A new guideline from the British Society of Rheumatology (BSR) includes detailed advice for anti–tumor necrosis factor (TNF) treatment in adult psoriatic arthritis (PsA), including those with complicating conditions such as hepatitis, cancer, or pregnancy or who do not respond to an initial anti-TNF agent. The guideline, which was published online July 23 and in the October 10 print issue of Rheumatology, was developed on behalf of the BSR Clinical Affairs Committee & Standards, Audit and Guidelines Working Group and the British Health Professionals in Rheumatology.
"The new guideline reinforces previous guidelines and links in to the rheumatoid arthritis (RA) guidelines in terms of safety data. The key new information is advice for biologic treatment in 'difficult' cases such as those with hepatitis or [HIV] infection," lead author Laura C. Coates, MBChB, PhD, from the Academic Section of Musculoskeletal Disease, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals National Health Service Trust, United Kingdom, told Medscape Medical News.
According to the authors, the guideline objectives were to "provide a stepwise management plan giving clear advice on treatment from the initial diagnosis, including inclusion/exclusion criteria for treatment, monitoring requirements and how to quantify response to biologics. " The guidelines do not cover either juvenile idiopathic arthritis or psoriatic disease confined to the skin.
The key recommendations include new guidance on treating patients with psoriasis who have peripheral arthritis or axial disease. Recommended response measures are the PsA response criteria and the psoriasis area severity index score.
Safety guidance includes not beginning or continuing anti-TNF in the presence of serious active infection, educating patients on food safety, and maintaining a high index of suspicion for atypical or opportunistic infections.
The guideline also reiterates the recommendation to screen all patients for mycobacterial infection, HIV, hepatitis B virus, and hepatitis C virus before starting anti-TNF therapy, and HBV vaccination before treatment should be considered. "Physicians should be vigilant for the development of mycobacterial infections throughout treatment with anti-TNF and for at least 6 months after discontinuation," the authors warn.
According to the guideline, "HIV or HCV infection should not preclude treatment with anti-TNF therapy, although treatment should only be commenced in those with well-controlled disease and with appropriate monitoring under the care of a hepatologist or HIV specialist."
In cases in which the first anti-TNF treatment fails, either because of inefficacy or adverse events, the guideline recommends considering an alternative anti-TNF therapy.
Dr. Coates said the new guideline mainly codifies what is already being done, especially in peripheral PsA. However, she notes, the guidelines also highlight new evidence in other forms of PsA, particularly in oligoarthritis and enthesitis, which are not currently indications for the use of biologics, according to UK National Institute for Health and Care Excellence criteria.
"I think this guideline will be helpful," Susan M. Goodman, MD, associate attending rheumatologist at the Hospital for Special Surgery and associate professor of medicine at Weill Cornell Medical College in New York City, told Medscape Medical News. "This is a concise, clear summary that will be easy for clinicians to consider and will help decision making in areas which have become controversial. The results from studies of therapy for PsA have not been as clear as in RA, in part because the diagnosis of PsA is not made as quickly as is the diagnosis of RA, and in part as appropriate endpoints have been less well-defined for treatment than they have been for RA. PsA may take several clinical forms and can be hard to distinguish from other forms of arthritis, including erosive osteoarthritis. This also adds to the difficulty of study design to assess treatment responses when cases vary greatly. In addition, since PsA may be oligoarticular, response criteria defined as a 20%, 50%, or 70% change in active joints are difficult to apply, so clear study results have been elusive. Clear guidelines which consider these differences will be useful for clinicians,"
Dr. Goodman, who was not involved in the project, said that although the guidelines in part codify what is already being done in clinical practice, they also provide a structure that may assist physicians in obtaining insurance approval for the use of biologics in PsA.
Dr. Coates has received honoraria and/or funding for clinical trials from Abbott, Merck Sharp & Dohme, Pfizer, and UCB. Other authors have received honoraria and/or grant support from Pfizer, UCB, Merck Sharp & Dohme, Abbott, Chugai-Roche, Janssen, Celgene, Roche, AstraZeneca, Servier, Amgen, and Abbvie. Dr. Goodman has disclosed no relevant financial relationships.
Rheumatology. 2013;52:1754-1757. Full text
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Cite this: Psoriatic Arthritis: Guidelines for Treatment With Biologics - Medscape - Nov 04, 2013.