This article is more than 5 years old. Information may no longer be current.
Acthar Gel Offers Potential Alternative for Unresponsive, Persistent RA
CHICAGO — Repository corticotropin injection demonstrated potential as a safe and effective treatment option among patients with persistently active rheumatoid arthritis who were unresponsive to treatment with corticosteroids and conventional synthetic or biologic disease-modifying antirheumatic drugs, according to findings presented here.
“There has been discussion amongst rheumatologists as to the appropriate use of repository corticotropin in the treatment of rheumatoid arthritis,” Roy Fleischmann, MD, co-medical director of the Metroplex Clinical Research Center in Dallas, told Healio Rheumatology. “[However,] the usefulness of repository corticotropin injections in the treatment of RA could only be assessed in a powered, prospective, randomized, placebo-controlled trial in a population at risk in which the efficacy and safety could be reliably estimated.”
He noted “For this reason, a trial was designed to treat patients with refractory RA who still had active disease despite treatment with corticosteroids and having been exposed to multiple DMARDs.”
To evaluate the efficacy, safety and appropriate duration of repository corticotropin (H.P. Acthar Gel, Mallinckrodt Pharmaceuticals) injections in patients with persistently active RA despite receipt of conventional synthetic or biologic DMARDs and corticosteroids, Fleischmann and colleagues enrolled patients enrolled patients to receive 1 mL repository corticotropin subcutaneously twice weekly for 12 weeks.
Following the initial 12 weeks, the researchers enrolled patient who achieved low disease activity (DAS28-ESR score < 3.2) in a doubleblind maintenance phase of the trial, in which patients were randomized 1:1 to receive either 1 mL repository corticotropin subcutaneously twice weekly or matching placebo for an additional 12 weeks.
Fleischmann and colleagues noted that as of May 10, 2018, 116 patients had been enrolled, 100 had completed, two were ongoing and 14 had discontinued the 12-week open-label period of the study. The researchers observed that among patients who completed the open-label period, the mean patient age was 54 years and 84% of the patients were women.
According to interim study findings, 12 weeks of repository corticotropin resulted in more than 60% of patients achieving low disease activity.
“What we have seen in these first 50% of patients is that the majority of patients achieve low disease activity between 8 and 12 weeks,” Fleischmann said. “The question remains about what happens after 12 weeks when patients are randomized to placebo or continue on corticotropin in a blinded study? Is the effect going to last or are we going to have to continue to give the corticotropin? And what about safety?”
Common adverse effects included headache (n = 10), urinary tract infection (n = 4), hyperglycemia (n = 3), and pharyngitis (n = 3); additionally, two patients reported serious adverse events with chest pain and pneumonia.
“These are very preliminary results, but at least we can say that — in an open-label study — [corticotropin] was effective in a majority of patients after 8 weeks,” Fleischmann said.
Disclosure: Fleischmann reports relationships with AbbVie, Amgen, Lilly, Gilead, Mallinckrodt Pharmaceuticals and Pfizer. Please see the study for all other authors’ relevant financial disclosures.
Reference:
Fleischmann R, et al. Abstract 2528. Presented at ACR/ARHP Annual Meeting, Oct. 20-24, 2018; Chicago.
Perspective
Back to Top
In a phase 4 study interim analysis assessing the efficacy and safety of repository corticotropin injection in adult subjects with RA with persistently active disease despite treatment with corticosteroids and DMARDs, 61% of the 100 patients who had completed the open-label period achieved Low Disease Activity (LDA) at 12 weeks at the midway point of study enrollment.
These interim findings shed light on the potential safety and effectiveness of repository corticotropin injection as a treatment option for patients with persistently active RA who had an inadequate response to corticosteroids and DMARDs.
Rheumatologists are tenacious in their treatment of rheumatoid arthritis. Our ultimate goal is a cure; however, until a cure is found, we will treat our patients to LDA. With more than 60 years on the market, repository corticotropin injection has been shown to be an effective therapeutic option to help our patients achieve the goal of LDA.
It is essential that we, as practicing rheumatologists, use all of the tools in our toolbox. As subspecialists, we have the privilege of treating the difficult patients: those who do not respond to conventional synthetic and/or biologic DMARD treatment. We have good preliminary evidence that repository corticotropin injection is a reliable therapeutic option for these patients.
At the end of the day, all rheumatologists want to be able to say, “I have given my patient the best care I know.” That means leaving it all on the field, leaving no stone unturned and using all the tools available. Repository corticotropin injection has a long history, and was and continues to be an effective treatment for RA.