Centocor, Inc (HORSHAM, Pennsylvania), a wholly owned subsidiary of Johnson & Johnson, announced that more than half of patients receiving monthly subcutaneous (SC) injections of golimumab 50 mg and 100 mg experienced significant and sustained improvements in the signs and symptoms of active ankylosing spondylitis (AS), according to the phase III study (GO-RAISE trial) results. The GO-RAISE trial included 356 active AS patients who were randomized to receive SC injections of golimumab 50 mg, 100 mg, or placebo every 4 weeks. At week 16, two patient groups demonstrating <20% improvement from baseline in total back pain and morning stiffness measures were switched from placebo to golimumab 50 mg or from golimumab 50 mg to 100 mg. At week 14, 59% of patients receiving golimumab 50 mg and 60% receiving golimumab 100 mg achieved at least 20% improvement in the Assessment in Ankylosing Spondylitis criteria (ASAS20), the primary endpoint of the study, compared with 22% of patients receiving placebo (P <.001 for both comparisons). Study subjects given golimumab 50 mg or 100 mg showed significant and sustained improvements in physical function through 6 months as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI).

As early as week 4, after one dose, clinical benefit was demonstrated and maintained through week 24, at which time, 56% of patients given golimumab 50 mg and 66% given 100 mg achieved ASAS20 compared with 23% of patients on placebo (P <.001 for both comparisons). Also at week 24, 51% of patients receiving golimumab 50 mg and 48% receiving 100 mg achieved a 50% reduction in disease activity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50) compared with 15% on placebo (P <.001); 44% of patients receiving golimumab 50 mg and 54% receiving 100 mg achieved ASAS40 compared with 15% of patients receiving placebo (P <.001 for both comparisons).

Golimumab-treated patients experienced significant functional improvements as measured by the BASFI; 50 mg and 100 mg patient groups experienced an average decrease of 1.4 and 1.5 units from baseline in BASFI score, respectively, at week 14, compared with an average increase of 0.1 units among patient given placebo (P <.001 for both comparisons). Through week 24, golimumab was generally well tolerated, with an increased incidence of infections, primarily upper respiratory infections. Antibodies to golimumab were detected in 4% of patients through week 24.

Golimumab, Centocor Inc, and Schering-Plough Corp's human anti-TNFα monoclonal antibody (which neutralizes both the soluble and membrane-bound forms of TNFα), is currently in the most comprehensive phase III development program to date for an anti-TNFα biologic therapy. Golimumab is being studied as a monthly SC injection and an every 12-week intravenous (IV) infusion (~30-min) therapy for the treatment of rheumatoid arthritis, psoriatic arthritis and AS.

Centocor discovered golimumab and has exclusive marketing rights to the agent in the US. Schering-Plough has exclusive marketing rights outside the US except in Japan, Indonesia, and Taiwan where golimumab will be comarketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; in Hong Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and in China where golimumab will be exclusively marketed by Xian-Janssen.