Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed

in Annals of the Rheumatic Diseases (2004), 63(5), 508-516

Objective: To evaluate the efficacy and safety of monotherapy with adalimumab in patients with RA for whom previous DMARD treatment has failed. Methods: In a 26 week, double blind, placebo controlled ... [more ▼]

Objective: To evaluate the efficacy and safety of monotherapy with adalimumab in patients with RA for whom previous DMARD treatment has failed. Methods: In a 26 week, double blind, placebo controlled, phase III trial, 544 patients with RA were randomised to monotherapy with adalimumab 20 mg every other week, 20 mg weekly, 40 mg every other week, 40 mg weekly, or placebo. The primary efficacy end point was greater than or equal to 20% improvement in the ACR core criteria (ACR20 response). Secondary efficacy end points included ACR50, ACR70, EULAR responses, and the Disability Index of the Health Assessment Questionnaire (HAQ DI). Results: After 26 weeks, patients treated with adalimumab 20 mg every other week, 20 mg weekly, 40 mg every other week, and 40 mg weekly had significantly better response rates than those treated with placebo: ACR20 (35.8%, 39.3%, 46.0%, 53.4%, respectively v 19.1%; pless than or equal to 0.01); ACR50 (18.9%, 20.5%, 22.1%, 35.0% v 8.2%; pless than or equal to 0.05); ACR70 (8.5%, 9.8%, 12.4%, 18.4% v 1.8%; pless than or equal to 0.05). Moderate EULAR response rates were significantly greater with adalimumab than with placebo (41.5%, 48.2%, 55.8%, 63.1% v 26.4%; pless than or equal to 0.05). Patients treated with adalimumab achieved better improvements in mean HAQ DI than those receiving placebo (-0.29, -0.39, -0.38, -0.49 v -0.07; pless than or equal to 0.01). No significant differences were found between adalimumab and placebo treated patients for serious adverse events, serious infections, or malignancies. Injection site reaction occurred in 10.6% and 0.9% of adalimumab and placebo treated patients, respectively (pless than or equal to 0.05). Conclusion: Among patients with RA for whom previous DMARD treatment had failed, adalimumab monotherapy achieved significant, rapid, and sustained improvements in disease activity and improved physical function and was safe and well tolerated. [less ▲]

Oral monthly ibandronate: rationale and clinical potential in postmenopausal osteoporosis

in Annals of the Rheumatic Diseases (2003, June)

Radiographic severity of knee osteoarthritis is highly correlated with future progression of the disease

in Annals of the Rheumatic Diseases (2002, June), 61(Suppl.1), 124

Glucosamine sulfate slows-down osteoarthritis progression in postmenopausal women: pooled analysis of two large, independent, randomised, placebo-controlled, double-blind, prospective 3-year trials

in Annals of the Rheumatic Diseases (2002, June), 61(Suppl.1),

Joint space narrowing is poorly correlated with symptoms worsening in knee-osteoarthritis: results from the prospective follow-up of 106, placebo-treated patients for three years

in Annals of the Rheumatic Diseases (2002, June), 61(Suppl.1), 121

Correlation between mean and minimum joint space measurements in a long-term trial with glucosamine sulfate, an osteoarthritis modifying agent

in Annals of the Rheumatic Diseases (2002, June), 61(Suppl.1),

Increased matrix metalloproteinase-3 serum levels in rheumatic diseases: relationship with synovitis and steroid treatment

in Annals of the Rheumatic Diseases (2002), 61(2), 161-166

OBJECTIVE: To determine matrix metalloproteinase-3 (MMP-3) serum levels in patients with rheumatic diseases and to study the relation between MMP-3 and C reactive protein (CRP) levels. METHODS: MMP-3 ... [more ▼]

OBJECTIVE: To determine matrix metalloproteinase-3 (MMP-3) serum levels in patients with rheumatic diseases and to study the relation between MMP-3 and C reactive protein (CRP) levels. METHODS: MMP-3 serum levels were determined by enzyme linked immunosorbent assay (ELISA) in (a) patients with active inflammatory rheumatic diseases: rheumatoid arthritis (RA), psoriatic arthritis, polymyalgia rheumatica, acute crystal arthritis, and ankylosing spondylitis; (b) patients with active inflammatory systemic diseases: cutaneo-articular or renal systemic lupus erythematosus (SLE), systemic sclerosis, and vasculitides; (c) patients with non-inflammatory rheumatic diseases: osteoarthritis and fibromyalgia; (d) critically ill patients without rheumatic diseases, representing an acute inflammatory control group; (e) healthy controls. RESULTS: MMP-3 serum levels were significantly increased in patients with active RA, psoriatic arthritis, and polymyalgia rheumatica, whether treated or not by corticosteroids, and in female patients with acute crystal arthritis. MMP-3 serum levels were normal in steroid-free patients with active cutaneo-articular or renal SLE, systemic sclerosis, and vasculitides but were significantly increased in steroid treated patients. MMP-3 levels were normal in fibromyalgia, osteoarthritis, ankylosing spondylitis, and acute inflammatory controls. MMP-3 was significantly correlated with CRP in RA (r=0.5, p=0.0004) but not in any of the other disease groups. CONCLUSIONS: MMP-3 serum levels are increased in inflammatory rheumatic diseases characterised by joint synovitis, such as RA, polymyalgia rheumatica, psoriatic arthritis, and acute crystal arthritis-that is, whether the diseases are acute or chronic, erosive or not. They are normal in SLE, systemic sclerosis, and vasculitides as well as in non-rheumatic inflammatory controls, but are significantly increased by steroids. These data strongly suggest that serum MMP-3 reflects synovial inflammation. [less ▲]

Long-term Effects of Nonsteroidal Antiinflammatory Drugs on Human Chondrocytes in Alginate Beads

in Annals of the Rheumatic Diseases (2001), 60(suppl1), 284

Intensive and prolonged health promotion strategy may increase self-reported osteoporosis prevalence among postmenopausal women

in Annals of the Rheumatic Diseases (2000), 59(S1), 58

Health-related quality of life scores and future use of health care resources in patients with rheumatoid arthritis and osteoarthritis : implication for health services research in arthritis

in Annals of the Rheumatic Diseases (2000), 59(S1), 277