Conventional combination treatment versus biological treatment in methotrexate-refractory early rheumatoid arthritis: 2 year follow-up of the randomised, non-blinded, parallel-group Swefot trial.

BACKGROUND: Analysis of the Swedish Farmacotherapy (Swefot) trial at 12 months showed that the addition of an anti-tumour-necrosis-factor agent gave an improved clinical outcome compared with the addition of conventional disease-modifying antirheumatic drugs in patients with methotrexate-refractory early rheumatoid arthritis. Here we report the 2 year follow-up assessment. METHODS: In this randomised, non-blinded, parallel-group trial, we enrolled adult patients older than 18 years with rheumatoid arthritis and a symptom duration of less than 1 year from 15 rheumatology units in Sweden between December, 2002 and December, 2006. All patients were started on methotrexate. After 3-4 months, those who failed treatment were randomly assigned (1:1) to group A (conventional treatment; additional sulfasalazine and hydroxychloroquine) or group B (biological treatment; additional infliximab). Randomisation was done with a computer-generated sequence. We analysed clinical outcomes at months 18 and 24 by the response criteria of the American College of Rheumatology and the European League Against Rheumatism, and radiographs of patients' hands and feet at months 12 and 24 using the Van der Heijde modification of the Sharp score. Analysis was by intention to treat. This trial is registered with www.ClinicalTrials.gov, number NCT00764725. FINDINGS: Of 493 screened individuals, we enrolled 487, of whom 258 were randomly allocated to treatment. The proportion of patients in group B who received a EULAR-defined good response was non-significantly greater than it was in group A at 18 months (49 of 128 [38%] vs 38 of 130 [29%]) and at 24 months (49 of 128 [38%] vs 40 of 130 [31%]; p=0·204). After 24 months, radiological disease progression was greater in patients in group A than it was in those in group B (mean 7·23 [SD 12·72] vs 4·00 [10·0]; p=0·009). We recorded three serious adverse events: an extended generalised illness in group A, an extended febrile episode in group B, and a generalised illness in group B. INTERPRETATION: Additional biological treatment is a valid option for patients who fail initial methotrexate treatment. However, improved clinical outcomes after 12 months and better radiographical results after 24 months should be weighed against the absence of a convincing clinical difference at 24 months and substantially higher costs. Therefore, for many patients who fail initial methotrexate treatment, add-on treatment with disease-modifying antirheumatic drugs is an appropriate treatment option. FUNDING: Swedish Rheumatism Association, Stockholm County, and Schering-Plough/Merck Sharp and Dohme.

Team care. Traditions and new trends.

Major changes have occurred in the care of patients with rheumatic diseases over the past decades. Most of these changes have focused on new pharmacological and surgical procedures and methods. However, for different reasons, few of these methods are available to many patients around the world, and thus other forms of care are still needed. For optimal benefit to patients, all aspects of care should be organized and coordinated through team care. This leads to new trends in team care development and research, based on well established traditions and accumulated knowledge.

Design issues and priorities in team and nonpharmacological arthritis care research.

Nonpharmacologic and team care research present unique design challenges. Nonpharmacologic care by nature is multifaceted and complex. Rarely do patients receive an intervention in isolation. The delivery of a single or group of interventions can be provided by one provider but is frequently provided by teams. Therefore, it is imperative that clinical researchers design studies that evaluate single and multimodal interventions as well as studies that best reproduce the team model of service delivery to accurately examine interventions. While it is well accepted that the research question drives the design, it is imperative to recognize that certain aspects of nonpharmacologic and team care restrict the implementation or effectiveness of specific design components. For example, as patients are required to actively engage in lifestyle changes, double-blinding cannot be employed. In addition, there is no accepted operational definition of team care in arthritis. It is important to keep in mind the characteristics of these interventions in the selection of a research design and develop strategies to best examine these interventions. Combining aspects of randomized controlled trials with qualitative methods is one technique to enrich data collected on these interventions. Certain features of pharmacovigilance studies may also serve as an alternative model. The use of national or regional registries for longterm clinical followup as seen in orthopedic surgery may prove to be applicable in the design of studies for evaluation of team care. Our article will discuss issues related to the design and synthesis of arthritis care research, and the role of patients in the design of clinical trials; describe collaborative international activities furthering team and nonpharmacological arthritis care research; and identify research activities that may influence future practice and the health of people with arthritis.

A nurse-led rheumatology clinic's impact on empowering patients with rheumatoid arthritis: A qualitative study.

The aim of this study was to describe a nurse-led rheumatology clinic's impact on empowering patients with rheumatoid arthritis (RA). Rheumatoid arthritis is a chronic, inflammatory disease that attacks many joints, causing considerable functional restrictions for patients. Consequently, these patients are dependent on a wide variety of health-care services. A descriptive, qualitative design inspired by phenomenography was chosen. The conceptions were collected through interviews with 16 strategically selected patients with RA. Three descriptive categories comprising eight conceptions emerged: teaching (gaining insight and receiving information), regular review (receiving security, realizing regularity, and achieving accessibility), and attention (getting a holistic assessment, receiving coordinated care, and getting sufficient time). A nurse-led rheumatology clinic can be a source for empowering patients with RA to adopt new stances to alternative actions and achieve a higher level of faith in their own abilities.

Perception of tactile massage as a complement to other forms of pain relief in rheumatic disease.

OBJECTIVE: To investigate how patients with rheumatic disease perceive tactile massage as a complement to other pain alleviation methods. METHODS: A phenomenographic approach with semi-structured interviews was employed on a strategic sample of 14 patients with various rheumatic diseases, both inflammatory and non-inflammatory, who had been admitted to Spenshult Rheumatic Hospital. RESULTS: Three descriptive categories with a total of nine conceptions emerged. The descriptive categories were: experiencing alleviation, experiencing trust, and gaining insight. Experiencing alleviation described how patients experience relaxation, pleasure and respite. Experiencing trust described how patients experience a sense of security, confirmation and inner peace. Gaining insight described how patients get to know themselves, see possibilities, and experience wholeness. CONCLUSIONS: When caring for patients who have a chronic illness involving considerable changes to their lives, it is important for health professionals not only to be aware of their physical needs but also to take account of the whole person. This study demonstrates the importance of offering patients a complement to conventional treatment. Tactile massage is a method that promotes a holistic view of patients with chronic pain as well as allowing them to find a new focus in terms of the disease and how they cope with it in their daily lives.