns over the follow-up period. Two cases of progressive multifocal leukoencephalopathy were diagnosed. Our results are consistent with other observational studies in the post-marketing setting.

Real-world study of efficacy, risk management and reasons for discontinuation of natalizumab for treatment of multiple sclerosis in Russia

“…Patients on NTZ had a significant decrease of relapse rate after 2 years of therapy. The number of relapses during first and second years of therapy tended to 0, that corresponds with data from other studies [10, 11]. Similarly, MRI activity was almost completely suppressed, proving a strong efficacy of NTZ in highly-active patients [10, 11].…”

Ocrelizumab efficacy in subgroups of patients with relapsing multiple sclerosis

“…These findings are consistent with treatment benefit of other DMTs, which has previously been suggested to be higher in younger than in older patients on the basis of higher disease activity in younger populations with MS [ 5 ]. Subgroup analyses performed for other DMTs using either placebo or an active comparator, e.g., fingolimod [ 6 , 7 ], cladribine [ 8 ], teriflunomide [ 9 ], dimethyl fumarate [ 10 – 12 ], alemtuzumab [ 13 ], and natalizumab [ 14 , 15 ], also found that efficacy was highest in younger patients with more active disease.…”

Immunosuppressive Agents for the Treatment of Primary Sclerosing Cholangitis: A Systematic Review and Meta-Analysis

“…Autoimmunity has a strong association for PSC with IBD [1,30] . Various IAs such as corticosteroid [31,32] , infliximab [16] , natalizumab [33] , tacrolimus [34] , mycophenolate mofetil [15,35] , budesonide, and prednisolone [12,36,37] had been investigated. However, the clinical benefit and risk associated with the administration of IAs in PSC patients remain inconclusive.…”