FDA Approves Humira for Psoriatic Arthritis
by Yael Waknine, Medscape News
Adalimumab (Humira) Approved for Psoriatic Arthritis and Early RA On Oct. 3, the FDA approved a new indication and expanded the rheumatoid arthritis (RA) indication for adalimumab subcutaneous injection (Humira, made by Abbott Laboratories, Inc.), allowing its use in the treatment of psoriatic arthritis, and as first-line treatment for severe, active, and progressive RA in methotrexate (MTX)-naive adults.Approval of the psoriatic arthritis indication was based on the results of two clinical studies, including the phase 3 placebo-controlled Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT) in 313 patients.Data from the ADEPT trial showed that nearly 60% of adalimumab-treated patients achieved a 20% improvement in arthritis signs and symptoms (American College of Rheumatology [ACR] 20) at week 12. The response was sustained through week 24, at which point nearly 25% of patients demonstrated a 70% improvement in ACR score (ACR 70). Adalimumab-treated patients also demonstrated significantly less bone erosion and joint-space narrowing at week 24 compared with placebo (increase in modified Total Sharp Score [mTSS] > 0.5 units: 9% vs 28.9%). Inhibition of disease progression was maintained through week 48 in patients continuing treatment during an open-label extension period.In addition, 42% of adalimumab-treated patients with more than 3% body surface involvement at baseline demonstrated a 90% improvement in Psoriasis Area and Severity Index score at 24 weeks compared with none of those receiving placebo. Approval of adalimumab as first-line therapy for RA was based on results from the PREMIER/early RA trial, showing that treatment with adalimumab plus MTX successfully inhibited radiographic progression in patients with recently diagnosed RA of fewer than three years' duration. In the trial, addition of adalimumab to MTX therapy yielded significant decreases in mTSS from baseline and nearly doubled remission rates at one and two years compared with use of MTX alone (mean, 1.3 vs 5.7 and 1.9 vs 10.4, respectively; Disease Activity Score <>
Adalimumab (Humira) Approved for Psoriatic Arthritis and Early RA On Oct. 3, the FDA approved a new indication and expanded the rheumatoid arthritis (RA) indication for adalimumab subcutaneous injection (Humira, made by Abbott Laboratories, Inc.), allowing its use in the treatment of psoriatic arthritis, and as first-line treatment for severe, active, and progressive RA in methotrexate (MTX)-naive adults.Approval of the psoriatic arthritis indication was based on the results of two clinical studies, including the phase 3 placebo-controlled Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT) in 313 patients.Data from the ADEPT trial showed that nearly 60% of adalimumab-treated patients achieved a 20% improvement in arthritis signs and symptoms (American College of Rheumatology [ACR] 20) at week 12. The response was sustained through week 24, at which point nearly 25% of patients demonstrated a 70% improvement in ACR score (ACR 70). Adalimumab-treated patients also demonstrated significantly less bone erosion and joint-space narrowing at week 24 compared with placebo (increase in modified Total Sharp Score [mTSS] > 0.5 units: 9% vs 28.9%). Inhibition of disease progression was maintained through week 48 in patients continuing treatment during an open-label extension period.In addition, 42% of adalimumab-treated patients with more than 3% body surface involvement at baseline demonstrated a 90% improvement in Psoriasis Area and Severity Index score at 24 weeks compared with none of those receiving placebo. Approval of adalimumab as first-line therapy for RA was based on results from the PREMIER/early RA trial, showing that treatment with adalimumab plus MTX successfully inhibited radiographic progression in patients with recently diagnosed RA of fewer than three years' duration. In the trial, addition of adalimumab to MTX therapy yielded significant decreases in mTSS from baseline and nearly doubled remission rates at one and two years compared with use of MTX alone (mean, 1.3 vs 5.7 and 1.9 vs 10.4, respectively; Disease Activity Score <>
posted by Ricardo Pocurull at 12:29 PM
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