The first data from radiologic analyses in the phase 3 clinical trial of golimumab (Simponi, Centocor Ortho Biotech) for treatment of active psoriatic arthritis demonstrate the benefit of this new anti-TNF-alpha agent for inhibiting joint damage.
Philadelphia - The first data from radiologic analyses in the phase 3 clinical trial of golimumab (Simponi, Centocor Ortho Biotech) for treatment of active psoriatic arthritis demonstrate the benefit of this new anti-TNF-alpha agent for inhibiting joint damage.
The structural outcomes from the Golimumab – A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using Golimumab (GO-REVEAL) study and two phase 3 studies evaluating golimumab for the treatment of rheumatoid arthritis were presented at the 2009 annual scientific meeting of the American College of Rheumatology in Philadelphia.
Simponi was approved by the Food and Drug Administration in April 2009 for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
"Among patients with psoriatic arthritis treated with golimumab, there was essentially no progression of existing joint destruction," Dr. Mease says.
"These newest results add to the overall picture of the activity of golimumab as a highly effective option for improving all of the domains of psoriatic arthritis. Its benefits encompass signs and symptoms of joint disease, skin disease and enthesitis as well as function and quality of life, and they are achieved with the convenience of a once-a-month dosing regimen," he says.
The GO-REVEAL trial included 405 adult patients with active psoriatic arthritis. Eligible participants had at least three swollen and tender joints and active psoriatic skin lesions of at least 2 cm in diameter.
At baseline, patients were randomized to treatment with subcutaneous injections of placebo or golimumab 50 mg or 100 mg once every four weeks. The primary endpoint, ACR 20 response, was assessed at week 14, and at week 16, patients with an inadequate arthritis response were switched to golimumab 50 mg if they were receiving placebo, or golimumab 100 mg if they were in the lower-dose golimumab group. Beginning at week 24, all remaining placebo patients were treated with golimumab.
The effects of golimumab on structural damage were based on data collected at weeks 24 and 52 and measured using the van der Heijde-Sharp (vdH-S) score. This metric assesses radiographic damage to joints in the hands, wrists and feet, based on the amount of erosion and joint space narrowing.
At week 24, the mean change (± standard deviation) from baseline vdH-S among patients receiving golimumab 50 mg, the recommended dose for the treatment of psoriatic arthritis, was -0.16 ± 1.31 (a negative change indicates improvement), compared with worsening by +0.27 ± 1.26 in the placebo group (P = 0011, golimumab vs. placebo).
At week 52, the mean change from baseline vdH-S score among patients who had received golimumab since randomization was –0.22 ±1.64, while patients who had crossed over from placebo to golimumab at week 24 had an increase of 0.22 ± 1.38 from baseline, representing a decrease (improvement) of 0.05 from the week 24 visit.
"Twenty-four weeks is a relatively short period of treatment, but the effects of golimumab on vdH-S scores were already clinically as well as statistically significant. Stretched out over a period of years, one would expect to see progressive damage in patients not treated with an anti-TNF-alpha agent, but not among those continuing on golimumab. This type of sustained benefit has been established for older medications within the same class of biologics and will be analyzed for golimumab using data collected through two years of planned follow-up in the phase 3 trials," Dr. Mease says.
Dr. Mease says the radiologic data should underscore for rheumatologists, as well as dermatologists, the importance of ensuring that patients with psoriatic arthritis receive early and aggressive treatment because of the opportunity to inhibit structural damage.
"Progressive joint destruction with this disease and rheumatoid arthritis results in permanent, irreversible damage. Dermatologists should be teaming together with rheumatologists to be certain their patients with psoriatic arthritis are receiving appropriate therapy addressing all of their disease's domains," Dr. Mease says.
Disclosure: Dr. Mease is a consultant for Centocor, and Swedish Medical Center receives research grants from Centocor.