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Navigating the Use of RCI in the Management Of NIU: A Delphi Study

Presenter:

Quan Dong Nguyen, MD, MSc.

Authors:

Quan Dong Nguyen, MD, MSc, FAAO, Stephen D. Anesi, MD, FACS, Saradha Chexal, MD, David S. Chu, MD, Pouya N. Dayani, MD, Theodore Leng, MD, FACS, Dhanu Meleth, MD, Ahmed Sallam, MD, PhD, FRCOphth, John D. Sheppard, Jr., MD, Steven M. Silverstein, MD, FACS, Joseph Tauber, MD, Rolando Toyos, MD, Robert C. Wang, MD, C. Stephen Foster, MD, FACS, FACR

  1. Byers Eye Institute, Stanford University School of Medicine, Palo Alto, California

  2. Massachusetts Eye Research & Surgery Institution (MERSI), Waltham, Massachusetts

  3. Retina Consultants of Austin, PA, Austin, Texas

  4. Institute of Ophthalmology and Visual Science, Rutgers New Jersey Medical School, Newark, New Jersey

  5. Metropolitan Eye Research and Surgery Institute, Palisades Park, New Jersey

  6. Retina‐Vitreous Associates Medical Group, Los Angeles, California

  7. Marietta Eye Clinic, Marietta, Georgia

  8. Jones Eye Institute, University of Arkansas for Medical Sciences, Little Rock, Arkansas

  9. Virginia Eye Consultants, Norfolk, Virginia

  10. University of Missouri Kansas City School of Medicine, Kansas City, Missouri

  11. Tauber Eye Center, Kansas City, Missouri

  12. Toyos Clinic, Germantown, Tennessee

  13. Texas Retina Associates, Dallas, Texas

Affiliation:

Purpose: Noninfectious uveitis (NIU) is a rare inflammatory condition associated with a high risk of significant visual loss. Corticosteroids are a mainstay of acute NIU management but are not appropriate for long‐ term therapy because of their well‐known side effects. As a result, a variety of systemic immunomodulatory therapies are also used in managing refractory NIU, many of which are not FDA approved for the treatment of NIU. Repository corticotropin injection (RCI) has received FDA approval for treatment of severe acute and chronic allergic and inflammatory processes involving the eye and is an option for treating NIU.

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Only limited clinical data on the use of RCI in NIU are available. We formed a panel of uveitis specialists experienced with RCI in NIU and used a modified Delphi process to develop consensus recommendations on patient selection, dosing, and adverse event management for RCI in the treatment of NIU. Given the lack of clinical evidence, these recommendations may be useful to clinicians who manage NIU.

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Methods: The modified Delphi process uses a series of 3 questionnaires. Questionnaire 1 employed open‐ended questions based on published literature and the RCI product labeling. Answers were provided by nine panelists, and were converted into statements for Questionnaire 2, which 14 panelists rated using a Likert scale ranging from –5 (strongly disagree) to +5 (strongly agree). Questionnaire 3 repeated Questionnaire 2 with some refinement and expansion. For Questionnaire 3, panelists were provided with summary results from Questionnaire 2 to promote consensus. Consensus was defined as a mean rating ≥ +2.5 or ≤ –2.5 with a standard deviation that did not cross zero.

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Results: Questionnaire 3 was completed by 14 panelists, who rated 397 statements and reached consensus on 208. Panelists reached consensus that RCI is an option for intermediate NIU, posterior NIU, and panuveitis. Panelists also agreed that the RCI dosage should be individualized for each patient. In patients receiving RCI and concomitant steroids, systemic steroids should be tapered or weaned. The RCI dose should be reduced or discontinued if hyperglycemia and/or diabetic complications develop, response to RCI is lost, or remission occurs. Recommendations for adverse event management addressed dose adjustment and pharmacologic and non‐pharmacologic interventions.

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Conclusions: The modified Delphi process yielded consensus recommendations on the use of RCI in the treatment of NIU.

 

Funding: This work was supported by a medical writing grant from Mallinckrodt Pharmaceuticals.

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