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FDA approves infusible golimumab for treatment of RA patients

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The FDA has approved golimumab for infusion treatment in adults with moderate to severe rheumatoid arthritis in combination with methotrexate, Janssen Biotech announced.

Golimumab (Simponi Aria), the only fully human anti-tumor necrosis factor-alpha infusible therapy, has significantly improved signs and symptoms in adults with active rheumatoid arthritis (RA) who responded inadequately to methotrexate, according to a press release.

The approval was based on phase 3 trial results in which researchers evaluated 592 patients diagnosed with moderately to severely active RA who had at least six tender and six swollen joints at screening and baseline, had elevated C-reactive protein levels and had been receiving background methotrexate for at least 3 months, the release said. Three hundred ninety-five patients received approximately a 30-minute infusion of golimumab 2 mg/kg and methotrexate, while 197 patients received placebo plus methotrexate at weeks 0, 4 and then every 8 weeks. Proportion of ACR20 responders at week 14 was primary endpoint.

Fifty-nine percent of golimumab/methotrexate patients experienced improved signs and symptoms at week 14, compared with 25% of patients receiving placebo/methotrexate. Thirty percent of patients on the golimumab therapy achieved at least a 50% improvement in ACR criteria (ACR50) compared with 9% of placebo patients at primary endpoint. By week 24, all patients who had received placebo had crossed over to golimumab.

“At week 24, patients receiving Simponi Aria plus methotrexate had a mean change in total van der Heijde-Sharp (vdH-S) score of 0.03 from baseline, compared with a mean change of 1.09 in the placebo plus methotrexate group (P<.001),” according to the release. “At week 52, the mean change in total vdH-S score from baseline was 0.13 in Simponi Aria-treated patients vs. 1.20 in placebo patients who crossed over to Simponi Aria at either week 16 or 24.”

“Phase 3 data showed treatment with Simponi Aria plus methotrexate significantly improved signs and symptoms and physical function at week 24, and inhibited the progression of structural damage in patients with moderate to severe RA at weeks 24 and 52,” Sergio Schwartzman, MD, associate professor, Weill Cornell Medical College, and Janssen Biotech advisory board member, said in the release.