BACKGROUND: Differential withdrawal of patients from clinical trials (dropout) complicates interpretation of the effect of intervention on the exacerbation frequency in COPD studies. We examined the impact of differential dropout on exacerbations in moderate-to-very severe COPD (GOLD grades 2–4). METHODS: Patients in 3 pooled COPD studies 1,2,3 were randomised to budesonide/formoterol (B/F 320/9µg bid) or placebo (P) via Turbuhaler®. Exacerbations, dropouts and a composite of the two outcomes were examined over the first 3 months of treatment. RESULTS: 1583 COPD patients were studied (24% moderate; 61% severe, 14% very severe). B/F improved time to first exacerbation in moderate and severe but not very severe COPD (HR B/F / P : 0.43 [95% CI 0.25–0.72], 0.45 [0.33–0.63] and 0.58 [0.32–1.05]) vs. P. Time to dropout was improved by B/F vs. P, the differences being larger with increasing COPD severity (HR B/F / P : 0.62 [0.34–1.11], 0.56 [0.39–0.81] and 0.38 [0.18–0.80]). A composite measure of time to first exacerbation or dropout showed a significant effect of B/F in all severities. CONCLUSIONS: Differential study dropout (greater with P than B/F) increased as the severity of COPD worsened. This should be considered when interpreting clinical COPD trial data. 1.Calverley et al. ERJ 2003;22:912–9 2.Szafranski et al. ERJ 2003;21:74–81 3.Welte et al. AJRCCM 2009;180:741–50.

Background: The aim of this study was to develop a shortened Crohn's Disease Activity Index (CDAI). Methods: A short CDAI was developed retrospectively using patient‐level data from four budesonide clinical trials to select variables from the full CDAI which best predicted health‐related quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ), using the multiple linear regression model. The validity, reliability, and responsiveness of the short CDAI compared to the original CDAI were determined using data from nine clinical trials of budesonide. Results: The variables selected for the short CDAI were abdominal pain, diarrhea frequency, and general well‐being. In all nine studies involving 1373 patients with active and inactive CD (5863 visits), the Pearson correlation coefficients between the short CDAI scores and the original CDAI scores at baseline (r = 0.899, P < 0.001), and the score differences (r = 0.963, P < 0.001) were excellent. The short CDAI accounted for 82.4% of the variance of the original CDAI. The intraclass correlation coefficient for the short CDAI was marginally better than that for the full CDAI, and both demonstrated good reliability (r = 0.600 versus r = 0.549). In patients with active CD who remitted during follow‐up, the mean short CDAI scores decreased from 247 to 97, a score difference of 150 ± 60 points (P < 0.001). In patients with stable CD who relapsed, the mean short CDAI scores increased from 109 to 244 points, a score difference of 135 ± 62 points (P < 0.001). Conclusions: The short CDAI is a valid, reliable, and responsive tool for the measurement of CD activity. (Inflamm Bowel Dis 2011;)

Methods: A short CDAI was developed retrospectively using patient-level data from four budesonide clinical trials to select variables from the full CDAI which best predicted health-related quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ), using the multiple linear regression model. The validity, reliability, and responsiveness of the short CDAI compared to the original CDAI were determined using data from nine clinical trials of budesonide.

p = 0.30) and 2.0 mg/kg-36.9%(placebo vs. 2.0 mg/kg p = 0.04) whereas the corresponding response rates were 41.4%, 49.2% (placebo vs. 0.5mg/kg p=0.36), and 53.1% (placebo vs. 2.0 mg/kg p=0.14)Pharmacokinetic data indicated the antibody had a half-life of approximately 12 days.Pharmacodynamic data suggested that complete saturation of ct4137 was not achieved over the duration of treatment.Subgroup analysis showed that patients who obtained consistent and sustained saturation of a4J37 on PBLs were more likely to enter remission than those who did not.No important differences in adverse events were noted among the three treatment groups.Conclusion MLN-02, administered at 2.0 mg/kg, is a biologically active therapy for the treatment of active CD.Future trials to evaluate higher doses of MLN02 and the relation of higher doses to sustained saturation are under consideration.