Sustained discontinuation of infliximab with a raising-dose strategy after obtaining remission in patients with rheumatoid arthritis: the RRRR study, a randomised controlled trial.

OBJECTIVES: The aim of this study is to determine whether the 'programmed' infliximab (IFX) treatment strategy (for which the dose of IFX was adjusted based on the baseline serum tumour necrosis factor α (TNF-α)) is beneficial to induction of clinical remission after 54 weeks and sustained discontinuation of IFX for 1 year. METHODS: In this multicentre randomised trial, patients with IFX-naïve rheumatoid arthritis with inadequate response to methotrexate were randomised to two groups; patients in programmed treatment group received 3 mg/kg IFX until week 6 and after 14 weeks the dose of IFX was adjusted based on the baseline levels of serum TNF-α until week 54; patients in the standard treatment group received 3 mg/kg of IFX. Patients who achieved a simplified disease activity index (SDAI) ≤3.3 at week 54 discontinued IFX. The primary endpoint was the proportion of patients who sustained discontinuation of IFX at week 106. RESULTS: A total of 337 patients were randomised. At week 54, 39.4% (67/170) in the programmed group and 32.3% (54/167) in the standard group attained remission (SDAI ≤3.3). At week 106, the 1-year sustained discontinuation rate was not significantly different between two groups; the programmed group 23.5% (40/170) and the standard group 21.6% (36/167), respectively (2.2% difference, 95% CI -6.6% to 11.0%; p=0.631). Baseline SDAI <26.0 was a statistically significant predictor of the successfully sustained discontinuation of IFX at week 106. CONCLUSION: Programmed treatment strategy did not statistically increase the sustained remission rate after 1 year discontinuation of IFX treatment.

Attachment of artificial cartilage to underlying bone.

The key problem with artificial joint materials is obtaining quick and firm attachment onto the underlying bone. In developing artificial articular cartilage, composed of polyvinyl alcohol hydrogel (PVA-H), this problem was solved by using a composite osteo-chondral device (COD). This enables attachment within four weeks post-operation by massive bone ingrowth into the pores. The COD consists of PVA-H as an artificial cartilage and titanium fiber mesh (TFM) as porous artificial bone. In this study, the strength of the shear resistance force at the interface of the PVA-H and the TFM fabricated by injection molding and the changes in the mechanical properties of the PVA-H fabricated by high temperature during the injection-molding process were examined. The shear resistance force was strengthened markedly by using injection molding and no important deterioration of the PVA-H was found. Morphological examination of canine spines, to which artificial intervertebral discs made of the COD were implanted, showed good bonding of the COD with the vertebral bodies for an extended period of 30 months, and encouraged us to use the COD clinically.