Infliximab Better for Steroid Tapering in Cardiac Sarcoidosis
Therapy's steroid-sparing effects superior to methotrexate in small study
Infliximab — marketed as Remicade and biosimilars — had steroid-sparing effects superior to methotrexate in the treatment of cardiac sarcoidosis, a small study found.
The success rate of a tapering course of corticosteroids was significantly better when infliximab was added to the regimen than when the steroid was used alone or together with methotrexate.
The researchers said they believe their findings “add to the evidence supporting the usefulness of infliximab in the treatment of cardiac sarcoidosis,” despite limitations due to the study’s retrospective nature.
The study, “Outcomes of prednisone-tapering regimens for cardiac sarcoidosis: A retrospective analysis demonstrating a benefit of infliximab,” was published in the journal Respiratory Medicine.
Steroid-tapering therapies in cardiac sarcoiodsis
Broadly, sarcoidosis is marked by the formation of small clumps of inflammatory cells, called granulomas, in the body’s tissues. These granulomas disrupt normal organ function. When they form in the heart, it’s called cardiac sarcoidosis, and its hallmark symptoms include chest pain, shortness of breath, palpitations, and irregular heartbeat.
Cardiac sarcoidosis is reported in anywhere from 5% to up to 50% of systemic sarcoidosis patients.
While corticosteroids are a first-line treatment, these medications may come with significant side effects, such as weight gain and inability to fall asleep. Methotrexate, a type of cancer drug, has been recommended as a second-line medication that can help lower corticosteroid dose.
Meanwhile, infliximab has been shown to be effective for some cardiac sarcoidosis patients who did not respond to corticosteroid or corticosteroid-methotrexate treatment regimens. However, its corticosteroid-sparing effects have not been fully established.
In this study, a team of researchers further investigated the potential corticosteroid-sparing properties of methotrexate and infliximab when used in combination with prednisone, a standard steroid treatment.
A clinical sarcoidosis database was retrospectively reviewed to identify cases in which cardiac sarcoidosis patients were treated with prednisone either alone or in combination with one of the other two medications.
Prednisone was always administered in a tapering regimen, meaning the dose typically started with 30–40 mg per day and was reduced over time as long as the patient remained stable or improved. Notably, the exact tapering regimen was not standardized across patients.
In cases where prednisone was used with methotrexate, the oral therapy was given at a dose of 10–15 mg per week. When infliximab was used, it was administered as a 5 mg infusion per week at treatment start, two weeks later, six weeks later, and then every four to six weeks.
A total of 61 prednisone-tapering regimens across 33 patients were analyzed. Treatment for all patients was started between September 2012 and October 2o21.
Among the 33 patients treated, 20 were men and 13 were women, and all but three were white. While five patients had isolated cardiac sarcoidosis, the remaining 28 also had sarcoidosis in other areas of the body. The mean number of organs involved was 2.76.
Prednisone-only treatment was used in 30 cases, while 23 also added methotrexate, and eight involved infliximab. Of those eight, two patients also were using methotrexate.
About 60% of patients using either of these two additional medications had previously undergone an unsuccessful prednisone-tapering regimen, which was significantly more than the 20% in the prednisone-only group.
Successful treatment was defined as achieving a daily dose of prednisone up to 7.5 mg for at least six months. This outcome was evident in 26.7% of prednisone-only and 13% of prednisone-methotrexate cases, but was significantly more frequent when infliximab was used — working in 75% of cases.
The dose of prednisone needed with infliximab also was significantly lower. The lowest mean daily dose these patients could use without disease reactivation was 7.8 mg, compared with 14.1 mg for prednisone-only and 16.9 mg for prednisone-methotrexate.
In nine instances, prednisone could be completely tapered off. This included four cases in which infliximab was used, four with prednisone only, and one involving methotrexate. The remaining 52 cases involved an adverse cardiac event, which prompted termination of the tapering regimen.
Ultimately, “we found that infliximab-containing regimens were superior to regimens containing prednisone alone or prednisone plus methotrexate,” the researchers wrote.
Notably, in contrast to previous recommendations, “the prednisone plus methotrexate regimens were not more successful than in the prednisone-only tapering regimens.”
“This finding may be explained by the fact that the prednisone plus methotrexate regimens were given a greater percentage of time to patients who had previously failed a prednisone-only regimen,” and could reflect a more treatment-resistant disease, the team noted.
The superiority of infliximab was seen even though it also was likely to have been administered after a previous prednisone-tapering regimen had failed, the scientists added.
About the Author
