A long-acting monoclonal antibody to TNF-alpha, golimumab, is effective in treating patients with active rheumatoid arthritis despite treatment with methotrexate, according to a report in the April issue of Arthritis & Rheumatism.
"Golimumab has a longer biological effect, which allows once monthly administration instead of weekly or every other week dose administration," Dr. Jonathan Kay told Reuters Health. "To date, based on phase 1, 2, and initial phase 3 data, golimumab appears effective and well-tolerated."
Dr. Kay from Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts and colleagues assessed the efficacy, safety, and pharmacokinetics of subcutaneous administration of 50 or 100 mg golimumab versus placebo at 2- or 4-week intervals in 172 patients with rheumatoid arthritis who had an inadequate response to methotrexate.
A significantly greater proportion of patients given golimumab plus methotrexate than those given methotrexate plus placebo achieved ACR20, ACR50, or ACR70 responses at week 16, the authors report.
These responses were observed as early as week 2 and were maintained through week 52, the investigators say.
"At week 20, patients who had been receiving golimumab injections every 2 weeks switched to injections every 4 weeks without an appreciable decrease in the proportion of ACR20 responders," Dr. Kay and colleagues report.
Similar percentages of patients in the golimumab and placebo groups reported adverse events, with most events rated as mild or moderate in severity.
There were no cases of tuberculosis or lymphoma, and there were no deaths during the 52-week study. Three golimumab-treated patients and two patients in the placebo group reported serious infections.
Nearly 20% of the golimumab-treated patients eventually developed antibodies to golimumab, the researchers note, but their presence did not appear to interfere with a therapeutic response to golimumab.
Twenty-one percent of patients in the golimumab group and 18% of patients in the placebo group developed antinuclear antibodies, but none of these patients had clinical syndromes such as a lupus-like syndrome.
"Golimumab is being developed for both subcutaneous and intravenous administration," Dr. Kay explained. "Physicians and patients will have the option to induce control of rheumatoid arthritis disease activity with an intravenous formulation and to maintain control of disease activity with a subcutaneous formulation. Flares could be treated with intermittent courses of intravenous golimumab, if necessary. This flexibility in route of administration may offer better control of the waxing and waning activity of rheumatoid arthritis."
"Phase 3 trials of golimumab are ongoing in patients with psoriatic arthritis and ankylosing spondylitis, as well as in patients with various stages of rheumatoid arthritis," Dr. Kay added.
Arthritis Rheum 2008;58:964-975.
hi lynn i read about golimumab a while ago .. it is lookng pretty good
so far.. cost of med remains to be seen..
untill we see these meds in tablet form ...which is only matter of time...
costs are going to be held high
Boney
I think it looks pretty good too. I continue to have good results with Rituxan, but it's nice to know that there are new meds coming....The problem for me and others is qualifying for them.
being on pred..
Boney
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