The efficacy of 4 g 5-aminosalicylic acid (5-ASA, mesalamine) enemas was assessed in 666 patients with distal ulcerative colitis. Patients were enrolled in an open-label compassionate use program. One 4 g 5-ASA enema was administered each night for a period of four weeks and the disease activiry index was assessed at baseline and on days 14 and 28. On days 14 and 28, 78.0% and 88.1 % of patients, respectively, demonstrated an improvement in disease activiry index. The mean decline in disease activiry index on day 14 was 40. 7% (P=0.0001) and on day 28 it was 55.4% (P=0.0001). Efficacy was similar whether the disease was confined to or extended beyond 30 cm from the anus. There was no difference in efficacy in patients suffering their first episode of disease compared to patients suffering subsequent attacks.
and steroid treatment, ESR &/or CRP; current non-RA drugs, and co-morbidities. R2 values ranged from 0.277 (no inflammatory marker) to 0.331 (with CRP), while mean HAQ prediction error was 0.13 (0.27). Step 2&hibar;Costs were assessed in 8,423 GPRD cases with similar gender balance (69.8% female) but older mean 64 years). Predicted HAQ (pHAQ) scores ranged from 0.45 to 3.00, with a mean of 1.78 (0.31). Mean annual cost of care in this population was £2792 (£5633), with 46% from hospital admissions, 24% prescriptions, 20% GP consultations, 11% outpatient attendances, and 11% investigations. Step 3&hibar;Total costs (pCOST) were optimally predicted from EXP^(5.613ϩ(Age*0.005)ϩ (pHAQ*1.185)ϩ (Age*pHAQ*-0.001)). pCOST has an exponential correlation to pHAQ (R2ϭ0.986; EXP^(342ϩ(pHAQ*1.188)). CONCLUSIONS: Age-adjusted predicted total health care costs for RA patients increased exponentially across the range of estimated disability. Although higher than published estimates, exclusion of support-service costs suggests these values may be conservative.
OBJECTIVES: Biologic treatments for rheumatoid arthritis (RA) vary widely in both the time required to administer treatment and treatment frequency. The primary aim of this study is to quantify the tradeoffs RA patients are willing to make between treatment time and frequency. METHODS: Patients with a self-reported physician diagnosis of moderate-to-severe RA completed a Web-enabled conjointanalysis survey. Severity of self-reported symptoms was determined by the Routine Assessment of Patient Index Data 3 (RAPID3) score. Patients were presented with a series of treatment-choice questions. Each hypothetical treatment included six attributes: response rate, mode of administration, treatment time, treatment frequency, and the risks of immediate, mild and serious treatment reactions. Preference weights were estimated using mixed-logit and were used to calculate the relative importance of treatment attributes and the marginal rate of substitution between treatment time and frequency (MRS). RESULTS: A total of 901 patients completed the survey. The risk of serious treatment reaction was the most important attribute followed by the frequency of treatments and treatment response rate, which were equally important. The risk of a mild treatment reaction was the least important attribute. The MRS implies that if the duration of a 4-hour infusion administered 4 times per year were reduced to 2 hours: 1) the frequency would have to be 10.4 times per year to keep utility constant; 2) the frequency of a 4 hour infusion administered 4 times per year would have to be reduced to 1.6 times per year to generate an equivalent change in utility; and 3) there would be a 50% increase in predicted probability of choosing the treatment if all other attributes of this and other RA treatments were unchanged. CONCLUSIONS: Convenience of RA treatment is important to RA patients. Treatment duration and frequency likely play an important role in patients' choice of RA treatment.OBJECTIVES: Quantify the relative difference in improvement in patient-reported outcomes between rheumatoid arthritis (RA) patients achieving different T2T-related goals versus those who do not. METHODS: This is a post hoc analysis of the RESTART trial, an active switch study, where patients were treated with IFX for 22 weeks and clinicians allowed to dose escalate at fixed intervals to achieve a EULAR response. In this analysis, multiple analytical sub-groups were defined using realworld CDAI thresholds. Given high baseline Clinical Disease Activity Index (CDAI) scores, sub-group definitions included goals of low or moderate disease activity, with or without significant improvement in CDAI. Sub-group response thresholds at Week 26 included real-world specific cut points of: CDAIՅ19.6 (Sub-group A); CDAIՅ19.6 AND CDAI reduction of at least 10 points (Sub-group B); CDAIՅ7.6 (Subgroup C). Within each sub-group, responder versus non-responder cohorts were compared on HAQ scores and all domains of the SF-36. Descriptive statistics and a non-parametric Wilcoxon test were used...
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