Physicians will soon have a new guideline for the management of psoriatic arthritis (PsA). This ambitious undertaking, the details of which were presented recently at the American College of Rheumatology (ACR) Annual Meeting, involved a large panel of experts who analyzed and synthesized the best available evidence to create and support the recommendations.
The proposed guideline – which contains approximately 80 recommendations – will undergo final review prior to consideration for publication in 2018 in the journals Arthritis Care & Research and Arthritis & Rheumatism. It will help rheumatologists select treatments for their psoriatic arthritis patients based on the best available evidence, especially in light of all the new treatments recently approved for PsA by the Food and Drug Administration (FDA).
A Need for a PsA Guideline?
“[The ACR hasn’t] had formal guidelines for PsA before, but now we have a lot of new treatment options for the management of this disease,” says Jasvinder Singh, MD, head of the panel that created the guideline and professor at the University of Alabama in Birmingham. “There is a real need for a guideline to prioritize these options for doctors and patients,” he says. The guideline was developed jointly by representatives from ACR and the National Psoriasis Foundation (NPF).
“[The guideline was] developed by a rigorous process of gathering and evaluating evidence, synthesizing it and coming up with a consensus. The guideline addresses both drug and non-drug interventions,” Dr. Singh explains.
It covers all potential treatment options, including FDA-approved drugs as well as drugs that have the potential to be approved. “There are drugs on the market for rheumatoid arthritis that clinicians and patients may already be using for PsA,” he says. “We felt compelled to include all valid treatment options. We want to be sure this guideline is up to date by the time that it is published.”
At the ACR’s Annual Meeting, Dr. Singh presented highlights of the draft guideline and the levels of evidence to support them. Broadly speaking, the guideline covers common scenarios for treating people with active PsA who have never been treated as well as those who have been treated but still have active disease. It also provides recommendations for people who have active PsA with inflammation of the tendons and ligaments around the joints (enthesitis), as well as those with inflammation of joints and other adjacent structures in the spine and those with active PsA plus co-existing inflammatory bowel disease. The guideline emphasizes the need to treat with the goal of achieving minimal disease activity.
Side effects, costs of therapies and patient preferences were factored into the recommendations. In fact, a group of PsA patients helped to develop the guideline and voted on the recommendations. This approach is the ACR’s standard for guideline development for rheumatologic diseases. It ensures that the recommendations are patient-centered and that patients have a voice in the process.
What Can Patients Expect?
Almost 94 percent of the recommendations are “conditional,” meaning that the best available evidence did not allow for a “strong” recommendation. This is in part because most published studies do not compare one treatment to another, but only to placebo, so it is difficult to say how one treatment directly stacks up against another.
As a major principle, the panel recommended aggressive treatment of active PsA using a treat-to-target approach – that is, adjusting a patient’s therapy as necessary to achieve a specific goal (usually remission or low disease activity) – rather than not treating to target. “Untreated disease or suboptimal disease control is not desirable, and in the current era, with availability of a lot of options, good disease control is achievable,” says Dr. Singh.
He says that, for most people with active PsA who have never been treated, TNF inhibitors, a type of biologic, are preferred over traditional disease-modifying drugs such as methotrexate, leflunomide (Arava), sulfasalazine (Azulfidine) and apremilast (Otezla), which are called oral small molecules (OSMs) in this guideline.
This conditional recommendation is based on moderate- to low-quality evidence, he says. “Choices of therapy should always be discussed with the patient. There may be circumstances where [traditional oral] drugs may be preferred,” such as a patient’s preference for an oral rather than an injectable drug; or contraindications to a TNF inhibitor biologic, including serious infections, heart failure and demyelinating disease (for example, multiple sclerosis).
The guideline also specifies when patients should get common vaccinations. If a patient with active PsA requires a killed vaccine (such as the flu or pneumonia vaccine), starting treatment with a biologic therapy should not be delayed; however, if a patient needs a live attenuated vaccine, biologic therapy should be delayed until after the patient is vaccinated.
Regarding non-drug interventions, the panel made a “strong” recommendation for smoking cessation (all the available evidence shows that not smoking is beneficial). Other non-drug interventions – including exercise, low-impact exercise, physical therapy, occupational therapy, weight loss if overweight or obese, massage therapy or acupuncture – were “conditional,” with low to very low quality of evidence to support them.
Commenting on the importance of the new guideline, Liron Caplan, MD, associate professor medicine-rheumatology at the University of Colorado School of Medicine in Denver, points out some major differences in this guideline compared to guidelines for treating rheumatoid arthritis. “For example, in treatment-naïve patients with active PsA, the experts recommended a TNF [inhibitor] biologic over conventional disease modifying anti-rheumatic drugs (DMARDs) as a first-line option. Other guidelines have been more willing to promote an initial trial of conventional DMARDs,” Dr. Caplan explains.
Another big difference: “The guideline incorporated patients’ opinions to a degree not typically seen” in those developed in other areas of medicine, he says. “But because of the limited hard scientific evidence, treatment decisions still allow for a fair amount of flexibility that patients can explore through an informed discussion with their health care provider.”
Dr. Caplan concludes, “It is probably safe to assume that this is the most rigorously produced PsA guideline to date.” However, better scientific studies are needed so that the recommendations can be “strong” and not “conditional,” he points out. “The current recommendations continue to rely fairly heavily on expert opinion,” he says.