Author Topic: (AAN) Interim analysis from Phase 3 ATTAIN study of Plegridy  (Read 196 times)

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Offline agate

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Drug-company sponsored but the adverse events record might be worth noting.

Presented at the recent annual AAN conference in Washington, DC:

Quote
[S4.002] Long-Term Safety and Tolerability of Peginterferon Beta-1a: Interim Analysis From ATTAIN, a Phase 3 Extension Study

Marcelo Kremenchutzky,1Shifang Liu,2Yue Cui,2Serena Hung,2Ali Seddighzadeh,2Vladimir Evilevitch2

1London, ON, Canada, 2Cambridge, MA, USA.

OBJECTIVE:

To investigate the long-term safety and tolerability of peginterferon beta-1a (PEG-IFN) in relapsing-remitting multiple sclerosis (RRMS).

BACKGROUND:

ATTAIN is a 2-year extension of the Phase 3 2-year ADVANCE study, and designed to evaluate long-term safety, tolerability, and disease outcomes of PEG-IFN. The following analysis examines PEG-IFN safety up to the interim cutoff date of August 1 2014.

DESIGN/METHODS:

RRMS patients aged 18-65 were assigned to either PEG-IFN dosed every 2 or 4 weeks, or delayed treatment (placebo for Year 1 followed by PEG-IFN every 2 or 4 weeks for Years 2 and 3). For analysis, subjects were grouped by PEG-IFN dose frequency (every 2 or 4 weeks); delayed treatment patients were included in these two dosing groups, beginning with their Year 2 data.

Primary endpoints evaluated were incidence of adverse events (AEs), serious AEs (SAEs), discontinuations due to AEs, and laboratory abnormalities.

RESULTS:

At cutoff, 88% of subjects had completed Year 1 of ATTAIN and begun Year 2 of ATTAIN. In both groups, 96% of patients experienced an AE overall (n=710/740, n=697/728, every 2 weeks and every 4 weeks, respectively).

In Year 3 of PEG-IFN treatment, 74% and 75% of patients experienced an AE (n=414/557, n=411/547, every 2 weeks and every 4 weeks, respectively).

Incidence of SAEs were 21% (n=157/740) and 28% (n=202/728) overall, and 7% (n=40/557) and 11% (n=58/547) in Year 3, every 2 weeks and every 4 weeks, respectively.

Incidence of discontinuations due to AEs were 8% (n=62/740) and 7% (n=54/728) overall, and 1% (n=8/557) and 1% (n=7/547) in Year 3, every 2 weeks and every 4 weeks, respectively. The most common AEs across doses and time-points were injection-site reactions and flu-like symptoms.

CONCLUSIONS:

In RRMS patients, long-term safety and tolerability of PEG-IFN remains favorable and similar to the ADVANCE safety and tolerability profile.

____________________
Study sponsored by: Biogen Idec Inc. (Cambridge, MA, USA).
Category - MS and CNS Inflammatory Disease: Clinical Science

Session: S4: Platform Session: Clinical Trial Outcomes in Multiple Sclerosis (1:00 PM-2:45 PM)
Date/Time: Tuesday, April 21, 2015 - 1:15 pm
 

The abstract can be seen here.
MS Speaks--online for 12 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.