NEW YORK (Reuters Health) – Golimumab, a new anti-TNF monoclonal antibody, administered subcutaneously every 4 weeks, shows sustained efficacy in reducing signs and symptoms of active psoriatic arthritis through 52 weeks.
The findings come from a continuation of the GO-REVEAL trial, for which earlier results have been reported previously. “Significant inhibition of structural damage at week 24 and maintenance of radiographic benefit and improved physical function through 1 year were also observed,” comment the authors of the current study reported in Arthritis & Rheumatism online February 29.
Dr. Arthur Kavanaugh, with the University of California, San Diego, in La Jolla, and colleagues explain that after week 24, participants in the trial who started on placebo were crossed over to 50 mg golimumab while those who had shown an inadequate response had their dose increased. “Thus, all study participants received blinded golimumab 50mg or 100mg every 4 weeks from week 24 forward.”
The investigators found that mean changes from baseline to 24 weeks in the modified Sharp/van der Heijde score (SHS), which were not reported previously, were significantly different with golimumab 50 mg versus placebo (-0.16, p=0.011) and with combined golimumab 50 mg and 100 mg results (-0.09, p=0.015).
Radiographic studies conducted through week 24 indicated inhibition of structural damage in golimumab-treated patients, the authors note. “Radiographic data through week 52 demonstrated maintenance of radiographic benefit among golimumab-treated patients, as well as some improvement in the total PsA-modified SHS among patients who crossed over from placebo to active treatment at week 24,” they report
As for safety, the most common adverse effects in golimumab-treated patients were upper respiratory tract infection and nasopharyngitis. Overall, 14 (4%) golimumab-treated patients discontinued because of an adverse event, Dr. Kavanaugh and colleagues note.
Summing up, they conclude, “Golimumab efficacy was not substantially different between patients receiving 50 mg versus 100 mg and was comparable to that observed with other commercially available anti-TNF agents. Golimumab safety was also consistent across both doses and with other anti-TNF agents.”
Golimumab, a human TNF-alpha antibody, administered every 4 weeks as a subcutaneous injection in psoriatic arthritis: Clinical efficacy, radiographic, and safety findings through 1year of the randomized, placebo-controlled, GO-REVEAL® study