Golimumab Improves Rheumatoid Arthritis
Posted 6/13/08
Findings from two new Phase 3 studies showed that patients receiving every four-week subcutaneous injections of golimumab and weekly methotrexate (MTX) experienced significant improvements in the signs and symptoms of rheumatoid arthritis (RA) as well as in physical function and disease activity. Some patients achieved remission as measured by Disease Activity Score (DAS28). Findings from two multicenter, randomized, double-blind, placebo-controlled Phase 3 studies showed the efficacy of golimumab in two important populations: MTX-naive patients and patients with active RA despite ongoing treatment with MTX. These data were presented at the European League Against Rheumatism (EULAR) Annual Congress of Rheumatology.
In the study, both 50-mg and 100-mg doses of golimumab were studied in patients whose disease was active despite ongoing treatment with MTX. At week 14, 55 percent of patients receiving golimumab 50 mg plus MTX and 56 percent receiving golimumab 100 mg plus MTX achieved at least 20 percent improvement in signs and symptoms of RA, compared to 33 percent of patients receiving placebo and MTX. Improvements were seen as early as four weeks after the first golimumab injection, and generally continued to improve over time.
"The data in this study demonstrate that golimumab is beneficial in improving numerous disease parameters, including inducing remission, in patients whose disease was active despite ongoing treatment with methotrexate," said Edward Keystone, MD, FRCPC, director of the Rebecca MacDonald Centre for Arthritis & Autoimmune Disease at Mount Sinai Hospital in Toronto, and lead study investigator. "Since some patients do not respond adequately to methotrexate alone, this combination therapy could prove to be a highly valuable treatment option based on these results."
Patients receiving golimumab also experienced improvement in physical function as assessed by the Health Assessment Questionnaire (HAQ) and disease activity as measured by the DAS28. Importantly, 35 percent and 32 percent of patients in the respective golimumab groups achieved remission based on DAS28, compared with 13 percent of patients receiving placebo plus MTX. These improvements were sustained through six months.
In another Phase 3 study, MTX-naïve patients treated with golimumab 50 mg or 100 mg in combination with MTX experienced improvement in signs and symptoms of arthritis as well as in disease activity.
In the primary analysis of the combined group of patients receiving either golimumab 50 mg or 100 mg in combination with MTX, 38 percent achieved at least 50 percent improvement in signs and symptoms of RA through week 24, compared with 29 percent of patients receiving placebo plus MTX.
"These data show that treatment with golimumab induces an important depth of response, improving multiple aspects of rheumatoid arthritis and leading to significant decreases in disease activity," said Roy Fleischmann, MD, Clinical Professor, Department of Internal Medicine at the University of Texas Southwestern Medical Center; Chief, Division of Rheumatology at St. Paul University Hospital in Dallas, Texas and lead study investigator. "Golimumab, which is an anti-TNF therapy, is a promising treatment option for multiple patient populations with this chronic and potentially debilitating inflammatory disease."
Also at week 24, patients receiving golimumab plus MTX experienced improvements in disease activity as measured by DAS28.
This article was adapted from a press release issued by Centocor.
