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Joshua Solomon, MD, discusses his upcoming ACR presentation entitled, “A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease.”
Rheumatology Network interviewed Joshua Solomon, MD, to discuss his upcoming ACR presentation entitled, “A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study of Safety, Tolerability and Efficacy of Pirfenidone in Patients with Rheumatoid Arthritis Interstitial Lung Disease.” Solomon is Associate Professor of Medicine at National Jewish Health. He explains the TRAIL-1 study, clinical significance of the study results, and the association between rheumatoid arthritis (RA) lung disease and death.
Rheumatology Network: How does rheumatoid arthritis-associated interstitial lung disease lead to death in 10% of patients?
Joshua Solomon, MD: Interstitial lung disease in RA is common and it can progress. And so, in a subgroup of patients with RA and interstitial lung disease, they have progressive fibrosis in their lungs and they get progressive respiratory failure. Over time, their lung capacity diminishes, and it leads to their death. And so, it was a study in the past looked at the cause of death in patients with RA and up to 10% of the lung disease contributed. That's a significant number.
RN: Can you give me a bit more background on the TRIAL-1 study?
JS: TRIAL-1 is the first randomized placebo controlled trial looking exclusively at patients with RA and interstitial lung disease. We chose to look at a drug called pirfenidonem, which is an anti-fibrotic, because we know that pirfenidone actually has an effect in patients with idiopathic pulmonary fibrosis, which is a scarring lung disease that shares a lot of similarities with RA lung disease. And so, we chose that as a drug and we followed patients over time and wanted to see if it was safe and effective in the subgroup patient.
RN: And what were the results of that study?
JS: The study was terminated early because of slow recruitment that was exacerbated by the pandemic. We did not have power to meet our primary endpoint, which was a composite endpoint. But our secondary endpoints looking at change in lung function over time were met. And so, when people were on pirfenidone, there was a decline in the progression over time as measured by lung function. So you put people on pirfenidone with RA interstitial lung disease and it slows down the decline in their lung function over 52 weeks.
RN: What is the clinical significance of these results?
JS: Well, I think 2 things are significant. The most important thing that is significant from these results is that it's a safe and well-tolerated drug. So I think that's really the biggest take home. Patients with rheumatoid arthritis lung disease don't just have 1 disease, they have 2. So they're on drugs for their rheumatoid arthritis and there's always been a concern that putting people on anti-fibrotic drugs would you'd have drug interactions or just decreased tolerance but in this trial, patients tolerated it really well. It was safe and there were no new safety signals. And then we showed that it was effective and then it slowed down the rate of decline. So I think those are the 2 big take homes: it's safe and it's effective.
RN: What are you most excited about the upcoming ACR Convergence?
JS: I'm actually excited to just be a part of it. I've been working on rheumatoid arthritis lung disease for some time and I've had some abstracts in ACR, but actually being able to present the trail results in the in ACR is exciting. It's just a better way to put us together. The rheumatologist and pulmonologist, we have a close relationship, but the closer we can get, the better. We really share a lot of patients and just being able to interact with them in an academic setting is great. It's just a way for us to share ideas and develop future research projects. And these conferences are really a great way for us to just network. I can learn about the new research but really networking with a rheumatologist and forming projects and developing ideas. I think that's the most exciting thing for me.
RN: Is there anything else that you would like our audience to know before we wrap up?
JS: The lungs are a big deal in autoimmune disease and all of the connective tissue diseases can have lung manifestations. Some are worse than others, but I implore [rheumatologists] to be aware of these manifestations listen to their patient's lungs. If they you hear anything that's abnormal, get some imaging. If it's abnormal, let's involve a pulmonologist and let's work together on these patients.