Conference Coverage
Dr. Dafna A. Gladman of the University of Toronto shared some of Dr. Louie’s skepticism of the primary endpoint, but credits the investigators with creating a measure that appears to have “construct validity, as well as sensitivity to change.”
In Dr. Gladman’s editorial (Arthritis Rheumatol. 2014 Dec. 29 [doi:10.1002/art.39014]), she noted that “the development of the measure is not described. Was it developed through a Delphi process? Has it shown face and construct validity in peripheral SpA? Has it shown test retest reliability? What we do know is that this measure distinguished between drug and placebo treated patients, [that] the majority of the response was related to the patient reported outcome which was a prerequisite and to the joint count item, [and] that the individual measures tested in this study showed the same results. One could then conclude that the new measure has construct validity, as well as sensitivity to change and thus would be acceptable as the primary outcome measure in this study.”
The ABILITY-2 study was funded by AbbVie, which markets adalimumab. Two authors are employees of the company. All other authors reported receiving grant/research support, consulting fees, and/or speaking fees from AbbVie and other companies that market biologics.
