Aaron Broadwell, MD: Updated 52-Week Data from AWARE Trial

While randomized, controlled clinical trials offer data into potential new treatments, they do not provide the same clinically impactful insights of real-world studies examining those same treatments.

Which is why the full 52-week data of the AWARE trial comparing infliximab(Remicade) and golimumab(Simponi Aria) has attracted the attention of many rheumatologists at the Congress of Clinical Rheumatology (CCR) West 2019 annual meeting in San Diego, CA.

The AWARE trial, which a prospective, non-interventional, observational, multi center ongoing Phase 4 study, is a 3-year study comparing the 2 popular treatments for rheumatoid arthritis—that are both produced by Janssen Pharmaceuticals. Conducted across 88 centers in the US, the trial contains 1270 patients.

The primary endpoint of the study is the proportion of patients with rheumatoid arthritis treated with either drug who experienced an infusion reaction through week 52. Secondary endpoints of the study included clinical disease activity index(CDAI) change from baseline to 6 months and CDAI change from baseline to 12 months.

Information on the 52-week data of AWARE had been presented previously, but presenters noted it did not include data on the entire study population as not all patients had been enrolled for an entire year. Results of the full data set revealed similar trends to the interim analysis, which revealed a lower rate of infusion reactions among patients in the golimumab group.

For a better understanding of the updated data, MD Magazine® sat down with Aaron Broadwell, MD, a rheumatologist with Rheumatology and Osteoporosis Specialists, after his presentation of the results.

MD Mag: Can you detail the new 52-week data from the AWARE trial presented at CCR West?

Broadwell: So, we got to go a little bit further than what we had previously in our interim analysis of AWARE, which was our head-to-head Remicade versus Simponi Aria real-world trial. We had previously presented data about superiority as far as fewer in fusion reactions in the Simponi Aria group than the Remicade group at an interim analysis.

Tonight, we got to go into the full 52-week data set once all patients had completed the 52 weeks or had discontinued and got to look at in fusion reactions compared there where you saw continued trends there were there were fewer in fusion reactions in the Simponi Aria group than the Remicade group.

Despite that, we saw very similar CDAI changes. So, clinical response over time was very similar and then adverse events we were also able to look at. We had more patients with discontinuation due to infusion reaction in the Remicade group versus more discontinuation due to lack of efficacy despite similar CDAI results in the Simponi Aria group.