EULAR 2009: Golimumab Benefits Hold Up for 2 Years in Psoriatic Arthritis

Alice Goodman

June 16, 2009

June 16, 2009 (Copenhagen, Denmark) — The benefits of golimumab reported at 24 weeks by patients with psoriatic arthritis in the GO-REVEAL study persisted at 2 years, according to the results of a 104-week open-label extension phase of the original randomized controlled double-blind study.

"The take-home messages from this trial are that golimumab works in patients with psoriatic arthritis and response is sustained," said lead investigator Arthur Kavanaugh, MD, from the University of San Diego in California.

Older treatments for psoriatic arthritis include methotrexate, cyclosporine, and leflutamide. However, data from large registries have shown that tumor necrosis factor (TNF)-alpha agents, such as golimumab, which was recently approved by the US Food and Drug Administration, are more potent, Dr. Kavanaugh explained.

GO-REVEAL randomly assigned patients with active psoriatic arthritis to subcutaneous injections with golimumab 50 mg (146 patients), golimumab 100 mg (146 patients), or placebo (113 patients). Patients were treated every 4 weeks for 20 weeks.

At 24 weeks, golimumab was found to be superior to placebo, improving active psoriatic arthritis and associated skin and nail psoriasis. The study, presented here at EULAR 2009: The Annual European Congress of Rheumatology, was a follow-up of patients who remained in the original study for a total of 104 weeks (including 24 weeks of the double-blind phase). There were 3 groups of patients: those assigned to and remaining on golimumab 50 mg (n = 70), those who switched from golimumab 50 to 100 mg during the trial (n = 76), and those assigned to and remaining on golimumab 100 mg dose (n = 130).

At 2 years, 64 of 70 patients treated with golimumab 50 mg, and 95 of 130 treated with golimumab 100 mg achieved at least a 20% improvement in American College of Rheumatology score (ACR20). Of the 76 patients randomized to 50 mg who switched to the 100 mg dose in "early escape," 43 achieved ACR20. Improvement of 50% (ACR50) was documented in 47 of 70 patients taking golimumab 50 mg and in 70 of 130 taking golimumab 100 mg. A 70% improvement in ACR score (ACR70) was observed in 31 of 70 patients taking the 50 mg dose and in 48 of 130 taking the 100 mg dose.

Sustained improvement in skin manifestations was also seen over the 2-year period. Of 296 patients with psoriasis skin involvement of 3% or greater body surface area at baseline, 200 were evaluable at 2 years. At least a 75% improvement on the Psoriatic Area and Severity Index (PASI 75) was observed in 33 of 48 patients remaining on golimumab 50 mg and in 73 of 96 patients remaining on the 100 mg dose throughout the study period. Of the 56 patients who switched from the 50 to the 100 mg dose for early escape, 35 achieved PASI 75.

Dr. Kavanaugh said that golimumab was generally well tolerated, with a safety profile similar to that of other anti-TNF-alpha agents used to treat psoriatic arthritis.

Humanized Antibody

"Golimumab is a humanized antibody, which is a version of the chimeric antibody infliximab," explained Edward Vital, MD, from the University of Leeds in the United Kingdom.

After a few months or years of a good response to infliximab, the response wears off, presumably because of the development of antibodies to the chimeric antibody (ie, secondary nonresponse), Dr. Vital explained.

"Golimumab appears to [eliminate] the secondary nonresponse associated with infliximab, but longer-term follow-up is needed," Dr. Vital commented.

The GO-REVEAL trial was supported by Centocor. Dr. Vital has received speaker's honoraria from Roche.

EULAR 2009: The Annual European Congress of Rheumatology: Abstract OP-0195. Presented June 11, 2009.

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