Tofacitinib improves enthesitis in psoriatic arthritis regardless of baseline severity
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Key takeaways:
- Patients receiving tofacitinib had fewer enthesitis relapses following initial resolution after 1 or 3 months.
- Enthesitis remains a vital target when treating patients with psoriatic arthritis.
Tofacitinib improves enthesitis in patients with psoriatic arthritis regardless of severity or location at baseline, according to data published in Arthritis Research and Therapy.
“Patients with vs. without enthesitis generally reported worse functional status, greater fatigue and pain, and reduced work productivity,” Philip J. Mease, MD, of the University of Washington and Swedish Medical Center, in Seattle, and colleagues wrote. “When deciding on treatment strategies for PsA, enthesitis has been recognized as an important domain to be considered.
“Efficacy and safety of tofacitinib 5 mg twice daily (BID; recommended dosage) and 10 mg BID have been demonstrated in two phase 3 studies of patients with active PsA, and in an open-label, long-term extension study,” they added. “In the two phase 3 studies, tofacitinib treatment was associated with greater improvements in enthesitis vs. placebo by month 3.”
To investigate the impact of tofacitinib (Xeljanz, Pfizer) on enthesitis, based on location and severity at baseline, in patients with PsA, Mease and colleagues performed a post hoc analysis of data from the OPAL Broaden and OPAL Beyond phase 3 studies. Patients in OPAL Broaden received 5 mg or 10 mg of tofacitinib, adalimumab 40 mg infusions or placebo. In OPAL Beyond, patients who demonstrated inadequate responses to TNF inhibitors received tofacitinib 5 mg, tofacitinib10 mg or placebo.
Patients who received placebo transitioned to tofacitinib 5 mg or 10 mg after 3 months. Patients in each study also received a background dose of a conventional synthetic disease-modifying antirheumatic drug.
Both source studies identified the presence of enthesitis at baseline and at months 1, 3 and 6 using the Leeds Enthesitis Index (LEI) and the Spondyloarthritis Research Consortium of Canada Enthesitis Index (SPARCC). LEI and SPARCC scores were assigned for each site of investigation, with 0 indicating no tenderness and 1 indicating tenderness. Patients were grouped depending on whether they demonstrated enthesitis at baseline, with severity defined based on the number of afflicted sites. The researchers measured disease activity as well as patient-reported outcomes, including the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT – F) total score.
The analysis included 710 patients. Of those, 479 demonstrated a baseline LEI greater than 0, while 545 patients had a SPARCC score greater than 0. A total of 136 patients demonstrated a score of 0 in both indexes at baseline. Among patients with an LEI score greater than 0, the average enthesitis severity scores ranged from 1 to 4.4. Meanwhile, in those with a SPARCC score than 0, the average was 1.3 to 9.4. Patients who received tofacitinib demonstrated greater changes in both indexes from baseline compared with placebo.
After 6 months, 40% or fewer patients who demonstrated a baseline score greater than 0, but whose enthesitis resolved by months 1 or 3, experienced a relapse at 6 months. Additionally, it was more common to see patients reach remission or low disease activity if they received tofacitinib, according to the reseearchers.
“This post hoc analysis demonstrated greater improvements from baseline in enthesitis and disease activity measures in patients with PsA receiving tofacitinib vs. placebo across several enthesitis locations and with varying enthesitis severity at baseline,” Mease and colleagues wrote.
“An association between enthesitis at the lateral epicondyle humerus and Achilles tendon insertion and improvement in pain, and an association between enthesitis severity (assessed by SPARCC) and improvements in fatigue and pain were identified,” they added. “These findings support tofacitinib as a treatment option for patients with PsA with enthesitis and affirm the importance of addressing enthesitis in the PsA treatment paradigm.”
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