Long-term safety and efficacy of eculizumab in generalized myasthenia gravis

Introduction: Eculizumab is effective and well tolerated in patients with antiacetylcholine receptor antibody-positive refractory generalized myasthenia gravis (gMG; REGAIN; NCT01997229). We report an interim analysis of an open-label extension of REGAIN, evaluating eculizumab's long-term safety and efficacy. Methods: Eculizumab (1,200 mg every 2 weeks for 22.7 months [median]) was administered to 117 patients. Results: The safety profile of eculizumab was consistent with REGAIN; no cases of meningococcal infection were reported during the interim analysis period. Myasthenia gravis exacerbation rate was reduced by 75% from the year before REGAIN (P < 0.0001). Improvements with eculizumab in activities of daily living, muscle strength, functional ability, and quality of life in REGAIN were maintained through 3 years; 56% of patients achieved minimal manifestations or pharmacological remission. Patients who had received placebo during REGAIN experienced rapid and sustained improvements during open-label eculizumab (P < 0.0001). Discussion: These findings provide evidence for the long-term safety and sustained efficacy of eculizumab for refractory gMG. Muscle Nerve 2019     

The effect of honey-coated bandages compared with silver-coated bandages on treatment of malignant wounds-a randomized study

Malignant wounds (MWs) occur in 5–10% of all cancer patients. Malodor and exudation are the most common side effects. The aim was to determine the influence of honey‐coated compared with silver‐coated bandages on treatment of MWs. Patients were randomly selected to enter either group A (honey‐coated bandages) or group B (silver‐coated bandages). Parameters were the following: wound size, cleanliness, malodor, exudation, and wound pain. Digital photographs, visual analog scales (VAS), and wound morphology registration were used for measurement at baseline and following the 4‐week intervention. Sixty‐nine patients with MWs and advanced cancer, aged 47–90 (median 65.6), were included. No statistically significant difference was noted between the groups with respect to wound size, degree of cleanliness, exudation, malodor, and wound pain. There was a median decrease in wound size of 15 cm² and 8 cm² in group A and B, respectively (p = 0.63). Based on post‐intervention pooled data from the groups, improvement was seen in 62% of the participants with respect to wound size and in 58% (n = 69) with respect to cleanliness. The VAS score for malodor (p = 0.007) and exudation (p < 0.0001) improved significantly post‐intervention. Patients with reduced wound size had a median survival time of 387 days compared with 134 days in patients with no wound reduction (p = 0.003). The use of honey‐coated and silver‐coated bandages improved the outcome of MWs. No differences were found between the two regimens. Both types of bandages are recommended for use by patients with MWs containing tumor debris and necrosis.     

Self‐efficacy in rheumatoid arthritis: translation and test of validity,reliability and sensitivity of the Danish version of the Rheumatoid Arthritis Self‐Efficacy Questionnaire (RASE)

Objectives: To describe the translation and test of the Danish version of the original British ‘Rheumatoid Arthritis Self‐Efficacy Questionnaire’ (RASE). Methods: The questionnaire was forward and back translated by individuals with Danish and English as their respective primary languages. The questionnaire was tested by five lay‐people and in the field by 10 + five persons with rheumatoid arthritis (RA). A test‐retest was performed on 62 outpatients with RA. The sensitivity of the adapted Danish version of RASE (RASE‐DK) was finally tested on 106 outpatients with RA – before, immediately after and three months after they had participated in a short self‐management course performed by a multidisciplinary team. Results: RASE‐DK showed good face validity, but ‘relaxation’ was interpreted in various ways. Internal consistency evaluated by Cronbach's alpha was 0.91. Reliability evaluated by the intra‐class correlation coefficient (ICC) was 0.88. A Bland–Altman plot showed good agreement. RASE‐DK, like the original English version of RASE, was not associated with disease activity (Disease Activity Score, DAS‐28) or disability (Health Assessment Questionnaire, HAQ), and correlated significantly with the Arthritis Self‐Efficacy Scale (ASES) subscales ‘other’ and ‘pain’, and total ASES. RASE‐DK showed a highly significant change, from baseline to immediately after participation in the short course (p < 0.001). The effect faded during the following three months. Conclusion: RASE‐DK met the appropriate standards for validity, reliability and sensitivity, and is appropriate for use in Denmark. However, the concept of self‐efficacy may be too abstract for a few individuals, and relaxation is interpreted in various ways by the Danish patients. Copyright © 2010 John Wiley & Sons, Ltd.     

Antibiotic exposure in early life and childhood overweight and obesity: A systematic review and meta‐analysis

We conducted a systematic review and meta‐analysis of observational studies investigating the association between antibiotic exposure in infancy and risk of childhood overweight and obesity. Thirteen studies, including a total of 527 504 children, were included in the systematic review and 8 were included in meta‐analyses. Exposure to antibiotics in infancy was associated with an increased odds ratio (OR) of childhood overweight and obesity (OR 1.11, 95% confidence interval [CI] 1.02‐1.20). Whereas exposure to 1 treatment only and exposure between 6 and 24 months were not associated with increased risk of childhood overweight and obesity, exposure to >1 treatment was associated with an OR of 1.24 (95% CI 1.09‐1.43) and exposure within the first 6 months of life was associated with an OR of 1.20 (95% CI 1.04‐1.37). In conclusion, antibiotic exposure in infancy was associated with a slightly increased risk of childhood overweight and obesity, mainly if children were exposed to repeated treatments or treatment within the first 6 months of life. It is unclear whether this association is mediated via direct effects of antibiotics on the gut microbiota.     

Influence of ethnicity and socioeconomic factors on outcome after total hip replacement

Scand J Caring Sci; 2013; 27; 139–146 Influence of ethnicity and socioeconomic factors on outcome after total hip replacement Background: Previous studies have documented ethnic differences in the utilization of total hip arthroplasty. Less is known if this operation is performed at the same stage of symptoms and has equal effects in patients with different ethnicity. Aim: We investigated whether patients born outside Sweden report equal effects of operation with the insertion of a total hip replacement in terms of EQ‐5D, pain and overall satisfaction as those born in Sweden. Method: Preoperative and 1‐year postoperative data from Swedish Hip Arthroplasty Register, (1216 patients,1216 hips) with primary osteoarthritis of the hip operated between years 2002 and 2006, were analysed. All patients completed the EQ‐5D form, filled in a VAS about pain preoperatively and at 1 year postoperatively, when a VAS about overall satisfaction was added. Findings: Before the operation and after adjustment for confounders, patients born abroad reported more problems (dichotomized into no or moderate/severe problems), with self‐care (p = 0.01) and anxiety/depression (p = 0.02) in the EQ‐5D form than those born in Sweden. They also had more pain (VAS, p = 0.04). One year after the operation and after statistical adjustments, patients born outside Sweden reported lower scores for self‐care (p = 0.008) and usual activities (p = 0.001) in the EQ‐5D form. They still reported more pain (VAS, p = 0.02), but no significant difference concerning degree of satisfaction (p = 0.3). Conclusions: Our finding of more preoperative disability and pain (VAS) before the operation in patients born abroad might depend on cultural differences, communication problems and differences in indications. Even if the effect of the total hip replacement was good, patients born abroad scored less for some of the items at 1 year. We think that this patient group could benefit from improved pre‐ and postoperative information and other measures to facilitate and improve their rehabilitation.