Golimumab Phase III Clinical Trials Show Promising Results

Centocor, a pharmaceutical company, issued two press releases on June 11, touting the positive results of its new TNF-inhibitor drug golimumab in three separate Phase III clinical trials.  The results of the trials may help Centocor and Schering-Plough (working together to develop and market the drug) to move closer to receiving FDA approval for the drug for the treatment of Rheumatoid Arthritis, psoriatic arthritis and ankylosing spondylitis.

Centocor claims that all three studies show that patients taking golimumab experienced significant improvements in the signs and symptoms of RA, increased physical function and a decrease in disease activity. Golimumab is a TNF-inhibitor drug that is administered by subcutaneous injection once every four weeks in dosages of either 50 mg or 100mg.  In each of the three studies, patients were also receiving methotrexate (MTX), sulfasalazine (SFZ) or hydrochloroquine(HCQ).  The difference between the three studies was whether patients had previously taken MTX (the GO-FORWARD trial), had not previously taken MTX (GO-BEFORE trial) or if they had previously taken another TNF-inhibitor drug (GO-AFTER trial). 

GO-FORWARD

In the GO FORWARD study, GOlimumab FOR subjects With Active RA Despite MTX, patients whose disease was active despite ongoing treatment with MTX received either 50 mg or 100 mg doses of golimumab were studied in patients. It was a multi-center clinical trial that included 444 adult patients with active RA and more than four tender and swollen joints, despite MTX therapy.  After 14 weeks of treatment, a little over 50 percent of patients receiving each dosage gained at least 20 percent improvement in signs and symptoms of RA (ACR 20), compared to 33 percent of patients receiving placebo and MTX.  After this same time, about 75 percent of each group of golimumab patients were classified as DAS28 responders, meaning they had decreased disease activity, compared with 52 percent of patients receiving MTX alone.  And about 34 percent of patients in the golimumab groups achieved remission compared with 13 percent of patients receiving placebo plus MTX. 

After 24 weeks, about 70 percent of patients receiving golimumab experienced clinically relevant improvement in physical function, compared with 39 percent of patients receiving placebo plus MTX. The assessment of physical function was based on the degree of difficulty a patient has in accomplishing tasks in eight functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and other activities of daily living).  Patients in the 100mg group had slightly higher percentages for improvement of all areas-signs, symptoms, disease activity and physical function than patients in the 50mg group. Centocor claims that patients experienced improvement early on in treatment (the first progress assessment was at week 4) and that they continued to improve over time through six months.