Little Evidence to Support Use of Pricey Repository Corticotropin

NEW YORK (Reuters Health) – Repository corticotropin costs much more than corticosteroids, but shows little clinical benefit over them, results of a scoping review suggest.

“In this comprehensive review, we found that the clinical evidence supporting the use of repository corticotropin for most of its indications was very weak, consisting primarily of uncontrolled or small placebo-controlled studies,” Dr. Daniel M. Hartung of Oregon Health & Science University in Portland told Reuters Health by email.

“The evidence was most reliable for two indications: treating relapses of multiple sclerosis and infantile spasms. However, for both of those conditions, most trials indicated that repository corticotropin was not superior to corticosteroids,” he added. “The lack of compelling data to support the use of repository corticotropin over lower-cost corticosteroids calls into question the continued coverage of this medication by public payers such as Medicare.”

As reported in JAMA Internal Medicine, Dr. Hartung and his colleagues searched standard medical databases from inception through mid-2021 to examine clinical evidence that supported using repository corticotropin injection for its approved conditions. They reviewed randomized controlled trials (RCTs), nonrandomized and single-arm clinical trials, as well as prospective studies that compared repository corticotropin with a placebo, an active comparator, or no treatment.

The research team found 41 studies involving 2,235 participants that met their inclusion criteria: 11 on infantile spasms, 11 on rheumatological conditions, 10 on multiple sclerosis (MS), seven on nephrotic syndrome, one on sarcoidosis, and one on ocular conditions. Of these, 19 studies either included a single arm or only compared different repository corticotropin dosing strategies.

The evidence was strongest in studies involving MS and infantile spasms. The four studies that compared repository corticotropin with an active agent, and the five studies that compared the drug to placebo, involved MS. Almost all those studies found that repository corticotropin performed better than placebo but not corticosteroids.

Of the eight controlled (six randomized) studies that involved treatment of infantile spasms, only one small RCT found repository corticotropin to be significantly better than corticosteroids.

Among the 20 studies of other conditions, 12 lacked a control group, five were placebo-controlled, and two only examined different corticotropin dosing strategies.

Placebo-controlled RCTs of ankylosing spondylitis, nephrotic syndrome, optic neuritis, rheumatoid arthritis and systemic lupus erythematosus tended to be small and did not always show repository corticotropin’s superiority to placebo. In blinded RCTs, repository corticotropin was linked with a similar or greater number of adverse events than corticosteroids.

“Repository corticotropin is a very expensive medication that was approved nearly 70 years ago, when the United States Food and Drug Administration’s approval standards were not as rigorous,” Dr. Hartung explained. “As a consequence, the value of repository corticotropin for many of its approved indications has been questioned.”

SOURCE: JAMA Internal Medicine, online December 13, 2021.

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