Effects of Subcutaneous Repository Corticotropin Gel Injection on Regulatory T Cell Population in Noninfectious Retinal Vasculitis

ABSTRACT

Aim

To evaluate the effect of repository corticotropin injection (RCI) on regulatory T cell population in patients with noninfectious retinal vasculitis.

Patients and Methods

Patients with active noninfectious retinal vasculitis were included in a prospective nonrandomized open-label study.

Results

Eighteen patients (33 eyes) were included in the study. Eleven (61.1%) patients [20 (60.6%) eyes] and 7 (38.9%) patients [13 (33.3%) eyes] were in the responsive and non-responsive groups, respectively. We did not find any statistically significant difference within the PPP-R group, within the PPP-NR group, or between these two groups in regard to regulatory T cell population. No significant systemic or ocular complications were found.

Conclusion

RCI may be a complementary treatment in patients with non-infectious retinal vasculitis with or without uveitis. This study did not demonstrate an increase in regulatory T cell population in patients with noninfectious retinal vasculitis.

KEYWORDS:

• Acthar
• CD4+
• CD25+
• FoxP3+
• regulatory T cell
• repository corticotropin injection (RCI)
• retinal vasculitis
• Treg
• uveitis

Highlights

Repository corticotropin injection (RCI) may be a complementary treatment for patients with non-infectious retinal vasculitis with or without uveitis. This study did not demonstrate a significant change in T regulatory cells population with RCI treatment.

Acknowledgments

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Data availability

The data that support the findings of this study are available from the corresponding author, upon reasonable request

Disclosure statement

Dr. C Stephen Foster declares the following: Consultancies with Aldeyra Therapeutics (Lexington, MA), Allakos (Redwood City, CA), Bausch & Lomb Surgical, Inc (Rancho Cucamonga, CA), Eyegate Pharma (Waltham, MA), Genentech (South San Francisco, CA), Novartis (Cambridge, MA), pSivida (Watertown, MA) Grants or grants pending with Aciont (Salt Lake City, UT), Alcon (Aliso Viejo, CA), Aldeyra Therapeutics (Lexington, MA), Bausch & Lomb (Rochester, NY), Clearside Biomedical (Alpharetta, GA), Dompé pharmaceutical (Milan, Italy), Eyegate Pharma (Waltham, MA), Mallinckrodt pharmaceuticals (Staines-upon-Thames, UK), Novartis Pharmaceuticals (Cambridge, MA), pSivida (Watertown, MA), Santen (Osaka, Japan) Payment for lectures including service on speaking bureaus: Alcon (Aliso Viejo, CA), Allergan (Dublin, Ireland), Mallinckrodt pharmaceuticals (Staines-upon-Thames, UK) Stock or Stock Options: Eyegate Pharma (Waltham, MA). Dr. Stephen D. Anesi declares the following: Consultancies with Santen (Osaka, Japan), Mallinckrodt (Staines-upon-Thames, UK), Allakos (Redwood City, CA), Eyepoint (Watertown, MA), and Takeda (Tokyo, Japan). Speakerships with AbbVie (Chicago, IL), Mallinckrodt (Staines-upon-Thames, UK), and Eyepoint (Watertown, MA). Dr. Peter Chang declares the following: Consultancies with Eyepoint (Watertown, MA) and Alimera (Alpharetta, GA). Speakerships with AbbVie (Chicago, IL), Mallinckrodt (Staines-upon-Thames, UK), and Eyepoint (Watertown, MA). All other authors have no proprietary or commercial interest in any materials discussed in this article or additional financial disclosures to declare.

Compliance with ethics guidelines

This study was approved by the New England Institutional Review Board and all participants provided written informed consent to participate in this prospective study.

This study was performed in accordance with the Helsinki Declaration of 1964, and its later amendments.

Additional information

Funding

This trial was supported by an investigator-initiated research grant from Mallinckrodt Pharmaceuticals, Bedminster, NJ. Mallinckrodt had no role in the design or conduct of this research nor production of this manuscript.