Alternative methods for analysis of radiographic damage in a randomized, double blind, parallel group clinical trial comparing hydroxychloroquine and sulfasalazine.

Abstract

Radiographic data of a 48-week double-blind, randomized, parallel trial comparing hydroxychloroquine (HCQ) and sulfasalazine (SASP) and its open label extension to 3 years of follow-up are analyzed in various ways. The focus of the paper is the methodological issues involved in analyses of radiographic data in a trial. Both the traditional method of increase in erosions and total score calculated on a group level, as well as individual progression on a patient level are presented. Regardless of which method is used, there is a statistically significant reduction in radiographic progression in the SASP group compared to the HCQ group.