SAN DIEGO — A tight treat-to-target strategy is more effective than standard care for reducing disease activity in the skin and joints of patients newly diagnosed with psoriatic arthritis, according to results from TICOPA, the first study to evaluate the strategy in this patient population.
"Treating to a specific objective target is more ambitious than just asking a patient how he or she feels," said lead investigator Laura Coates, MD, from the University of Leeds in the United Kingdom. "Tight control aims for excellent disease control and should ensure that the patient is feeling well. Setting this high bar helped improve outcomes for patients with psoriatic arthritis," she reported.
Dr. Coates presented the results here at the American College of Rheumatology (ACR) 2013 Annual Meeting.
In the multicenter, open-label, randomized controlled trial, the 206 participants were newly diagnosed with psoriatic arthritis and were naïve to treatment with conventional and biologic disease-modifying antirheumatic drugs (DMARDs).
Investigators assigned half the patients to tight control using a treat-to-target strategy that was validated in patients with rheumatoid arthritis; they assigned the other half to standard care.
In the tight control group, investigators escalated therapy if the target of minimal disease activity was not met. Patients were started on methotrexate, and the dose was rapidly escalated to 25 mg after 6 weeks.
After 12 weeks, if minimal disease activity was not achieved, patients received combination DMARD therapy. After another 12 weeks, they received anti-TNF therapy if they had 3 or more tender and swollen joints, or received an alternative DMARD in combination with methotrexate if they had not achieved minimal disease activity and had fewer than 3 swollen and tender joints.
Patients receiving standard care were seen every 3 months by a rheumatologist, but there was no set treatment protocol.
By week 48, more patients in the tight control group than in the standard care group had achieved a reduction in the signs and symptoms of psoriatic arthritis.
Table. Outcome at Week 48
|ACR Score||Tight Control Group, %||Standard Care Group, %||P Value|
Control of the skin manifestations of psoriasis, measured with the psoriatic arthritis skin index 75, was also better in the tight control group than in the standard care group (58.7% vs 33.3%).
Adverse events were reported by 97% of patients in the tight control group and by 80% of those in the standard care group. The most common adverse events were nausea, liver function abnormalities, and respiratory tract infections.
"The frequency of side effects was increased in the tight control arm of the study, but the majority of patients tolerated treatment well," Dr. Coates said.
"This study was modeled after the TICORA study in rheumatoid arthritis, which showed that tight control improved outcomes," said session comoderator Arthur Kavanaugh, MD, from the University of California, San Diego.
"In this trial of psoriatic arthritis, tight control did better. Some of this may be explained by changes in medications. At the end of the day, more patients in the tight control arm received biologics. Taking this to the clinic, the study suggests that in psoriatic arthritis, it would be best to evaluate patients regularly and find the treatment that gets the patient to low disease activity," said Dr. Kavanaugh.
However, TICORA did not include biologics in the tight control group, noted comoderator John Cush, MD, director of clinical rheumatology for the Baylor Research Institute in Dallas.
Therefore, "in TICOPA, you can't be sure if it is tight control or the use of biologics that accounted for the results."
Dr. Kavanaugh said he agrees. "We look forward to longer-term data from this trial and an analysis of which patients are the best candidates for the tight control approach."
Dr. Coates and Dr. Kavanaugh have disclosed no relevant financial relationships. Dr. Cush reports financial ties with Pfizer, Abbvie, Amgen, BMS, Celgene, CORRONA, Genentech, IROKO Pharmaceuticals, Janssen Pharmaceutica Product, Novartis, Pfizer, UCB, and Vertex.
ACR 2013 Annual Meeting: Abstract 814. Presented October 27, 2013.
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Cite this: Tight Control Works in Psoriatic Arthritis, TICOPA Finds - Medscape - Nov 11, 2013.