Sheetal Desai, MD, a rheumatologist and investigator of the ongoing AWARE trial, discusses her clinical takeaways from the 52-week results and the importance of real-world evidence.
The full data set of 52-week results from the ongoing AWARE trial are offering clinicians new insight into the effects of 2 of the most commonly prescribed rheumatoid arthritis treatments.
Results of the AWARE trial, which compares infliximab and golimumab, were presented at the Congress of Clinical Rheumatology (CCR) West 2019 annual meeting in San Diego, CA and expound the well of knowledge for both treatments.
Despite displaying noninferior efficacy and being used in patient groups that were similar in terms of characteristics and traits, investigators found patients in the golimumab group were less likely than their counterparts receiving infliximab to experience an infusion reaction. Specifically, investigators noted 12.7% of the 585 patients in the infliximab group experienced an infusion reaction compared to just 3.8% of the 685 patients receiving golimumab.
Additionally, reactions in the infliximab group continued through the infusion 9 of the trial, which investigators noted took place around the 52-week mark of the 3-year study. Investigators also pointed out there was an increase in use of pre-infusion meds in the infliximab group compared to the golimumab group (83.6% and 31.2% of patients, respectively).
To learn more about the results of the trial, MD Magazine® caught up with study investigator Sheetal Desai, MD, to get what she sees as the most impactful takeaways from the updated data set that was presented at CCR West.
MD Mag: What are your clinical takeaways from the full 52-week data set of AWARE?
Desai: So, I would take you back a little bit—from just clinical takeaways to the importance of real-world evidence. I think that's the biggest thing when I ask the audience do they know anything about real-world evidence most people don't.
Everyone is used to randomized, clinical, controlled trials, but I think in this era we need to have data, whether it's observational or not, on how patients fare on our medications any medications we use in a real-world setting as opposed to in an artificial setting where everything is controlled.
So, in this 52-week analysis looking at simponi aria versus remicade the beauty was is that they're both very efficacious, very equally efficacious in many ways. So, efficacy wasn't an issue at all. Infusion reactions much higher with remicade than with simponi aria but we're aware of that from the package insert—but it was nice to see that even in patients who had failed multiple biologics they still got clinical efficacy with simponi aria or remicade.