Need for MRI confirmation seen
The potential problem with this new analysis as well as the previous analysis is the absence of MRI to provide objective evidence of axial involvement, according to Walter P. Maksymowych, MD, professor in the division of rheumatology at the University of Alberta, Edmonton.
Dr. Walter P. Maksymowych
Noting that previous studies have indicated that axial involvement assessed by investigators is not reliable even when performed with x-rays, Dr. Maksymowych said these data would be much more reassuring with MRI controls.
“We have seen little correlation between clinical symptoms and MRI manifestations of disease,” he said.
Dr. Gladman conceded this point. Baseline MRI was performed in some of the patients in this subgroup analysis, but it was not mandated. As a result, the data support benefit from guselkumab for symptomatic axial involvement, but she indicated that better evidence of a disease-modifying effect is expected from a more rigorous placebo-controlled trial of guselkumab called STAR.
This trial is requiring MRI at baseline and at week 24 and is using the Spondyloarthritis Research Consortium of Canada (SPARCC) score to assess change. Dr. Gladman said the trial is enrolling “as we speak.”
Overall, Dr. Gladman agreed with Dr. Maksymowych that objective biomarkers are important for demonstrating that treatments are improving long-term outcomes, not just relieving symptoms.
Guselkumab manufacturer Janssen supported the post hoc analysis. Dr. Gladman reported financial relationships with AbbVie, Amgen, Bristol-Myers Squibb, Eli Lilly, Galapagos, Gilead Janssen, Novartis, Pfizer, and UCB. Dr. Maksymowych reported financial relationships with AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, and UCB.