This trial is too small to draw definitive conclusions, but it provides evidence that using infliximab as maintenance therapy in patients in glucocorticoid-induced remission of newly diagnosed giant cell arteritis is of no benefit and may be harmful. If infliximab has benefit, it is unlikely to be great. ClinicalTrials.gov registration number: NCT00076726.

Objective. To assess the safety and efficacy of golimumab in methotrexate (MTX)-naive patients with active rheumatoid arthritis (RA).Methods. MTX-naive patients with RA (n ‫؍‬ 637) were randomized to receive placebo plus MTX (group 1), golimumab 100 mg plus placebo (group 2), golimumab 50 mg plus MTX (group 3), or golimumab 100 mg plus MTX (group 4). Subcutaneous injections of golimumab or placebo were administered every 4 weeks. The dosage of MTX/placebo capsules started at 10 mg/week and escalated to 20 mg/week. The primary end point, the proportion of patients meeting the American College of Rheumatology 50% improvement criteria

For patients with refractory schizophrenia and high levels of hospital use, clozapine was somewhat more effective than haloperidol and had fewer side effects and similar overall costs.

Objective. Golimumab, administered subcutaneously every 4 weeks, has been shown to be effective in reducing the signs and symptoms of active psoriatic arthritis (PsA) through week 24 of the GO-REVEAL study. Herein we report 1-year clinical, radiographic, and safety findings.Methods. Adult patients with active PsA (>3 swollen and >3 tender joints) were randomly assigned to receive subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks through week 20. At week 16, patients with <10% improvement from baseline in swollen and tender joint counts entered a blinded early escape phase, with placebo crossover to golimumab 50 mg, golimumab 50 mg increased to 100 mg, and golimumab 100 mg continued at 100 mg. Patients receiving placebo who did not enter the early escape phase crossed over to golimumab 50 mg at week 24. Findings through 1 year are reported, including the secClinicalTrials.gov identifier: NCT00265096.

Objective. To evaluate the effect of infliximab on progression of structural damage over 2 years in patients with ankylosing spondylitis (AS).Methods. In the Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy (ASSERT), a randomized, double-blind, placebocontrolled trial of the efficacy of infliximab compared with placebo, 279 patients with active AS received either placebo through week 24 and then infliximab 5 mg/kg from week 24 through week 96 (n ‫؍‬ 78) or infliximab 5 mg/kg from baseline through week 96, administered every 6 weeks after a loading dose (n ‫؍‬ 201; these patients were the focus of the radiographic analyses). Radiographic findings in patients from the ASSERT trial were indistinguishable from those in a historical control cohort of patients who had no prior use of anti-tumor necrosis factor agents (from the Outcome in Ankylosing Spondylitis International Study [OASIS] database; n ‫؍‬ 192). Radiographic progression of structural damage from baseline to the 2-year followup was scored using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). All images were scored in one batch.Results. Median changes in the mSASSS from baseline to year 2 were 0.0 for both the OASIS and the ASSERT cohorts (P ‫؍‬ 0.541). Mean changes in the mSASSS were also similar between the OASIS and ASSERT cohorts (mean ؎ SD change over 2 years 1.0 ؎ 3.2 and 0.9 ؎ 2.6, respectively). In addition, results from sensitivity analyses did not show a statistically significant difference in the mSASSS between the OASIS and ASSERT cohorts.Conclusion. AS patients who received infliximab from baseline through week 96 did not show a statistically significant difference in inhibition of structural damage progression at year 2, as assessed using the mSASSS scoring system, when compared with radiographic data from the historical control OASIS cohort. Improvements in clinical outcomes and spinal inflammation have been previously demonstrated with the use of infliximab therapy.