Mallinckrodt announced data from a retrospective chart review that analyzed physician assessments of 91 U.S. patients diagnosed with uveitis who had been treated with Acthar Gel (repository corticotropin injection) in the previous 12 months. All patients had completed or were still receiving treatment at the time of the review. In response to a survey question, physicians reported that 84 percent of patients who completed or were still in treatment with Acthar Gel had improvement in disease status overall, and 86 percent had improvements in vision.
Results of the study were recently published online ahead of print in the Journal of Ocular Pharmacology and Therapeutics.
Acthar Gel is FDA-approved for the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis and anterior segment inflammation.
“This is one of the first and largest studies of its kind to look at real-world medication patterns in the treatment of uveitis – for which data are greatly limited – and demonstrates our commitment to support informed and appropriate decision-making for patients,” Tunde Otulana, MD, Senior Vice President and Chief Medical Officer at Mallinckrodt, said in a company news release. “We are committed to examining treatments and clinical practices for patients with uveitis that can lead to improvements in their disease management. Real-world data can provide additional evidence of the potential utility of available therapeutic options for patients.”
- The study was a retrospective medical record review of physicians’ assessments of 91 patients diagnosed with uveitis, most of whom had moderate to severe visual impairment, who were treated with Acthar Gel. Average time since diagnosis was 4 years.
- Patients were selected from among a nationally representative sample of 21 ophthalmologists who were randomly selected for recruitment from a database of Acthar Gel prescribers and from the American Medical Association Physician Masterfile (a national database of physicians). Data were abstracted from patient medical records using an electronic data collection instrument and were collected between September and October 2017.
- Signs and symptoms noted at baseline included blurred vision, light sensitivity, floaters, loss of visual acuity, eye pain, and eye redness. Disease severity was most often moderate.
- All patients were taking other medications for uveitis before initiation of Acthar Gel. These included steroid eye drops, oral steroids, intraocular steroid injections, nonsteroidal eye drops and biologics.
- All patients had received treatment with Acthar Gel in the past 12 months and had either completed a course of Acthar Gel or were receiving Acthar Gel treatment at the time of data collection.
- There were 17 different initial dosing regimens documented in the study; however, most patients (n=70, 77 percent) were prescribed an initial regimen of 40–80 units, administered subcutaneously once or twice weekly. According to the Acthar Gel prescribing information, usual dosing of Acthar Gel is 40–80 units via subcutaneous or intramuscular injection every 1-3 days.
Highlights of the Assessments
- Based on notes in medical records, physicians reported that overall disease status had improved in 84 percent (n=76) of patients after therapy with Acthar Gel. They also reported:
- 86 percent (n=78) had improvements in vision.
- 27 percent (n=25) had improvements in eye pain.
- 26 percent (n=24) had improvements in vitreous haze.
- 24 percent (n=22) had reduction of background medication use.
- 23 percent (n=21) had improvements in vitreous flare.
- 18 percent (n=16) had improvements in macular edema.
- Of the patients treated with Acthar Gel, the number who were taking concomitant uveitis medications was reduced over time.
- At the start of treatment with Acthar Gel, 100 percent (n=91) of patients were on concomitant uveitis medication.
- During treatment with Acthar Gel, the number of patients on concomitant uveitis treatment decreased to 57 percent (n=52).
- Three months after initiation of Acthar Gel therapy, 22 percent (n=20) of patients remained on concomitant uveitis therapy. Among these patients, many were able to reduce their dose of concomitant uveitis medications.
- The study was a retrospective collection of data from medical records, which may be incomplete.
- Outcomes may be influenced by therapies not documented in the patient medical records.
- The study’s scope did not include quantification of patients’ outcomes, such as diagnostic measurements or safety endpoints.
- Physician assessments of patient outcomes may be subjective.
- Most patients were on multiple therapies so clinical outcomes may not be solely attributable to Acthar Gel.
The study was conducted by Mallinckrodt.
“These data add to the body of knowledge on uveitis, a leading cause of preventable blindness in adults in the U.S., and enhance understanding of treatment options for uveitis,” Robert C. Wang, MD, Partner, Texas Retina Associates, Dallas Texas, Clinical Associate Professor, UTSW Dallas Texas, said in the news release. “Studies designed to assess medication utilization and practice patterns are greatly needed to guide appropriate treatment decisions for uveitis patients.”