Centocor reports positive data from two Phase III arthritis trials
JNJ | Quote | Chart | News | PowerRating -- Centocor Ortho Biotech, a subsidiary of Johnson & Johnson, has reported new long-term data from two pivotal, Phase III clinical trials which showed that patients with active rheumatoid arthritis or RA receiving Simponi every four weeks achieved sustained improvements in signs and symptoms and physical function response through one year.
Findings from the Go-After study demonstrated that patients with RA previously treated with adalimumab, etanercept or infliximab responded to, and maintained response to, Simponi through one year. At week 52, 63% of patients receiving Simponi 50mg achieved at least a 20% improvement in arthritis signs and symptoms as measured by American College of Rheumatology (ACR 20) response, and 41% achieved a 50% improvement in arthritis signs and symptoms as measured by ACR 50 response.
Simponi-treated patients who had discontinued previous anti-tumor necrosis factor (TNF) treatment for any reason sustained improvements in physical function, as measured by the health assessment questionnaire (HAQ), said Centocor Ortho Biotech.
At week 52, patients receiving Simponi 50 maintained a clinically relevant improvement from baseline. Similar results were previously reported at week 24. HAQ assesses the degree of difficulty a person has in accomplishing tasks in eight functional areas. The data also showed that 81% and 61% of patients receiving Simponi 50mg reported improvements from baseline in the number of tender and swollen joints, respectively.
Results from the Go-Forward study showed the efficacy of Simponi in patients with active RA despite prior treatment with methotrexate. At week 52, 64% of patients taking Simponi 50mg plus methotrexate achieved ACR 20 response, and 25% achieved a 70% improvement in arthritis signs and symptoms as measured by ACR 70 response.
There was no clear evidence of improved ACR response with the higher Simponi dose group (100mg). Importantly, investigators also reported that 48% of patients receiving Simponi 50mg plus methotrexate achieved a low level of disease activity as measured by disease activity score 28 (DAS 28) C-reactive protein (CRP) <2.6, which measures tender and swollen joints, inflammation and overall disease activity including measurement of serum CRP levels.
Mark Genovese, division co-chief of immunology and rheumatology at Stanford University and study investigator, said: "These data show that patients receiving golimumab, a once-monthly anti-TNF therapy, sustained clinical response through one year."
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