A clinical study conducted by the maker of Actemra (tocilizumab), comparing the drug to its competitor, Enbrel (Etanercept), strongly indicates that a warning on the Actemra Label related to congestive heart failure is warranted.
In the study (see below) Hoffman La Roche compared Actemra to Enbrel. The goal of the study was to demonstrate that Actemra was not inferior to Enbrel.
The study demonstrated that patients using Enbrel suffered less adverse events in general however, for the purpose of this article one particular adverse event caught our attention. The Hoffmann-La Roche study demonstrated that patients taking Actemra experienced congestive heart failure at essentially the same rate as those taking Enbrel with a statistically insignificant difference. One should also take into account that Hoffman-La Roche or those in their employ designed the rules of this “contest” as well as served as “referee”.
Whats the big deal?
The study conclusions become significant upon a review of the Black Box Warnings and Warnings and Precautions sections of Actemra and Enbrels FDA approved labels. Enbrel warns of Congestive Hearth Failure risks in the Warnings and Precautions section of their warning label and Acterma does not. Given the fact that Hoffman La-Roache took it upon themselves to stage this contest against Enbrel (with no input from the makers of Enbrel) and in the process discovered that their product carried essentially the same risk of Congestive Heart Failure (CHF) as Enbrel, Hoffman La-Roache would need to add the same warning related CHF in order not to be inferior to Enbrel.
Reasonably, if two competing drugs put patients at essentially the same risk of an AE and one drug warns potential users related to that AE and the other drug does not, the drug that does not warn is inferior. Given Hoffman La-Roache purpose was to prove non-inferiority to Enbrel, it would seem they may have achieved the opposite. Can theActemra Label be considered truthful and non misleading without a congestive heart failure warning given these facts or are they gaining an unfair advantage over Enbrel by withholding information from their warnings?
From out observations, it would appear that the study demonstrated higher risks for Actemra in most of the cardiac events observed. CHF caught our attention because Enbrel warns and Actemra does not.
Other important observations arose from the research conducted by Mass Tort Nexus specific to the study as well as the differences in the two product labels. Other observations will be covered in separate articles.
See the Black Box and Warnings and Precautions sections of the labels for both drugs below. We believe these to be the most current versions.