Golimumab Improves Long-Term Clinical Outcomes in Ankylosing Spondylitis

By Will Boggs MD

NEW YORK (Reuters Health) - Golimumab, given every four weeks, improves long-term clinical outcomes in patients with ankylosing spondylitis (AS), according to results from the GO-RAISE phase 3 clinical trial.

"There were no surprises as far as drug safety or efficacy was concerned," Dr. Atul Deodhar from Oregon Health & Science University in Portland told Reuters Health by email. "Golimumab, like other TNF inhibitors, should fit after NSAIDs have failed to produce enough benefit to the patient."

Dr. Deodhar and colleagues in the GO-RAISE trial investigated the effects of golimumab administered subcutaneously every four weeks in 355 patients with active ankylosing spondylitis.

At week 24, 62% of patients treated with golimumab achieved ASAS20 responses and 47% achieved ASAS40 responses, the researchers report in Annals of the Rheumatic Diseases, online November 11.

Just over a quarter of patients discontinued golimumab before the 252-week assessment. By week 256, 66% of patients treated with golimumab had achieved ASAS20 responses and 57% had achieved ASAS40 responses. A third of the patients achieved ASAS partial remission at week 256.

Among the 54 patients who escalated their golimumab doses from 50 mg to 100 mg, 39% achieved ASAS20 responses and 30% achieved ASAS40 responses.

Improvements in health-related quality of life early in the trial were sustained with up to five years of golimumab treatment, according to the researchers.

"Close to 20% of patients stayed in the trial for 5 years despite not receiving ASAS20 response," Dr. Deodhar said. "This number is also not different from other trials of long duration. We have tried to analyze the reasons why these patients stay in the trial even though the conventional outcome measures suggest that they have received minimal benefits."

One in five patients experienced serious adverse events through week 268, including most commonly osteoarthritis requiring hospitalization, pneumonia, worsening of AS and depression.

"Taken together," the researchers conclude, "results reported here indicate that clinical improvements observed in patients with AS treated with golimumab through week 24 were sustained through up to 5 years of treatment. Importantly, no new safety signals were detected, and the golimumab benefit-risk profile remains positive."

Jansen Research & Development and Merck/Schering-Plough Research Institute funded the trial, employed half of the authors and had various relationships with the rest.

SOURCE: https://bit.ly/1xxRV6X

Ann Rheum Dis 2014.

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