Seattle — Results available from one year of follow-up in a phase 3 clinical trial show that subcutaneous injections of the investigational anti-tumor necrosis factor (TNF) monoclonal antibody agent golimumab (Simponi, Centocor), administered with a convenient, once-a-month dosing schedule, provides durably effective treatment for psoriatic arthritis with an acceptable safety profile.

Simponi was approved for marketing in the United States for moderate-to-severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis at the end of April.

The phase 3 trial, known as GO-REVEAL (Golimumab – A Randomized Evaluation of Safety and Efficacy in Subjects with Psoriatic Arthritis Using a Human Anti-TNF Monoclonal Antibody), is the largest-ever phase 3 study of a biologic agent for the treatment of psoriatic arthritis.

The study enrolled 405 patients with psoriatic arthritis who were randomized into one of three groups to receive golimumab 50 mg, golimumab 100 mg, or placebo at baseline and then once every four weeks.

Patients in the placebo and golimumab 50 mg groups who had an inadequate response at week 16 were switched to treatment with golimumab 50 mg and 100 mg, respectively, and all remaining placebo-treated patients were crossed over to golimumab 50 mg at week 24.

At one year, about three-fourths of patients in both golimumab dosage groups achieved an American College of Rheumatology (ACR) 20 response (20 percent improvement in ACR criteria), and more than half achieved an ACR 50 response. An ACR 70 response was achieved by 43 percent of patients receiving golimumab 50 mg and by 31 percent of those in the higher-dose group.

The inclusion criteria for the phase 3 trial required patients to have at least three swollen and tender joints and active plaque psoriasis with a lesion at least 2 cm in diameter.

Existing treatment with stable doses of methotrexate, low-dose corticosteroids, or NSAIDs was allowed, but patients were excluded if they had received any treatment with a biologic agent in the previous three months.


Benefits of golimumab treatment were also seen in other efficacy endpoints, including improvements in health-related quality of life, responses in the Disease Activity Score 28, Psoriasis Area and Severity Index (PASI) scores, and indices rating severity of nail disease, enthesitis and dactylitis. No safety signals emerged with treatment through one year.

"GO-REVEAL results reported at the ACR meeting in 2007 demonstrated statistically significant benefits of golimumab after completion of the placebo-controlled portion of the trial at week 24.

"The current analyses are based on a more complete data package with follow-up to 52 weeks, and the results show that earlier responses are sustained, and golimumab continues to have a favorable safety profile," says Philip J. Mease, M.D., lead study investigator and research director, Swedish Medical Center, Seattle, and clinical professor of medicine, University of Washington School of Medicine, Seattle.


Skin disease responses were assessed in patients with psoriasis at baseline affecting greater than 3 percent of their body surface area. Mean PASI scores at baseline ranged from 8.4 to 11.1 across the three study groups.

At week 24, PASI 75 responder rates were 56 percent in the golimumab 50 mg group, 66 percent for patients treated with the 100 mg dose, and only 1.4 percent among the placebo-treated controls.

At one year, 62 percent of patients treated with golimumab 50 mg and 69 percent in the 100 mg group achieved a PASI 75 response.

The Health Assessment Questionnaire, Short Form 36, and a visual analogue scale rating of self-reported productivity were used to evaluate changes in physical function, mental function, and other domains of health-related quality of life.

Analyses of data collected at various intervals throughout the trial showed there were clinically meaningful benefits of treatment with golimumab, statistically significant differences favoring golimumab over placebo, and increasing improvements as the duration of golimumab treatment lengthened. A benefit was also recorded for a reduction in time lost from work for caregivers comparing the golimumab-treated patients and control group at week 24.

"The findings from these comprehensive evaluations show golimumab benefits multiple aspects of psoriatic arthritis and has a meaningful impact on the lives of patients and those who care for them," Dr. Mease tells Dermatology Times.
Adopted from the News Provided by DermatologyTimes