The first clinical practice guidelines for Sjögren’s syndrome have been released, the culmination of an initiative by the Sjögren’s Syndrome Foundation.1 These standard-of-care recommendations are intended to provide consistency in practice patterns, inform coverage and reimbursement policies, lead to the design and implementation of educational programs, highlight the needs for future research and fill a significant clinical void, according to the document published in Arthritis Care & Research, April 2017.
The Sjögren’s Syndrome Foundation effort was led by CEO Steven Taylor and Vice President for Research Katherine Moreland Hammitt. The guidelines represent the first phase of treatment guidelines for Sjögren’s syndrome and address the use of biologic agents, management of fatigue and inflammatory musculoskeletal pain. The first phase was chaired by Fredrick B. Vivino, MD, at Penn Presbyterian Medical Center, University of Pennsylvania. The next set of guidelines, which will be developed over the next couple of years, will look at several more of the 10 issues considered most important by the guidelines committee.
Lead author Steven E. Carsons, MD, at NYU Winthrop Hospital Campus and professor of medicine at Stony Brook University School of Medicine, says the clinical practice guidelines “will be extremely valuable for clinicians who treat Sjögren’s and for payers as a guide to appropriate management strategies. These are the first formally constructed guidelines for Sjögren’s syndrome intended for U.S. practitioners, … and they provide some clarity toward a preferred approach to the management of the manifestations of Sjögren’s.”
The Sjögren’s Syndrome Foundation, founded about 35 years ago, was the first organization to raise awareness about the disorder, Dr. Carsons says. “On the basis of [its] efforts and efforts by others in Europe and elsewhere, there is now an awareness of Sjögren’s among patients and physicians.” This awareness has fostered a marked increase in research. “The culmination of all this interest and the environment of advances in so many other fields in rheumatology led to questions about what we can do about Sjögren’s, an area where we have not had a lot of good therapies and direction.”
In recent years, there has been a “fairly significant uptick in the number of agents being developed for Sjögren’s, and quite a few clinical trials in the U.S., Europe and other countries are now enrolling [patients]. That is in stark contrast to even five years ago,” Dr. Carsons says. Also, earlier this year, the ACR and EULAR released classification criteria for primary Sjögren’s syndrome, intended to improve the comparison of results across clinical studies and to aid in recruitment of patients for trials.2
Guidelines Development
The Clinical Practice Guidelines Committee employed a systematic review of the literature to inform a consensus expert panel (CEP), Dr. Carsons says. Recommendations were formulated by the experts according to the available literature and extrapolation from management of similar circumstances in other rheumatic diseases. The CEP, comprising rheumatologists, dentists, ophthalmologists, nurses, patients and allied health professionals, used Delphi methodology to achieve a 75% or greater consensus among the 30–40 participants for each of the recommendations.