Background and objectivesThe 52‐week, randomized, double‐blind, noninferiority, government‐funded NOR‐SWITCH trial demonstrated that switching from infliximab originator to less expensive biosimilar CT‐P13 was not inferior to continued treatment with infliximab originator. The NOR‐SWITCH extension trial aimed to assess efficacy, safety and immunogenicity in patients on CT‐P13 throughout the 78‐week study period (maintenance group) versus patients switched to CT‐P13 at week 52 (switch group). The primary outcome was disease worsening during follow‐up based on disease‐specific composite measures.MethodsPatients were recruited from 24 Norwegian hospitals, 380 of 438 patients who completed the main study: 197 in the maintenance group and 183 in the switch group. In the full analysis set, 127 (33%) had Crohn's disease, 80 (21%) ulcerative colitis, 67 (18%) spondyloarthritis, 55 (15%) rheumatoid arthritis, 20 (5%) psoriatic arthritis and 31 (8%) chronic plaque psoriasis.ResultsBaseline characteristics were similar in the two groups at the time of switching (week 52). Disease worsening occurred in 32 (16.8%) patients in the maintenance group vs. 20 (11.6%) in the switch group (per‐protocol set). Adjusted risk difference was 5.9% (95% CI −1.1 to 12.9). Frequency of adverse events, anti‐drug antibodies, changes in generic disease variables and disease‐specific composite measures were comparable between arms. The study was inadequately powered to detect noninferiority within individual diseases.ConclusionThe NOR‐SWITCH extension showed no difference in safety and efficacy between patients who maintained CT‐P13 and patients who switched from originator infliximab to CT‐P13, supporting that switching from originator infliximab to CT‐P13 is safe and efficacious.
ObjectiveTo assess the perceived quality of care received by people with osteoarthritis (OA) in Norway and explore factors associated with the quality of care.MethodsA national survey in which members of the Norwegian Rheumatism Association with OA registered as their main diagnosis completed a questionnaire. The perceived quality of care was reported on a 17-item OsteoArthritis Quality Indicator questionnaire, covering both pharmacological and non-pharmacological aspects of OA care. In addition, the four-page questionnaire covered areas related to demographic characteristics, the location and impact of the OA, and utilization and satisfaction with health care services. The quality of care is calculated as pass rates, where the numerator represents the number of indicators passed and the denominator represents the number of eligible persons.ResultsIn total, 1,247 participants (response rate 57%) completed the questionnaire. Mean age was 68 years (standard deviation 32) and 1,142 (92%) were women. Respondents reported OA in hand only (12.4%), hip only (7.3%), knee only (10.4%), in two locations (42%) or all three locations (27%). The overall OsteoArthritis Quality Indicator pass rate was 47% (95% confidence interval [CI] 46%–48%), and it was higher for pharmacological aspects (53% [51%–54%]) than for non-pharmacological aspects of care (44% [43%–46%]). The pass rate for the individual quality indicators ranged from 8% for “referral for weight reduction” to 81% for “receiving advice about exercises”. Satisfaction with care was strongly associated with perceived quality. The pass rate for those who were “very satisfied” was 33% (25%–40%) higher than those who were “very unsatisfied” with care.ConclusionWhile the OA patient seems to be rather satisfied with the perceived OA care, there is still room for improvement in the quality of care. Although the quality of care in the present study is somewhat higher than in other studies, less than 50% of the recommended care has been provided.
BackgroundComprehensive rehabilitation, involving health professionals from various disciplines, is widely used as an adjunct to pharmacological and surgical treatment in people with rheumatic diseases. However, the evidence for the clinical- and cost-effectiveness of such interventions is limited, and the majority of those who receive rehabilitation are back to their initial health status six to 12 months after discharge.Methods/designTo evaluate the goal attainment, health effects and cost-effectiveness of a new rehabilitation programme compared to current traditional rehabilitation programmes for people with rheumatic diseases, a stepped-wedge cluster randomized trial will be performed. Patients admitted for rehabilitation at six centres in the south-eastern part of Norway will be invited to participate. In the trial, six participating centres will switch from a control (current rehabilitation programme) to an intervention phase (the new rehabilitation programme) in a randomized order. Supported by recent research, the new programme will be a supplement to the existing programme at each centre, and will comprise four elements designed to enhance and support lifestyle changes introduced in the rehabilitation period: structured goal-planning, motivational interviewing, a self-help booklet and four follow-up telephone calls during the first five months following discharge. The primary outcome will be health-related quality of life and goal attainment, as measured by the Patient Generated Index directly before and after the rehabilitation stay, as well as after six and 12 months. Secondary outcomes will include self-reported pain, fatigue, a global assessment of disease activity and motivation for change (measured on 11-point numeric ratings scales), health-related quality of life as measured by the Short Form 36 Health Survey (SF-36) and utility assessed by the SF6D utility index.The main analysis will be on an intention to treat basis and will assess the clinical- and cost-effectiveness of the structured goal planning and tailored follow-up rehabilitation programme for patients with rheumatic diseases.DiscussionThe findings will constitute an important contribution to more cost-effective- and evidence-based rehabilitation services for people with rheumatic diseases.Trial registrationISRCTN91433175.
Collaboration across the five Nordic biological registries regarding bDMARD use in AS is feasible but national differences in coverage, prescription patterns, and patient characteristics must be taken into account depending on the scientific question.
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