SAN FRANCISCO, CA—Either the Stanford Health Assessment Questionnaire (HAQ) or the Center for Rheumatic Diseases HAQ (CRDHAQ) can be used to assess functional improvement in clinical trials conducted in the Indian rheumatoid arthritis (RA) population, reported Arvind Chopra, MD, from Center for Rheumatic Diseases, Rheumatology, Pune, India, at the 2015 ACR/ARHP Annual Meeting.
The Center for Rheumatic Diseases (CRD) in Pune, India developed a modified version of the Stanford HAQ, a questionnaire more relevant to RA patients in Western countries, to account for daily activities unique to India and other Asian countries, such as sitting cross-legged on the floor. Dr. Chopra and his team set out to compare the performance of both questionnaires in a clinical trial conducted in India.
The 54-week clinical trial included 189 Indian patients with RA for ≥2 years, who were randomly assigned to receive the reference infliximab (rIFX; n=62) or the biosimilar IFX BOW15 (n=127). The study included an initial double-blind phase for 16 weeks, followed by an open-label extension. All but eight patients (120 in the BOW15 group and 1 in the rIFX group) completed the blinded phase of the study.
Disability index (DI) scores from baseline for both questionnaires were compared.
Dr. Chopra and his team found that there were “no statistically significant differences between HAQ-DI and CRDHAQ-DI scores from baseline between treatments across each assessment period.” Both treatments in both HAQ and CRDHAQ showed statistically significant improvements in each score from baseline from Week 2 through 16 (P<0.001). “These decreases in DI by treatment corresponded to comparable increases in percent ACR20 responders observed at the time points,” he added.