Remission in rheumatoid arthritis patients treated with etanercept monotherapy: clinical practice and clinical trial experience.

OBJECTIVES: To assess, in a randomised controlled trial (RCT) and in clinical practice, an association of time to remission and baseline disease activity with both induction of remission and sustained remission in etanercept-treated patients with rheumatoid arthritis (RA). METHODS: Data from an RCT (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes [TEMPO]; n=682) and an observational registry (Rheumatoid Arthritis DMARD Intervention and Utilization Study [RADIUS II]; n=4341) were used to evaluate disease activity (Clinical Disease Activity Index [CDAI] score) over time in patients initiating etanercept (monotherapy or with methotrexate). CDAI remission (CDAI≤2.8) and sustained remission (≥6 months) were determined through year 3 by treatment group, study, time to remission, and disease severity. RESULTS: Patients from TEMPO and RADIUS II who received etanercept monotherapy showed similar CDAI remission rates (39% and 35%, respectively, at 3 years). Among patients who received etanercept with methotrexate, remission rates were 54% and 36%, respectively. Remission occurred more rapidly in TEMPO than RADIUS II perhaps from differences in compliance, patient populations, or sequence of combination therapy initiation. Generally, more patients with lower baseline CDAI scores achieved remission than those with higher scores. Continued remission appeared more likely in patients achieving remission earlier in the course of their therapy (0-6 months). CONCLUSIONS: Remission by year 3 in etanercept-treated (with and without methotrexate) patients with RA occurred in ≥35% of patients in both an RCT (TEMPO) and a clinical practice setting (RADIUS II), and more frequently in those with lower baseline disease severity. Patients with lower RA disease activity were more likely to reach remission. Continued remission may be more likely in patients who achieved remission earlier.

Minimally important difference of Health Assessment Questionnaire in psoriatic arthritis: relating thresholds of improvement in functional ability to patient-rated importance and satisfaction.

OBJECTIVE: To evaluate changes in function as measured by Health Assessment Questionnaire Disability Index (HAQ-DI) and the meaningfulness of the changes, in importance and satisfaction, in patients with psoriatic arthritis (PsA). METHODS: HAQ-DI was assessed at baseline and at Weeks 4, 12, and 24 in a randomized double-blind study of 205 patients with active PsA receiving etanercept 25 mg twice weekly or placebo. Concurrently, patients rated the importance of and satisfaction with their change in function on a 7-point scale (1 = not at all important/satisfied; 7 = extremely important/satisfied). Mean HAQ-DI improvement corresponding to ratings of minimally (2-3) or very (6-7) important or satisfied was determined using a posthoc linear mixed-model analysis. Patient importance ratings were used as an anchor to estimate minimally important difference (MID) for HAQ-DI; distribution-based estimates were also calculated. RESULTS: A total of 161 patients (69 placebo; 92 etanercept) had ≥ 1 HAQ-DI scores showing improvement from baseline and a corresponding importance or satisfaction rating. HAQ-DI improvements corresponding to importance scale ratings of 2 or 3 were 0.335 (95% CI 0.214, 0.455) and 0.360 (95% CI 0.263, 0.456), respectively, suggesting an MID of about 0.35. HAQ-DI improvements corresponding to satisfaction scale ratings of 2 and 3 were 0.293 (95% CI 0.230, 0.357) and 0.360 (95% CI 0.307, 0.413). For a given change in HAQ-DI, nearly two-thirds of patients indicated a lower rating for satisfaction than for importance. This trial was registered in the ClinicalTrials.gov registry (NCT00317499). CONCLUSION: Our study suggests the MID for HAQ-DI in PsA is about 0.35. The results may also provide insight into patient satisfaction with changes in function and expectations for therapy.

Cell recovery comparison between plasma depletion/reduction- and red cell reduction-processing of umbilical cord blood.

BACKGROUND AIMS: Limited cell dose has hampered the use of cord blood transplantation (CBT) in adults. One method of minimizing nucleated cell loss in cord blood (CB) processing is to deplete or reduce plasma but not red blood cells - plasma depletion/reduction (PDR). METHODS: The nucleated cell loss of PDR was studied, and determined to be less than 0.1% in the discarded supernatant plasma fraction in validation experiments. After testing and archival sampling, the median nucleated cell recovery for PDR processing was 90%, and median CD34(+) cell recovery 88%. In a CB bank inventory of 12 339 products with both pre- and post-processing total nucleated cells (TNC), PDR processing resulted in median post-processing TNC recoveries of 90.0% after testing and archival samples removal. Using the same 10 CB units divided into two halves, we compared directly the recovery of PDR against hydroxyethyl starch red cell reduction (RCR) for TNC, CD34(+) cells and colony-forming units (CFU-GM, CFU-E, CFU-GEMM and total CFU) after parallel processing. We also compared the loss of very small embryonic-like stem cells (VSEL). RESULTS: We demonstrated significantly higher recoveries using PDR for TNC (124%), CD34(+) cells (121%), CFU-GM (225%), CFU-GEMM (201%), total CFU (186%) and VSEL (187%). The proportion of high TNC products was compared between 10 912 PDR and 38 819 RCR CB products and found to be 200% higher for products that had TNC ≥150 × 10(7) (P = 0.0001) for the PDR inventory. CONCLUSIONS: Our data indicate that PDR processing of CB provides a significantly more efficient usage of this valuable and scarce resource.