The guideline notes that available, low-quality evidence is inconclusive regarding the efficacy of OSMs in the management of PsA. There is, however, moderate-quality evidence of the benefits of TNFi biologics, particularly for their impact on prevention of disease progression and joint damage.
One potential problem with this recommendation could be insurance coverage for use of a TNFi instead of methotrexate. Although the panel recognized that cost could be a factor, it “put considerations of quality of evidence for benefit over other considerations.”
The guideline was developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, which rates the quality of the available evidence. Four teams selected by the ACR Quality of Care Committee worked on development:
- The Core Leadership Team supervised and coordinated the project;
- The Literature Review Team completed the literature search and abstraction;
- The Expert Panel, which included patients, patient advocates, rheumatologists, dermatologists, a dermatologist-rheumatologist and a rheumatology nurse practitioner, developed clinical questions (e.g., population, intervention, comparator outcomes [PICO]); and
- The Voting Panel, which included practitioners and patients.
A Patient Panel also reviewed the evidence and offered insights about values and preferences.
“Having the patient voice in every recommendation was important to the development of the guideline,” Dr. Ogdie says. “[The] separate Patient Panel gave us their input about the different recommendations. Most important, however, was the qualitative feedback they provided about their experiences with the different therapies. Bringing those to the table was really helpful in making some decisions.”
Patients outlined the negative effects of fatigue, nausea and malaise on their quality of life, and the potential risk for these side effects with certain therapies. They noted that some therapies could mean increased copayments, require additional travel time for more frequent appointments and increase adverse events.
The systematic literature review for guideline development spanned published English-language literature from the beginning of each database through mid-November 2016. Updated searches were completed on May 2, 2017, and March 8, 2018.
The Voting Panel, which included two patients, achieved consensus on the direction and strength of the recommendations included in the guideline. Six percent of the recommendations were strong, meaning the panel was confident the desirable effects of following the recommendation would outweigh the undesirable effects. The course of action for this type of recommendation should, therefore, apply to all or almost all patients. Strong recommendations were based on moderate- or high-quality evidence.
Ninety-four percent of the recommendations were conditional and were usually based on low- to very low-quality evidence. The guideline describes a conditional recommendation as one for which the desirable effects of following the recommendation probably outweigh the undesirable effects. The course of action would apply to a majority of patients, but a small proportion of clinicians and patients may not want to follow the recommendation. Conditional recommendations “are preference sensitive and always warrant a shared decision-making approach,” according to the guideline.