Induction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial.

BACKGROUND: In the present study, we explored the effects of immediate induction therapy with the anti-tumour necrosis factor (TNF)α antibody infliximab (IFX) plus methotrexate (MTX) compared with MTX alone and with placebo (PL) in patients with very early inflammatory arthritis. METHODS: In an investigator-initiated, double-blind, randomised, placebo-controlled, multi-centre trial (ISRCTN21272423, http://www.isrctn.com/ISRCTN21272423 ), patients with synovitis of 12 weeks duration in at least two joints underwent 1 year of treatment with IFX in combination with MTX, MTX monotherapy, or PL randomised in a 2:2:1 ratio. The primary endpoint was clinical remission after 1 year (sustained for at least two consecutive visits 8 weeks apart) with remission defined as no swollen joints, 0-2 tender joints, and an acute-phase reactant within the normal range. RESULTS: Ninety patients participated in the present study. At week 54 (primary endpoint), 32% of the patients in the IFX + MTX group achieved sustained remission compared with 14% on MTX alone and 0% on PL. This difference (p < 0.05 over all three groups) was statistically significant for IFX + MTX vs PL (p < 0.05), but not for IFX + MTX vs MTX (p = 0.10), nor for MTX vs PL (p = 0.31). Remission was maintained during the second year on no therapy in 75% of the IFX + MTX patients compared with 20% of the MTX-only patients. CONCLUSIONS: These results indicate that patients with early arthritis can benefit from induction therapy with anti-TNF plus MTX compared with MTX alone, suggesting that intensive treatment can alter the disease evolution. TRIAL REGISTRATION: The trial was registered at http://www.isrctn.com/ISRCTN21272423 on 4 October 2007 (date applied)/12 December 2007 (date assigned). The first patient was included on 24 October 2007.

Ankylosing spondylitis, psoriatic arthritis, and reactive arthritis show increased bone resorption, but differ with regard to bone formation.

OBJECTIVE: To test if markers of bone metabolism are altered in patients with seronegative spondyloarthropathies (SSpA). METHODS: We studied biochemical markers of bone resorption and bone formation, osteoprotegerin (OPG), and bone mineral density (BMD) in patients with psoriatic arthritis (PsA), ankylosing spondylitis (AS), and reactive arthritis (ReA) and healthy volunteers. RESULTS: The bone resorption markers urinary deoxypyridinoline and crosslinked telopeptide of collagen-I were significantly increased in patients with AS, PsA, and ReA; in PsA they correlated with the acute phase response (C-reactive protein and erythrocyte sedimentation rate). The bone formation markers were divergent: bone-specific alkaline phosphatase was increased in PsA, but not in AS or ReA. Osteocalcin levels were only elevated in AS. Serum levels of OPG were significantly increased in both AS and PsA. Dual energy x-ray absorptiometry (DEXA) measurements of lumbar spine and femoral neck revealed osteopenia in patients with AS, whereas the DEXA distribution was within normal range in PsA. CONCLUSION: Our data indicate high and, particularly in AS, unbalanced bone turnover in SSpA, consistent with the decrease in BMD found in patients with AS.

Joint protection and home hand exercises improve hand function in patients with hand osteoarthritis: a randomized controlled trial.

OBJECTIVE: To determine the effect of joint protection and home exercises on hand function of patients with hand osteoarthritis (OA). METHODS: Randomized, controlled, 3-month trial with a blinded assessor. Primary outcome parameter was grip strength; secondary parameters were Health Assessment Questionnaire and visual analog scales (VAS) for pain and global hand function. Forty patients with hand OA were randomly assigned to 2 groups: One group received instruction for joint protection and home hand exercises (JPE group), the control group received an information session about hand OA. RESULTS: Grip strength improved by 25% in the JPE group (right hand, P < 0.0001; left hand, P = 0.0005), but not in the control group. Global hand function (by VAS) improved in a larger proportion (65%) of patients in the JPE group (P < 0.05). CONCLUSIONS: Joint protection and hand home exercises, easily administered and readily acceptable interventions, were found to increase grip strength and global hand function.