Biologics effective against nonresponding Sjögren’s syndrome

Casey L. Hogan

SAN ANTONIO – More than 200 biologic agents are available, and their use is becoming more common in eye care, Casey L. Hogan, OD, FAAO, FSLS, said here at the Anterior Segment Section Symposium during the American Academy of Optometry meeting.

Primary Care Optometry News sponsored the symposium.

Humira (adalimumab, ABBvie) is being used to treat noninfectious uveitis, Rituxan (rituximab, Roche/Genentech) is commonly being used to treat Sjögren’s syndrome, and Avastin (bevacizumab, Roche) is being used for age-related macular degeneration.

Hogan said the FDA defines a biologic as a product that can be a, “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product or analogous product applicable to the prevention, treatment or cure of a disease or condition of human beings.”

She said that biologics differ from conventional drugs in a number of ways: They are much more complex, identical copies are not reproducible, they are highly sensitive to external conditions and environmental changes, they have a higher immunogenic potential and they are made up of macromolecules.

Biosimilars, Hogan noted, are defined by the FDA as biologic products that are approved based on demonstrating the biosimilar is, “highly similar to an FDA-approved biologic product known as a ‘reference product’ notwithstanding minor differences in clinically inactive components.” There are no “clinically meaningful differences between the biologic product and the reference product in terms of safety, purity and potency.”

While Sjögren’s syndrome is commonly treated with rituximab, it is considered off label, Hogan said.

“It may be considered for therapeutic option in adults with primary Sjögren’s syndrome and any or all of the associated systemic manifestations: pulmonary disease, inflammatory arthritis, cryoglobulinemia associated with vasculitis, peripheral neuropathy and severe parotid swelling,” she said.

“How about Sjögren’s syndrome patients with dry eye?” Hogan proposed.

According to a statement from the Sjögren’s Syndrome Foundation Consensus Panel: “Rituximab may be considered an option for keratoconjunctivitis in patients with primary Sjögren’s syndrome when conventional therapies have proven insufficient. TNF-alpha inhibitors should not be used for treatment of sicca symptoms in patients with primary Sjögren’s syndrome.”

Symposium moderator Walter Whitley, OD, MBA, FAAO, asked Hogan if the literature supports the use of Rituxan for treating dry eye.

“About seven studies look at it,” she said. “Unfortunately, only one of the seven studies showed efficacy.”

Hogan said there are two major studies, Tolerance and efficacy of rituximab in primary Sjögren’s syndrome (TEARS) and the TRACTISS trial.

“All used the Schirmer’s test, and its use in Sjögren’s syndrome patients isn’t reliable,” she said.

TEARS showed improvement in lacrimal function, Hogan said.

“The TRACTISS trial used staining, and it did show efficacy,” she added. – by Nancy Hemphill, ELS, FAAO

References:

Brown S, et al. BMC Musculoskelet Disord. 2014;doi:10.1186/1471-2474-15-21.

Devauchelle-Pensec V, et al. Ann Intern Med. 2014;doi:10.7326/M13-1085.

Whitley W, et al. Biologic therapy: Applications in anterior segment disease. Presented at: American Academy of Optometry meeting; San Antonio; November 7-10, 2018.

Disclosures: Hogan reported no relevant financial disclosures. Whitley has received honorarium, consulting fees or research funding from: Alcon, Allergan, Bausch + Lomb, Beaver Visitec, Biotissue, Carl Zeiss Meditec, Johnson & Johnson Vision Care, Ocusoft, Shire, Sun Pharmaceuticals, Eyegate and TearLab.