Rheumatoid arthritis patients initiating rituximab with low number of previous bDMARDs failures may effectively reduce rituximab dose and experience fewer serious adverse events than patients on full dose: a 5-year cohort study.

BACKGROUND: Rituximab is used for the treatment of active rheumatoid arthritis. In the present study, we examined the long-term flare risk and safety of reduced doses of rituximab. PATIENTS-METHODS: This was a prospective, observational, single-center study of patients starting rituximab on standard dose (SD). Patients were switched to low dose (LD) (1 g every 6 months), based on the treating rheumatologist's decision after having achieved sustained clinical responses, while the rest of the patients continued on standard dose (SD). During a 60-month period, we assessed (Kaplan-Meier survival analysis) the relapse rate (increase ≥ 1.2 in DAS28-ESR for ≥ 6 months) and discontinuations due to treatment failure in the low dose group, and we compared the incidence of serious adverse events (SAEs) between LD and SD groups. RESULTS: Out of 361 patients [females 83.4%, mean age 61.9 (10.6) years, seropositive 50.3%, median total comorbidities count 4], 81 patients (22.4%) entered LD in a median time of 24 months (95% CI 18-30 months). Seropositivity (OR 1.823), more than 2 previous bDMARDs failures (OR 0.428), and DAS28 < 4.88 at 6 months (OR 2.329) predicted the odds of entering LD (p < 0.05 for all). During 60 months of follow-up, only 7.5% of patients on LD relapsed. Patients on LD had significantly less SAEs and all-cause hospitalizations as compared to the SD group (p < 0.05 for all). Linear regression analysis showed that previous hospitalization while on bDMARDs (p < 0.0001), use of prednisolone > 5 mg/day while on rituximab (p < 0.0001), and a history of ≥ 2 previous csDMARDs (p = 0.041) predicted the risk of SAEs. CONCLUSION: In a cohort of patients with established RA and significant comorbidities who taper rituximab after substantial initial disease activity improvement, a low rate of relapses and lower risk of SAEs compared to SD were recorded. Seropositivity, a lower number of previous bDMARDs use, and lower DAS28 at 6 months predicted the probability of entering the LD regimen.

Quality of life before and after laparoscopic sleeve gastrectomy. A prospective cohort study.

BACKGROUND: There is a lack of adequate prospective data on quality-of-life (QOL) and its predictors in patients undergoing laparoscopic sleeve gastrectomy (LSG). The aim of this study was to assess longitudinal changes in QOL after LSG with the use of the obesity-specific Moorehead-Ardelt II questionnaire (MAII) and to identify clinical parameters associated with QOL outcome. METHODS: Morbidly obese patients consecutively admitted for LSG, over a 30-month period, were prospectively studied. QOL was assessed using the validated Greek version of the MAII questionnaire and a visual analogueue scale (VAS), preoperatively and at 6, 12, and 24 months postoperatively. Anthropometric data and obesity-related co-morbidities were recorded. RESULTS: A total of 111 patients with a mean age 36.8±9.2 years were included. Mean preoperative body mass index (BMI) was 49.1±7.5 kg/m2. Percentage excess BMI loss (%EBL) was 51.1±14.9, 64.2±17.9 and 66.4±18.0 at 6, 12, and 24 months, respectively. Postoperatively, all obesity-related co-morbidities were significantly improved. MAII score increased from -.40±1.30 preoperatively to 1.75±.83, 2.18±.80, and 1.95±.71 at 6, 12, and 24 months postoperatively (trend P<.001). Preoperative median (interquartile range) VAS was 3 (1) increasing to 9 (2), 10 (1), and 9 (1) at 6, 12, and 24 months postoperatively (P<.001). %EBL and reduction in obesity-related co-morbidities, especially resolution of diabetes and sleep apnea, correlated significantly with higher QOL during the course of the study. CONCLUSION: LSG, a safe and effective bariatric operation, results in sustained weight loss and significant improvements in QOL. Both weight loss and amelioration of co-morbidities contribute to higher level of postsurgical QOL.

Validation of the Greek translation of the obesity-specific Moorehead-Ardelt Quality-of-Life Questionnaire II.

Morbid obesity adversely affects quality of life. The assessment of health-related quality of life (HRQoL) needs specific measuring instruments. The Moorehead-Ardelt Quality-of-Life Questionnaire II (MA II) is an obesity-specific instrument widely used in bariatric surgery. The objective of this study was to translate and validate the MA II in Greek language. The study included the translation of the MA II followed by cross-validation with the Greek version of 36-item Short Form Health Survey (SF-36) and a Visual Analogue Scale (VAS) in subjects visiting an obesity clinic. Internal consistency was indicated by Cronbach's alpha coefficient and test-retest reliability by intraclass correlation coefficient (ICC). Construct validity was studied using Pearson's correlations between the MA II, the SF-36 and the VAS. A total of 175 patients were enrolled in the study. Test-retest analysis was applied to 40 patients with a 15-day interval. A very good internal consistency with Cronbach's alpha coefficient of 0.85 was shown. Excellent test-retest reliability was observed with an overall ICC of 0.981. Significant correlations between the Greek MA II and the other instruments as well as of each item of the MA II with the scores of SF-36 and the VAS indicated high construct and convergent validity. A negative correlation between the translated MA II total score and BMI confirmed high clinical validity. The Greek version of the MA II questionnaire has been generated and shown to be valid and reliable in measuring HRQoL in morbidly obese patients before and after bariatric surgery.