Perspective from Barry L. Gruber, MD
Disclosures: Rosenbaum reports consulting fees from AbbVie, UCB, Gilead Sciences, Novartis, Horizon, Roche, Eyevensys, Santen, Corvus, Affibody and Kyverna, as well as grant support from Pfizer and Horizon. Please see the study for all other authors’ relevant financial disclosures.
February 24, 2021
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ACR, medical societies reach consensus on hydroxychloroquine retinopathy

Perspective from Barry L. Gruber, MD
Disclosures: Rosenbaum reports consulting fees from AbbVie, UCB, Gilead Sciences, Novartis, Horizon, Roche, Eyevensys, Santen, Corvus, Affibody and Kyverna, as well as grant support from Pfizer and Horizon. Please see the study for all other authors’ relevant financial disclosures.
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With proper dosing — 5 mg/kg or less per day — the risk for retinal toxicity associated with hydroxychloroquine use is less than 2% for up to 10 years, according to a joint statement from four medical societies.

Released by the American College of Rheumatology, American Academy of Ophthalmology, the American Academy of Dermatology and the Rheumatologic Dermatology Society, and published in Arthritis & Rheumatology, the statement also declares that widespread use of more sensitive tests, such as optical coherence tomography (OCT), can now detect early retinopathy and preserve eye function in patients receiving the drug.

Female eye up close
“Guidelines from ophthalmologists were published in 2016 but prescribers like rheumatologists and dermatologists have remained skeptical,” James T. Rosenbaum, MD, told Healio Rheumatology. “This statement signifies a coming together with agreement and with the hope for better communication.”. Source: Adobe Stock

“Prescribing clinicians and eye care specialists share responsibility for safely prescribing hydroxychloroquine (HCQ) and screening for the potential risk of retinopathy,” James T. Rosenbaum, MD, of the departments of medicine, ophthalmology and cell biology at Oregon Health & Science University, and colleagues wrote.

“Two relevant national societies, the ACR and the AAO, have independently offered management guidelines, but this is the first joint statement to emphasize points of agreement that should be recognized by practitioners in all specialties,” they added. “The ACR and AAO are joined in this statement with the AAD and RDS.”

To promote the need for collaborative management of hydroxychloroquine retinopathy, and combat the dearth of information on proper dosage, the four societies recruited a working group of seven rheumatologists, two ophthalmologists and two dermatologists. Members were brought into the group based on their expertise and publication record, with considerations made for gender, age and U.S. geographic diversity.

The working group consulted the literature to determine whether any new developments in their fields may require changes to the basic principles of management described in the AAO’s 2016 guidelines. In addition, the committee identified which parts of those 2016 recommendations that were applicable and acceptable to the physicians most likely to prescribe hydroxychloroquine.

James T. Rosenbaum

“Hydroxychloroquine is unusual in that the prescribing doctor is rarely the doctor who monitors the safety,” Rosenbaum told Healio Rheumatology. “Guidelines from ophthalmologists were published in 2016 but prescribers like rheumatologists and dermatologists have remained skeptical. This statement signifies a coming together with agreement and with the hope for better communication.”

According to the joint statement, effective communication between health care providers is a key factor in the management of hydroxychloroquine. It is the responsibility of the rheumatologist, dermatologist or other non-ophthalmic clinician to prescribe the drug properly, but the responsibility of the ophthalmologist or other eye care professional to screen correctly for toxicity, the authors wrote. In addition, it is the responsibility of all involved to advise patients regarding the risk for retinopathy, and to work together to ensure optimal care.

Regarding hydroxychloroquine dosing, data suggest that an average daily regimen of 5 mg/kg in actual weight, or less, provided a low risk for toxicity — less than 2% for up to a decade of use. Higher average daily amounts increase the risk for retinopathy to approximately 10% after 10 years, with the risk continuing to rise with longer duration of use. According to the statement, high daily doses of hydroxychloroquine relative to body weight, and cumulative doses, are the primary risk factors for eye toxicity. Patients with renal insufficiency may need lower doses and closer monitoring, they added.

However, for patients with a normal screening exam in a given year, the risk for retinopathy in the ensuing year is less than 5%, even after 20 years of use.

For screening, the statement recommends a baseline retinal exam within the first few months of hydroxychloroquine use, to rule out any underlying disease that might compromise eye function or make it harder to recognize retinopathy. Meanwhile, the “mainstays” of early retinopathy detection are OCT and automated visual fields.

“The key to effective management of HCQ to avoid retinopathy is proper dosing, awareness of additional risk factors, and effective screening with modern techniques, in particular OCT,” Rosenbaum and colleagues wrote. “For this to succeed, eye care providers need to communicate with patients and with clinicians who prescribe HCQ.”

“It is important that the drug is not stopped prematurely, but also that it is not continued in the face of definitive evidence of retinal toxicity except in some situations with unusual medical need,” they added. “It is essential that patients are aware of the risks, dosage, the importance of screening, and how HCQ contributes to control of their disease. Overall, the risk of retinopathy is very low if these principles are followed.”