Treat-to-target approach brought significant improvement to psoriatic arthritis patients

SAN DIEGO — By using a treat-to-target approach, there was a significant improvement to joint and skin outcomes for patients newly diagnosed with psoriatic arthritis, according to research presented at the American College of Rheumatology annual meeting.

“This study is the first and only study to show that treat-to-target can work in psoriatic arthritis, and that we can improve outcomes for patients by aiming for objective criteria, which have now been developed and validated,” researcher Laura C. Coates, MD, PhD, NIHR clinical lecturer, University of Leeds, told Healio.com. “It’s a relatively simple way of improving outcomes with the drugs we already have available to us. We’ve shown a benefit to patients in varying aspects of the disease.”

Laura C. Coates

In a multicenter, open label, randomized controlled trial, researchers in the United Kingdom studied 206 patients (71% with polyarthritis; median age, 45 years; 52% men) with early disease-modifying antirheumatic disease (DMARD)-naive psoriatic arthritis (PsA; less than 24-month duration). One hundred one patients received tight control (TC; review every 4 weeks) and 105 patients, standard care (StdC; review every 12 weeks) for 48 weeks.

A strict treatment protocol, including escalation of therapy if minimal disease activity (MDA) criteria were not met, was conducted for the TC patients, who began methotrexate with rapid escalation to 25 mg after 6 weeks if tolerated. If MDA was not met after 12 weeks, patients were placed on DMARD combination therapy. If patients had at least three tender or swollen joints after 12 additional weeks, they were escalated to anti-TNF therapy; if they were not in MDA but had less than three active joints, they received an alternative DMARD with methotrexate.

StdC patients were treated by a rheumatologist, and had no set protocol or limitations.

ACR20 response at 48 weeks was the primary outcome, with ACR50 and ACR70 at 48 weeks included in secondary outcomes. Multivariate logistic regression, adjusting for arthritis classification and treatment center, were used to compare arms.

Twelve patients (five TC, seven StdC) withdrew by week 48 and 12 (six TC, six StdC) were lost to follow-up. The TC cohort had a greater odds of achieving ACR20 at 48 weeks compared with the StdC cohort in the intention-to-treat population (OR=1.91; 95% CI, 1.03-3.55). Patients in the TC cohort also had greater odds of reaching ACR50 and ACR 70 (OR=2.36; 95% CI, 1.25-4.47; OR=2.64; 95% CI, 1.32-5.26, respectively) compared with StdC patients.

Nausea, liver function test abnormalities and infections were the most commonly reported adverse events, with AEs reported in 88% of patients (97% TC vs. 80% StdC). Twenty patients (14 TC, six StdC) reported 33 serious adverse events (SAEs), with no deaths reported.

Disclosure: Researcher Philip G. Conaghan, MD, PhD, reports consulting fees or other renumeration from Pfizer and Janssen Pharmaceuticals and being among the speakers’ bureau for Bristol-Myers Squibb and Pfizer. Philip S. Helliwell, FRCP, PhD, reports consulting fees or other renumeration from Pfizer.

For more information: Coates LC. #814: Results of a Randomized Controlled Trial Comparing Tight Control of Early Psoriatic Arthritis (TICOPA) With Standard Care: Tight Control Improves Outcome. Presented at: the 2013 American College of Rheumatology Annual Meeting; Oct. 26-30, San Diego.