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July 18, 2013 /PRNewswire/ -- Janssen Biotech, Inc. announced today the U.S. Food and Drug Administration (FDA) approval of SIMPONI
TM (golimumab) for infusion for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate. SIMPONI ARIA, the only fully-human anti-tumor necrosis factor (TNF)-alpha infusible therapy, has been shown to significantly improve signs and symptoms and physical function, and inhibit the progression of structural damage. The SIMPONI ARIA dose regimen is 2 mg/kg given as an intravenous infusion at weeks 0 and 4, then every 8 weeks thereafter. The infusion is given over a 30-minute period, providing a short infusion time for patients. Approximately 1.3 million people in
the United States are living with RA,[i] a chronic, systemic inflammatory condition that is often characterized by symptoms that include pain, stiffness and inflammation, and in some cases, joint destruction and disability.[ii]
"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 week 24 and 52," said
Sergio Schwartzman*, MD, Director, Inflammatory Arthritis Center, Hospital for Special Surgery, Associate Professor, Weill Cornell Medical College, and advisory board member. "The approval of SIMPONI ARIA offers rheumatologists a new anti-TNF infusible treatment for patients who demonstrate an inadequate response to methotrexate; having treatment options remains critical for us to continue to meet the needs of our patients."
The approval is supported by findings from the Phase 3 Trial of
Golimumab, an Anti-TN
F-alpha Monoclonal Antibody, Administered Intraveno
usly, in Subjects with Active
rexate Therapy (GO-FURTHER) trial, which 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 (CRP) levels at screening and who had been receiving background methotrexate for at least three months.
Results from the trial revealed 59 percent (n = 231/395) of patients receiving treatment with SIMPONI ARIA plus methotrexate versus 25 percent of patients receiving placebo plus methotrexate (n = 49/197) (a difference with 95 percent CI 25.9, 41.4) experienced significant improvements in signs and symptoms at week 14, as demonstrated by at least 20 percent improvement in American College of Rheumatology criteria (ACR 20), the study's primary endpoint. A higher proportion of patients receiving SIMPONI ARIA plus methotrexate achieved at least a 50 percent improvement in ACR criteria (ACR 50) compared with patients receiving placebo plus methotrexate at week 14 (30 percent versus 9 percent, respectively, a difference with 95 percent CI 15.3, 27.2). Significant improvements in ACR 20 were observed as early as week 2, after a single SIMPONI ARIA infusion, as 33 percent of patients achieved an ACR 20 response versus 12 percent of patients receiving placebo. Radiographic progression of the hands and feet were assessed by the change from baseline in van der Heijde-Sharp (vdH-S) scores, an X-ray measure of joint destruction, including joint erosion and joint space narrowing in which higher scores indicate greater structural damage. At week 24, patients receiving SIMPONI ARIA plus methotrexate had a mean change in total vdH-S score of 0.03 from baseline, compared with a mean change of 1.09 in the placebo plus methotrexate group (P<0.001). At week 52, the mean change in total vdH-S score from baseline was 0.13 in SIMPONI ARIA treated patients versus 1.20 in placebo patients who crossed over to SIMPONI ARIA at either week 16 or 24.
"SIMPONI ARIA demonstrated a compelling efficacy profile in the treatment of moderately to severely active rheumatoid arthritis in the GO-FURTHER study," said
Jerome A. Boscia, M.D., Vice President, Head of Immunology Development, Janssen Research & Development, LLC. "The approval of SIMPONI ARIA represents our commitment to bringing forward new therapeutic options for patients living with immunological diseases, including potentially disabling diseases like rheumatoid arthritis."
"As leaders in rheumatology, we're proud to expand our treatment portfolio by making an anti-TNF infusible medicine like SIMPONI ARIA available to patients," said
Rob Bazemore, President,
Janssen Biotech, Inc. "Treatment with SIMPONI ARIA provides a different infusion experience; patients can now receive this form of treatment administration with an anti-TNF therapy via a short infusion time of 30 minutes with a dosing regimen of every 8 weeks."
The GO-FURTHER trial is a Phase 3, international multicenter, double-blind, placebo-controlled study including 592 adults with RA designed to compare ACR 20 response at week 14 in patients receiving an I.V. golimumab infusion plus methotrexate compared with patients receiving placebo infusions plus methotrexate. The trial included patients diagnosed with moderately to severely active RA who had at least six tender and six swollen joints at screening and baseline, had elevated CRP levels at screening and who had been receiving background methotrexate for at least 3 months. Patients were randomized 2:1 to receive a 30 (+/- 10) minute I.V. infusion of golimumab 2 mg/kg or placebo at weeks 0, 4, and then every 8 weeks; in both treatment arms, methotrexate was taken. The primary endpoint of the study was the proportion of ACR 20 responders at week 14. At week 16, patients receiving placebo with less than 10 percent improvement in combined swollen and tender joint counts from baseline qualified for early escape and received I.V. golimumab 2 mg/kg infusions at week 16 and week 20 and every 8 weeks subsequent; patients receiving golimumab who qualified for early escape remained on their golimumab therapy. All patients receiving placebo crossed over to I.V. golimumab at week 24. Radiographs of the hands and feet were taken at baseline, week 24 (week 16 for early escape participants regardless of whether they had been randomized to placebo or golimumab) and week 52, and were scored using the van der Heijde-Sharp (vdH-S) score.