52-Week AWARE Results Show Efficacy, Safety of Rheumatoid Arthritis Therapies
September 30, 2019
For some popular treatments, rheumatologists rely solely on clinical trial data for guidance, which some feel can fail to paint the whole picture about how a treatment works in a real-world population.
AWARE, which is an ongoing 3-year study, is designed as a prospective, non-interventional, observational, multi center ongoing Phase 4 trial comparing the popular treatments in 88 centers in the United States. With the primary endpoint being the proportion of patients experiencing an infusion reaction through week 52 and secondary endpoints of change in clinical disease activity index(CDAI) from baseline to 6 months and change from baseline to 12 months, results paint a clearer picture of how certain populations may react to either treatment.
The total study population of AWARE was 1270 patients and while interim 52-week data of AWARE had been presented previously, Aaron Broadwell, MD, presenter and rheumatologist with Rheumatology and Osteoporosis Specialists in Shreveport, LA, noted it did not include data on the entire study population as not all patients had been enrolled for an entire year.
AWARE results revealed 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. Reactions did not occur in the golimumab group after infusion 4, but continued through infusion 9 of the trial in the infliximab group. Investigators noted infusion 9 took place around the 52-week mark of the ongoing 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). Broadwell took time during the presentation of trial results to reference the finding that one-third of patients in the trial were not taking methotrexate.
For Broadwell, AWARE investigator and a clinician whose practice includes an infusion center, the results represent tangible evidence that can be applied in clinical practice. After presenting the results of AWARE at CCR West, Broadwell sat down with MD Magazine® to share his interpretation of the full 52-week data set from the viewpoint of a study investigator and someone who will use the results in a real-world setting.
What added value does AWARE’s real-world data give you that clinical trial data does not?
Broadwell: So, every time we look at phase 3 trials we're going to screen out all our patients with any type of malignancy history—any congestive heart failure or anything else—that is an exclusion criteria. With this very limited set of exclusion criteria, we can say that patients that match our own patients.
I mean, to the point where these are all US sites these are primarily non-academic centers that are actually used. So, for us in private practice especially, but really for all us rheumatologists this matches our patient population and you didn't see any major signals coming out of it. We didn't see any major malignancy issues or other adverse events that came out of this very heterogeneous patient population.
MD Mag: How do you interpret the one-third of patients who were not taking concomitant methotrexate?
Broadwell: So, I find that it's very interesting, since this is a real world population where one-third of patients—approximately—in each group were not on methotrexate and, as we all know, both simponi aria and remicade are indicated to be used with methotrexate for active rheumatoid arthritis.
So, number 1, I think this is something that we see happening in the clinics all the time. There are many patients who are not appropriate for methotrexate due to many different reasons and we don't really know how it performs inside of a trial and in these subsets we didn't see any major differences as far as effectiveness whether or not they were taking or not taking methotrexate. It's very reassuring for that, for groups of patients who shouldn't take methotrexate, can't tolerate it, etc., that these are still both very good options for them.
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