Sheetal Desai, MD, AWARE investigator and assistant clinical professor of medicine at UC Irvine, discusses full 52-week results of study comparing 2 popular rheumatoid arthritis patients and what the observed safety profile means from a patient-centered perspective.
The full 52-week results of the ongoing phase 4 AWARE trial examining comparing golimumab (Simponi Aria) and infliximab (Remicade) showcased noninferior efficacy for decreasing disease activity in rheumatoid arthritis, but also revealed an increase in infusion reactions among patients receiving infliximab.
With a primary endpoint of the proportion of patients experiencing an infusion reaction through week 52, investigators noted 12.7% in the 585 patients in the infliximab group experienced an infusion reaction compared to just 3.8% of the 685 patients receiving golimumab at 52 weeks.
The trial, which involved 1270 patients from 88 centers in the United States, was presented at Clinical Congress of Rheumatology (CCR) West 2019 annual meeting in San Diego, CA. The ongoing, prospective, non-interventional, observational 3-year study also had secondary endpoints of change in clinical disease activity index(CDAI) from baseline to 6 months and change from baseline to 12 months.
While rates of discontinuation were similar between groups, the rate of patients who discontinued due to an adverse event and cited an infusion reaction as the primary reason discontinuation from an infusion reaction was more than 3 times higher in the infliximab group. Infusion reactions made up 35.1% of the adverse events which caused discontinuation of infliximab compared to just 9.7% in the golimumab group—this was despite both groups having similar baseline characteristics.
Often times when applying clinical trial results to real-world practice, the patient perspective on safety is pushed to the wayside when choosing between 2 potential treatments. For more on how trial investigators hope to see the differences observed in infusion reactions and the safety profile of the popular rheumatoid arthritis treatments, MD Magazine® sat down with Sheetal Desai, MD, an assistant clinical professor of medicine at University of California, Irvine, after presenting results at CCR West.
MD Mag: The patients’ perspective is often overlooked in trial data, what does the decrease in infusion reactions mean in a real-world setting?
Desai: So, you know, I would say I'm guilty of this as we well. So, I'm in academia and we don't directly infuse our own patients like people in private practice and clinical practices do. Often, I don't see what happens when people get an infusion reaction and unless they tell me I may or may not even know. So, it's so important like you said from a patient perspective to be aware how patients view medications and if they have infusion reactions I can't remember the exact number, but I think it was 30-something percent of patients that were in the Remicade group wanted to switch out of the Remicade group because of infusion reactions.
So, I think much to what you said—physicians unless they're in a setting where they see the infusion and they see what happens to the patients—we may not realize the toll that an infusion reaction has on patients and looking at a real-world database, a lot of patients wanted to switch off of a drug that had an infusion reaction. Much to what you're saying that a patient doesn't want to take something to better themselves it's going to actually worsen some other component of their health. I think this study brings it out even more how the patient characteristics and the way they viewed these medicines really affected their ability to stay on the medicine or come off of it.