New Tool Offers Side-by-Side Comparison of RA Medications
New Tool Compares Benefits and Side Effects of RA Medications
Deciding on a new rheumatoid arthritis (RA) medication contains a lot of guesswork. We have more treatment options than ever before, but no effective way of comparing them. How do you decide which medication to take? A new tool called G-PROM holds promise for enabling doctors and their patients to truly compare medication benefits and side effects based on the real-life experience of other people who have taken that drug.
An information gap
When you look at different medication options, it’s natural to want to know how people do on one versus the other. “We don’t really have the data for that because currently randomized, controlled trials publish results separately from benefits and side effects,” said Liana Fraenkel, M.D., professor of medicine, Yale School of Medicine and section chief of rheumatology, Connecticut Healthcare System in a telephone interview. Dr. Fraenkel presented the study at the 2018 meeting of the American College of Rheumatology in Chicago.
What do we need?
“We wanted to think about a way where … people could predict ‘what’s my life going to be like?’ when you include all the possible effects of the drug — both benefits and side effects of one drug compared to the other,” Dr. Fraenkel said. Developing a tool to do just that was a major undertaking. Using data from the research registry of the ArthritisPower app created by CreakyJoints, an in-depth study was created.
First, Dr. Fraenkel and her team asked people with RA how they felt with certain side effects and certain benefits. They then created descriptions of side effects that occurred during randomized controlled trials of RA drugs. Another survey developed a “rank ordering [of side effects] for the least impact on your quality of life, all the way down to the most impactful.” As well, the team determined which side effects were equivalent. It was a challenging job, but once completed, yet another survey was done to pair side effects with different levels of benefits.
A global outcome tool
Each step in the process built on the previous, using trajectory mapping to finally develop a hierarchy that ranks different levels of benefits and side effects in combination. “There are five levels, ranging from the absolute best to the absolute worst,” Dr. Fraenkel explained. This is called the Global Patient-Reported Outcome Measure or G-PROM.
Validating the results
Part of any research is validating your results. That is, showing that you can get the same results in another population of study participants. Eventually, G-PROM will allow these randomized controlled trials to report results comparing benefits and side effects. Ultimately, this will enable rheumatologists and their patients to make better treatment decisions, improving quality of life for people with RA. Dr. Fraenkel and her team are continuing to validate the tool.
I asked Dr. Fraenkel if there were any surprises in the research. She explained that once a benefit was added, participants “lumped together everything from no side effects to manageable side effects in one group. It looks like as long as the side effects are mild to manageable, that’s fine.” She continued “no side effects didn’t have the magic cachet that I thought it would. They grouped [side effects] into manageable versus more serious, but not dreaded or terrible, versus terrible.”
One of the limitations of the study is that it used data from volunteers. “I don’t think we are ever going to be able to not do that, because you can’t just randomly sample thousands of people,” Dr. Fraenkel said. As well, the study looked only at a one side effect, but people may have multiple side effects. “If you have three side effects, does that equal one bad side effect? We don’t know,” Dr. Fraenkel said. “If people need that kind of information, we have to think about another way to include that.”
An educated guess
The G-PROM tool will allow you and your doctor to make a more educated guess about your experience on one drug or another. G-PROM gives people with RA “a better idea of what life was like on that medication for the people who took it compared to a different drug,” Dr. Fraenkel said.
One of the most common worries about taking medication for RA is the risk of side effects and their potential severity. The G-PROM will help you make a more informed decision by placing the benefit and side effects side-by-side, allowing you to balance one against the other. By giving you evidence of the quality of life experienced by other people on that medication, it becomes easier to make decisions without the fear.
Not a crystal ball
Dr. Fraenkel explained that the G-PROM isn’t perfect. “It can never predict for [patients] personally exactly what’s going to happen to them.” Nor is it designed to do so. This tool pulls together information about effects in people who have already taken the medication and removes a lot of the guesswork from making a decision. This makes the G-PROM a powerful tool in research and in your life in the future. It still needs to be tested and validated before it can be used in practice.