The smaller, incomplete study is looking into both the efficacy and safety of the longtime therapy for patients with RA.
In an ongoing multicenter study assessing repository corticotropin injection’s efficacy and safety in patients with rheumatoid arthritis, investigators have found early positive results for benefit. The study, which was presented at the American College of Rheumatology (ACR) annual meeting in Chicago, IL, is a small one, W. Hayes Wilson, MD, observed. But it’s still critical.
In an interview with MD Magazine®, Wilson, a rheumatologist at Piedmont Hospital, Atlanta, GA, discussed the consistent safety concerns and questionable long-term use of repository corticotropin injection for rheumatoid arthritis.
MD Mag: What were the results of the efficacy/safety study of repository corticotropin injection in patients with rheumatoid arthritis?
Wilson: This is a small study and it’s not complete, yet. [Investigators enrolled] about 116 people. [At the time of the presentation] about 100 people [had completed the study]. It is a 12-week trial. [The investigators] were looking to see if there was efficacy and safety using repository corticotropin injection in patients with rheumatoid arthritis who had failed 1 or 2 disease-modifying antirheumatic drugs (DMARDs); either conventional or synthetic DMARDS, and/or biological DMARDS.
Should repository corticotropin injection be used instead of DMARDs on in combination with it?
When I use it, I use it mostly in conjunction with DMARDS. In most of rheumatology, you try to start out with the simple medications and then work your way up and then, often times, you’re limited if the next medication that you try doesn’t work you have to move up another step. [Repository corticotropin injection] would be several steps up in the treatment paradigm, but it’s good to have it as available.
For instance, I might have 1200 patients that I’m seeing at any one time, and it may only be a dozen of them that may be benefitting from this medication. But, those are people that have been a challenge to treat, and so it’s good to have that tool available.
Is this a beneficial tool for long-term patient care?
It would be difficult for me to say if [repository corticotropin injection] would be used for a lifetime because it depends on how the patient is and how long their life is going to be. But, for long-term, I have certainly used it in people for more than 12 weeks—for 3 months, 6 months, and perhaps even a year—but as with all medications, when a patient gets into low disease activity, I try to see if I can simplify their treatment regimen. If someone does get into low disease activity, then I would try to taper [their treatment regimen] and see if they get in that low disease activity.
Did any adverse events or safety issues present in the study’s patients?
In this study, there were adverse events in 10 people who had headaches. There were several people who had a urinary tract infection and pharyngitis, and elevation of their blood sugar, which are common side effects that can occur in patients who are on medications that stimulate the adrenals to make steroids. Generally, eugenic effects [seen with steroids] would be the type of side effects that you may see with [repository corticotropin injection].
Are there any concerns of infection in patients?
There is always a concern about infection. Patients with rheumatoid arthritis are more at risk for infection anyway and then what you are trying to do [is] lower their immune response, because it’s their immune system that’s attacking them. When you lower that immune response, you increase their chances for infection. In fact, there were 2 serious adverse events in this study, one was chest pain and one was pneumonia.
The study, "A Multicenter Study Assessing the Efficacy and Safety of Repository Corticotropin Injection in Patients with Rheumatoid Arthritis: Preliminary Interim Data from the Open-Label Treatment Period," was presented at ACR 2018.