Comparative effectiveness and survival of infliximab,adalimumab, and etanercept for rheumatoid arthritis patients in the Hellenic Registry of Biologics: Low rates of remission and 5-year drug survival

Objective

To compare effectiveness, drug survival, and safety between infliximab, adalimumab, and etanercept, in a nationwide cohort of rheumatoid arthritis (RA) patients.

Methods

This study is a prospective cohort study of 1208 active RA patients. Effectiveness, drug survival, and serious adverse events during entire follow-up (median 2.9 years) were monitored.

Results

EULAR and CDAI responses were comparable between the three agents (EULAR good/moderate responses at 12 months ranged 76–79%). At 12 months, 15–23% achieved remission. For adalimumab and etanercept, adjusted hazard rate (HR) for EULAR/ACR remission (reference: infliximab) was 2.7 and 2.1 (95% confidence interval was 1.7–4.1 and 1.3–3.4, respectively); males (HR 1.6; 1.1–2.4), use of glucocorticoids (HR 2.0; 1.3–3.0), and swollen joint count >7 (HR 0.36; 0.24–0.55) were independent predictors. Five-year drug survival was 31%, 43%, and 49% for infliximab, adalimumab, and etanercept, respectively (p = 0.010). Infliximab was associated with significantly more withdrawals due to adverse events. Disease activity, CRP, and use of glucocorticoids predicted efficacy-related drug survival; age, use of methotrexate, and prior DMARDs failures predicted safety-related survival. Risk for serious infections was lower with adalimumab (odds ratio [OR] 0.62; 0.38–1.00) or etanercept (OR 0.39; 0.21–0.72) than infliximab, independent of the effects of age (OR 1.65; 1.37–2.00 per 10 years), tender joint count >10 (OR 1.86; 1.21–2.86), and glucocorticoids >35 mg/week (OR 1.83; 1.12–2.99).

Conclusions

Response rates were comparable among anti-TNF agents. Overall, 5-year drug survival was below 50%, with infliximab demonstrating increased safety-related discontinuations. Remission rates are low in clinical practice. Strategies to increase effectiveness and long-term survival of anti-TNF agents in RA are needed.     

One-Month Serotonin Infusion Results in a Prolonged Fall in Blood Pressure in the Deoxycorticosterone Acetate (DOCA) Salt Hypertensive Rat

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Psychosocial impact of obstetric fistula in women presenting for surgical care in Tanzania

Introduction and hypothesis

World Health Organisation data suggest that two million women live with the physical and psychosocial effects of obstetric fistula. As part of an expanded fistula programme in Tanzania, Comprehensive Community Based Rehabilitation in Tanzania (CCBRT) introduced an evaluation strategy to include impact of surgery on psychosocial aspects of obstetric fistula. This is an initial report documenting morbidity on admission.

Methods

A questionnaire assessing the impact of obstetric fistula was developed taking into account literature in the field including sections on: patient contact information, transport costs and a set of statements regarding the effects of fistula. The effects were spread across five domains: the physical consequences of obstetric fistula, the effects of a difficult delivery and possible stillbirth, the experience of isolation, the inability to undertake daily living activities and feelings of depression. The questionnaire was administered in Kiswahili by Tanzanian counsellors shortly after admission of patients onto the fistula ward.

Results

A total of 100 fistula patients reported high rates of physical and psychosocial morbidity. Over half of the patients said they would not have been able to access treatment without the transport costs being covered.

Conclusions

Fistula patients are affected by extremely high rates of physical and psychosocial morbidity. Further work is required to confirm these findings, validate assessment tools and assess contributing factors in greater detail over time, such as the effect of stillbirth, as well as the impact of surgery.     

Tumor diameter accurately predicts perioperative outcomes in T1 renal cancer treated with robot-assisted partial nephrectomy

Purpose

To compare diameter as a continuous variable with categorical R.E.N.A.L. nephrometry score (RNS) in predicting surgical outcomes of robotic partial nephrectomy (RPN).

Methods

We retrospectively reviewed consecutive patients receiving RPN at our institution between July 2007 and June 2014 (n = 286). Three separate multivariate analyses were performed to assess the relationship between RNS components (R = radius, E = endophyticity, N = nearness to collecting system, L = location relative to polar lines), total RNS, and diameter as a continuous variable with operating time, warm ischemia time (WIT), and estimated blood loss (EBL). Each linear regression model’s quality of fit to the data was assessed with coefficients of determination (R ²).

Results

Continuous tumor diameter and total RNS were each significantly correlated to operative time, EBL, and WIT (p < 0.001). Categorical R related to operative time (R = 2 vs. R = 1, p = 0.001; R = 3 vs. R = 1, p = 0.001) and WIT (R = 2 vs. R = 1, p = 0.003; R = 3 vs. R = 1, p = 0.016), but not to EBL. For each of these outcomes, diameter outperformed both R and total RNS, as assessed by R ². Age, body mass index, Charlson Comorbidity Index, and anterior versus posterior location did not correlate with surgical outcomes.

Conclusions

In this series of RPN from a high-volume center, surgical outcomes more closely related to tumor diameter than RNS. While RNS provides surgeons a standardized tool for preoperative planning of renal masses, tumor size may be employed as a more familiar measurement when counseling patients on potential outcomes.

     

Fetal loss following second trimester amniocentesis. Who is at greater risk? How to counsel pregnant women?

Objective: The purpose of this retrospective observational cohort study was to determine the impact of certain risk factors on fetal loss, after mid-trimester amniocentesis.

Material and methods: Six thousand seven-hundred and fifty-two (6752) consecutive amniocenteses with known pregnancy outcome performed during a 7-year period (2004–2010) were included in this study. Different maternal-, fetal- and procedure-related factors were evaluated in this study.

Results: During this 7-year period, 6752 cases who underwent amniocentesis, with complete data available were evaluated for the outcome and risk factors mentioned. Total fetal loss rate (FLR) up to the 24th week was 1.19%. Risk factors associated with increased risk of fetal loss after amniocentesis were maternal age (OR:2.0), vaginal spotting (OR:2.2) and serious bleeding (OR:3.5) during pregnancy, history of 2nd trimester termination of pregnancy (OR:4.0), history of more than three spontaneous (OR:3.0) or surgical first trimester abortions (OR:2.1), fibromas (OR:3.0) and stained amniotic fluid (OR:6.1).

Conclusions: Amniocentesis is a safe-invasive procedure for prenatal diagnosis with total FLR of 1.19% in our institution during the study period. The present study has emphasized the significance of certain risk factors for adverse outcome and therefore the need to individualize the risk.