Improvement in patient-reported outcomes after rituximab in rheumatoid arthritis patients: An open-label assessment of 175 patients.

OBJECTIVE: Patient-reported outcomes (PROs) reflect treatment efficacy from the patients' perspective. The objective was to assess PROs improvement with rituximab in rheumatoid arthritis. METHODS: Patients with long-standing rheumatoid arthritis received rituximab 1000mg twice at 2 weeks interval, and were assessed over 6 months. PROs including physical PROs (pain, functional assessment, physical quality of life) and mental or mixed aspects (fatigue, sleep and mental quality of life) were assessed. Standardized response means were calculated. Early improvement in PROs was used to predict EULAR response at 6 months. RESULTS: For the 175 patients (mean age 54.6±10.6 years, mean disease duration 12.9±9.3 years), the plateau of efficacy of rituximab on PROs was reached at week 12, and the effect was more prominent on physical PROs (e.g., pain standardized response means -0.75 [95% confidence interval -0.91; -0.60]), than on sleep (-0.43; [-0.56; -0.29]). It was not possible to accurately predict 6-month EULAR response by early improvement in PROs. CONCLUSION: Rituximab was effective on PROs with an early effect. PROs reflecting physical aspects were more modulated by this biologic than other PROs (fatigue, sleep or mental quality of life). Links between sleep difficulties, fatigue and RA should be further studied.

A 3 mg/kg starting dose of infliximab in active spondyloarthritis resistant to conventional treatments is efficient, safe and lowers costs.

OBJECTIVE: We assessed the efficacy, tolerance and cost of a 3 mg/kg starting dose of infliximab for ankylosing spondylitis (AS) and psoriatic arthritis (PsA). METHODS: We retrospectively followed-up 45 biologic-naive consecutive patients (11 with axial AS, 24 with axial and peripheral [mixed] AS and 10 with PsA) who were treated between 2002 and 2005 with a 3 mg/kg dose of infliximab after failure of conventional therapies. The following variables were recorded: visual analog scale (VAS) scores of patient's global (G) and pain (P) assessment, duration of early morning stiffness (EMS), disease activity (BASDAI) and functional disability (BASFI). Treatment responses were assessed at 6 and 12 months using the AS assessment score (ASAS)-20% and -40% criteria and BASDAI-50. RESULTS: Baseline characteristics of the 29 men and 16 women were (median [range]): G-VAS, 70 [13-100]; P-VAS, 70 [13-100]; EMS, 60 [0-180] minutes; BASDAI, 64.4 [23.9-100]; BASFI, 57.2 [3.5-98.5]. All manifestations regressed significantly (p<0.0001) for 39 (86.7%) and 24 (53.5%) patients at 6 and 12 months, respectively; 26 (57.8%) had achieved ASAS-20 responses at 6 months that persisted at 1 year for 20 (44.4%); 19 (42.2%) and 12 (26.7%) satisfied BASDAI 50 criteria at 6 and 12 months, respectively. Interestingly, almost 30% still received low-dose infliximab after 4 years of follow-up. CONCLUSION: An initial dose of 3 mg/kg of infliximab significantly attenuated AS and PsA manifestations in>40% of the patients, making use of this dose highly advantageous in terms of safety and 33% lower cost.

Choice of second-line disease-modifying antirheumatic drugs after failure of methotrexate therapy for rheumatoid arthritis: a decision tree for clinical practice based on rheumatologists' preferences.

OBJECTIVE: To survey rheumatologists' preferences for the choice of a second-line disease-modifying antirheumatic drug (DMARD) after inadequate response with methotrexate (MTX) therapy in rheumatoid arthritis (RA). METHODS: Thirty-six rheumatologists stated their preferences for RA treatment after inadequate response with MTX therapy (optimal dose at least 6 months). From the initial scenario, we derived 54 vignettes varying by rheumatoid factor or anti-cyclic citrullinated peptide antibody presence, swollen joint count, Disease Activity Score in 28 joints, and structural damage. Respondents stated their preference among 5 therapeutic options: MTX continuation, switch to another conventional DMARD, addition of another conventional DMARD, addition of anakinra, or addition of a tumor necrosis factor (TNF) blocker. Presentation by pairs yielded 10 combinations of strategies for each variant, totaling 540 vignettes; participants evaluated a random sample of 180 vignettes. Determinants of each top-ranked option were analyzed by logistic regression. The compilation of these data served to define a therapeutic algorithm. RESULTS: The responses of 33 rheumatologists were analyzable. Therapeutic preferences corresponded to the top-ranked options. For patients with mild or moderately active RA, either a switch or step-up strategy to another conventional DMARD was top ranked. TNF blockers were preferred for RA patients with high disease activity or progressive structural damage. On the basis of these preferences, we developed a simple decision tree for use in daily clinical practice. CONCLUSION: Our simple, easy-to-use decision tree developed from rheumatologists' preferences for therapy after failure of MTX therapy in RA treatment may guide rheumatologists in daily practice to choose a second-line DMARD.