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J&J's (JNJ) Janssen Reports Significant Phase 3 Data from Golimumab on Radiographic Progression in RA Patients

November 12, 2012 8:23 AM EST
Johnson & Johnson's (NYSE: JNJ) Janssen Research & Development reported new Phase 3 data from a Janssen-sponsored study showed treatment with the investigational intravenous (I.V.) therapy golimumab, a tumor necrosis factor (TNF) inhibitor, significantly inhibited radiographic progression in patients with active moderate to severe rheumatoid arthritis (RA) despite treatment with methotrexate. Analysis of study patients' X-rays showed significant inhibition of the progression of structural damage at week 24 in greater proportions of patients receiving I.V. golimumab plus methotrexate compared with patients receiving placebo plus methotrexate. The inhibition of structural damage progression was maintained in patients randomized to I.V. golimumab through week 52, and inhibition of structural damage progression was observed at week 52 in patients receiving placebo who crossed over to I.V. golimumab at week 24. Treatment with I.V. golimumab plus methotrexate also led to improvements in signs and symptoms and disease activity with nearly 60 percent of patients achieving at least a 20 percent improvement in the American College of Rheumatology (ACR 20) score at week 14, the study's primary endpoint, and nearly two-thirds of patients achieving that response at week 52. These data are being presented at the 2012 Annual Meeting of the American College of Rheumatology.

In September, Janssen announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting approval of I.V. golimumab in combination with methotrexate for the treatment of adults with moderately to severely active RA. Golimumab is currently marketed as SIMPONIĀ® (golimumab), a subcutaneous injection approved by the United States Food and Drug Administration (FDA) for the treatment of moderately to severely active RA with the medicine methotrexate, active psoriatic arthritis alone or with the medicine methotrexate and active ankylosing spondylitis.

n the Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNF-alpha Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy (GO-FURTHER), patients were randomized to receive I.V. golimumab 2 mg/kg or placebo, via a 30-minute infusion, plus methotrexate at weeks 0, 4 and then every 8 weeks. Non-responders to placebo at week 16 were crossed over to receive I.V. golimumab, and all remaining patients receiving placebo crossed over at week 24. Radiographic progression was 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 I.V. golimumab had a mean change (+/- standard deviation) in total vdH-S score of 0.03 (+/-1.90) from baseline, compared with a mean change of 1.09 (+/- 3.19) in the placebo group (P < 0.001). At week 52, patients who received the 52-week regimen of I.V. golimumab had a mean change of 0.13 (+/- 3.11) from baseline, compared with a mean change of 1.22 (+/- 3.98) in patients who crossed over from placebo to I.V. golimumab during the trial (P < 0.001). Patients randomized to I.V. golimumab and those in the crossover group had a mean change in total vdH-S score of 0.15 (+/- 1.83) and 0.12 (+/- 2.44), respectively, from week 24 to 52, supporting inhibition of structural damage progression in all patients receiving I.V. golimumab.

Significant proportions of patients receiving I.V. golimumab also demonstrated improvements in signs and symptoms compared with patients receiving placebo according to ACR scores, European League Against Rheumatism (EULAR)/Disease Activity Score (DAS) 28 C-reactive protein (CRP) response criteria and Health Assessment Questionnaire (HAQ) disability scores at weeks 14 and 24. A majority of those patients who achieved ACR 20, ACR 50, ACR 70 and EULAR/DAS 28 CRP good/moderate response by week 24 maintained response through week 52 (82 percent of ACR20 responders; 71.7 percent of ACR 50 responders; 60.9 percent of ACR 70 responders; 80 percent demonstrating DAS28-CRP good/moderate response). The EULAR/DAS 28 CRP is a measure of disease activity in patients with RA that is calculated by assessing the number of tender and swollen joints (among a total of 28), serum CRP level (indicator of inflammation), and the patient's assessment of global health.

Through week 52 of the GO-FURTHER trial, the safety profile of I.V. golimumab remained consistent with previously reported week 24 data. Through week 24, adverse events (AEs) occurred in 53 percent of patients receiving I.V. golimumab and 49 percent of patients receiving placebo, and serious AEs were reported in more I.V. golimumab-treated patients (4 percent) than placebo-treated patients (2 percent). Rates of AEs and serious AEs at week 52 among patients receiving I.V. golimumab were 65 percent and 9 percent, respectively. There were no serious opportunistic infections through week 52 of the study. One case of tuberculosis and one death, a myocardial infarction secondary to community-acquired pneumonia, were reported in the I.V. golimumab group. Through week 52, the proportions of infusions and patients with infusion reactions were 0.7 percent and 3.6 percent, respectively, (versus 1.1 percent and 3.5 percent at week 24, respectively).


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