Jack Stacy, MSIV, of University of North Dakota, discusses a study he co-authored and presented at CCR West examining the use of low-dose prednisone to induce remission in patients with rheumatoid arthritis.
There are few chronic conditions that impact the wide range and sheer amount of patients as rheumatoid arthritis.
Without a cure, clinicians are constantly seeking new data and inventive ways to induce remission and decrease the sometimes debilitating impact of flare ups, but some treatments carry too high of a cost burden for many patients.
A study presented at the Clinical Congress of Rheumatology (CCR) West 2019 annual meeting in San Diego tackled this very issue. With the costs of some DMARDS exceeding $25,000 per year, investigators from the University of North Dakota sought to determine whether a low-dose glucocorticoid could induce remission without putting the patient at danger of serious adverse events.
Through comparisons of change in DAS28-ESR score, disease severity, and EULAR response, investigators sought to determine the efficacy of prednisone monotherapy in doses of less than 10 mg per day in patients with newly diagnosed rheumatoid arthritis.
At the conclusion of the study, investigators found more than 50% of patients were in remission and 70% had a good response according to EULAR response criteria. Additionally, investigators noted a decrease in adverse events compared to high-dose prednisone.
After presenting, Jack Stacy, MSIV, a medical student at the University of North Dakota, sat down to discuss the results of the study and their clinical impact.
MD Mag: Can you describe the results of your study examining use of low-dose prednisone to induce remission in patients with rheumatoid arthritis?
Stacy: So, glucocorticoids have been used in RA since 1949. The use has sort of trended down a little bit in the last few decades with the onset of these of synthetic DMARDS and biologics. These DMARDs and biologics though are quite expensive. So, Remicade, one of the older biologics, the yearly drug cost alone is $25,000 to $46,000. So, me and my colleagues, we were looking into getting back on the glucocorticoid train, so to speak. Right now, glucocorticoids are used to as bridging therapy at the beginning of the disease trajectory, while getting onto the DMARD or a biologic, and they're also used in the event of a flare up of the disease.
However, they're dosed at higher doses, so Medrol dose packs or things like that, starting at 40 to 60 milligrams a day. What we're looking into is trying to use lower dose prednisone to induce remission. The first thing that comes to everybody's mind when you talk about glucocorticoids is the side effect profile that comes along with them. But the side effects are more prominent with the higher doses.
So, that's why we were looking into lower doses. We did a chart review—almost 1400 patients were screened and we had 201 that met our inclusion and exclusion criteria. Patients were included if they were newly diagnosed with RA and if they were treated with 10 milligrams or less of prednisone a day. They were excluded if they'd ever been treated with a DMARD, if they had been treated with prednisone by a primary care provider before the referral to our service, and they are also excluded, obviously, if they didn't have sufficient data to measure our outcomes.
The outcomes that we're looking at were disease severity prior to treatment and after treatment. So we use the DAS28 ESR score to assess the disease severity and we also looked at the EULAR response criteria, which takes into account both the final DAS score after treatment as well as the improvement in the DAS score. So, we found that we had significant improvement in all four components of the DAS score which are taken into account. Sed rate are we're using the desk 28 ESR. So it takes into account sed rate, tender joint count, swollen joint counts, as well as visual analog pain scale on a scale of 1 to 10.
So, unsurprisingly, we also saw significant improvement in the DAS score overall, with an initial average score of 5.1 and improvement all the way to 2.7. We also categorized our patients based on the DAS score as either in remission, low disease severity, moderate disease severity, and severe severity. At presentation, 95% of our patients were in the moderate to severe category, and after treatment 5% remained in the severe category while 54.2% had reached remission.
Finally, the using the EULAR response criteria, 69.7% of our patients had showed a good response. So, I briefly touched on the cost and that's one of the significant findings that was one of the reasons we think these findings are significant. If we can hold off on biologics, even for a little while, and replace them with the very inexpensive global quarter codes for that period of time—we could potentially save quite a bit of money when it comes to RA treatments, but I think the more significant and more exciting aspect to our findings is that we're using low-dose prednisone as opposed to high-dose prednisone.
So, I talked about the adverse effects of glucocorticoids a little bit before. We know that the long term adverse effects are related to the cumulative lifelong dose that a patient gets. So, if we can, instead of treating patients with flares with high-dose prednisone every time and we can treat them with low-dose prednisone instead, we can theoretically decrease their lifelong exposure to will glucocorticoids and then therefore decrease their risks for adverse effects as well.