Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE)).

OBJECTIVES: This phase III study evaluated the efficacy and safety of rituximab plus methotrexate (MTX) in patients with active rheumatoid arthritis (RA) who had an inadequate response to MTX and who were naïve to prior biological treatment. METHODS: Patients with active disease on stable MTX (10-25 mg/week) were randomised to rituximab 2 x 500 mg (n=168), rituximab 2 x 1000 mg (n=172), or placebo (n=172). From week 24, patients not in remission (Disease Activity Score (28 joints) > or =2.6) received a second course of rituximab; patients initially assigned to placebo switched to rituximab 2 x 500 mg. The primary end point was American College of Rheumatology 20 (ACR20) response at week 24. All patients were followed until week 48. RESULTS: At week 24, both doses of rituximab showed statistically superior efficacy (p<0.0001) to placebo (ACR20: 54%, 51% and 23%; rituximab (2 x 500 mg) + MTX, rituximab (2 x 1000 mg) + MTX and placebo + MTX, respectively). Secondary end points were also significantly improved for both rituximab groups compared with placebo. Further improvements in both rituximab arms were observed from week 24 to week 48. Rituximab + MTX was well tolerated, demonstrating comparable safety to placebo + MTX through to week 24, and between rituximab doses through to week 48. CONCLUSIONS: Rituximab (at 2 x 500 mg and 2 x 1000 mg) plus MTX significantly improved clinical outcomes at week 24, which were further improved by week 48. No significant differences in either clinical or safety outcomes were apparent between the rituximab doses.

Repeatability of standardized tests of functional impairment and well-being in older people in a rehabilitation setting.

PURPOSE: The aim of this study was to establish the repeatability of standardized tests of vision (Snellen chart testing), hearing (whispered voice test), communication (Frenchay aphasia screening test), loneliness (UCLA loneliness scale), morale (Philadelphia geriatric centre morale scale), and a multidimensional instrument (EASY-care) when used in a rehabilitation setting. METHOD: The tests were administered by a research nurse to 50 older subjects attending a day rehabilitation unit, with repeat administration one or two weeks later by a nurse on the unit. Kappa statistics were used for level of agreement for categorized data and interclass correlation coefficient were used for data based on scores. RESULTS: Moderate repeatability for Snellen chart testing. whispered voice test; good to excellent for the FAST, UCLA loneliness scale and Philadelphia geriatric centre morale scale. Moderate to very good repeatability for all EASY-care items except communication, feeding, use of telephone and cognitive impairment, which had poor spread of data. CONCLUSIONS: Poor repeatability for commonly used tests of vision and hearing is worrying, whereas the positive results for the other tests will increase confidence in using them more in routine practice.

Healthy ageing in urban and rural Britain: a comparison of exercise and diet.

OBJECTIVE: to compare exercise levels, and dietary intake of fruit and vegetables in representative samples of healthy elderly people living in rural and urban areas. DESIGN: two-wave (screening followed by face-to-face interview) cross-sectional survey. SETTING: rural Cambridgeshire and urban Nottingham, UK. PARTICIPANTS: 2041 respondents (1021 in Cambridgeshire; 1020 in Nottingham) sampled from general practitioner lists. MAIN OUTCOME MEASURES: self-rated reports of health, exercise and food frequency. RESULTS: within these samples of healthy elderly people, those living in rural Cambridgeshire were significantly more likely to consume fresh fruit [odds ratio (OR) = 1.81, 95% confidence interval (CI) = 1.52-2.16, P < 0.001] and green vegetables (OR = 3.70, 95% CI = 3.07-4.45, P < 0.001) daily in both the summer and winter months. While overall levels of activity were similar for both groups, the structure of activities differed, with the urban sample reporting significantly greater time spent walking. CONCLUSIONS: against current World Health Organisation recommendations for fruit and vegetable consumption, respondents in rural areas reported a substantially 'healthier' diet than their urban peers. On the other hand, urban elderly people may enjoy greater cardiovascular protection from greater time spent walking.

Stability and change in levels of habitual physical activity in later life.

OBJECTIVES: to describe stability and change in levels of customary physical activity assessed in recall-based questionnaire surveys of older people conducted in 1985, 1989 and 1993. DESIGN: longitudinal study. SUBJECTS: 1042 people originally aged 65 and over randomly sampled from general practitioner lists in Nottingham, UK. METHODS: logistic and multiple regression analyses, intraclass correlation coefficients. MAIN OUTCOME MEASURES: self-reported time spent per day walking and shopping; self-reported time spent per week in other indoor, outdoor and leisure activities; frequency of performance of strength and flexibility activities. RESULTS: among survivors, activity levels at baseline tended to be higher than those of their non-surviving peers. Overall, 8-year change between 1985 and 1993 was characterized by progressively declining activity levels. Nevertheless, in both trajectories and stability profiles, differences did emerge among the seven activity categories studied. At least one in four respondents increased the time they spent walking, and approximately one in three respondents increased the time they spent shopping between 1985 and 1993. CONCLUSIONS: these findings suggest that, while some activity variables show levels of stability consistent with trait-like constructs, others are clearly more labile. While the present data cannot offer a definitive explanation for these differences, it seems reasonable that within each activity the influence of ability, opportunity and need interact to determine levels of participation.

A better way to measure disability in older people.

BACKGROUND: Health care experts, older people and carers were asked to weight 18 personal and social activities of daily living (ADLs) with regard to the importance of being able to perform them. RESULTS: All groups agreed on the order of importance but experts gave greater weight to personal ADLs. We have used these results to produce a ratio scale.

Population predictors of community health and social service use in Northern Ireland.

STUDY OBJECTIVE: To investigate the characteristics of elderly populations associated with variations in their use of community health and personal social services and to test the hypotheses that the variations are related to: (a) the age structure of an elderly population; (b) the population's socioeconomic composition, including the level of deprivation; and (c) household or living arrangements. DESIGN: A common file of 1991 population census and 1994 NHS community trust operational variables was constructed for 67 postcode sectors, with the independent variables describing the age-sex groups to be studied. Clear criteria for the exclusion of "empty" sectors were developed. Relationships using bivariate and multivariate correlation and stepwise multiple regression were explored. SETTING: Eastern Health and Social Services Board area, Northern Ireland (Belfast and hinterland). PARTICIPANTS: Population of statutory pensionable age; in aggregate, younger and older age bands. MAIN RESULTS: The age structure or mean age of the elderly population had only a weak association with the community health and social service client rate, but there were strong associations with socio-economic variables, particularly the percentage of those living alone who were without a car and the percentage of pensioner households that included an adult of below pensionable age. Parsimonious multiple regression models accounted for between 46% and 80% of the variation in the NHS community trust client rate. Greater explanations were achieved for the young elderly population than for those aged 75+ years and, when the population was divided between young and old age bands, for men than for women. CONCLUSIONS: Community health and social services for elderly people in eastern Northern Ireland were focused on those with a low income and those who were not co-resident with adults of working age. When local elderly populations are compared, per capita morbidity and dependency are often higher where the mean age is low, and vice versa, because of the inverse relationship between socioeconomic status and survival in old age. Capitation scales for resource allocation with positive age weighting will be of little use if no account is taken of the relative prevalence of need in the youngest or base age group.