Patients’ views about treatment with combination therapy for Rheumatoid Arthritis: a comparative qualitative study

Combination therapy has been proven through randomised controlled trials as effective in the early disease process of Rheumatoid Arthritis (RA) [1‐3]. It is now accepted that initial combination therapy and biologic agents are more effective than single disease-modifying anti-rheumatic drugs (DMARDs) [4]. However biologics are not the first treatment of choice in early RA, combination of DMARDs is the first option. The debilitating effect of early RA, short-term functional impairment is mostly caused by local and systemic inflammation, whereas long-term untreated inflammation leads to structural, functional and irreversible damage [5]. There have been concerns amongst rheumatologists about the side-effects, risks and complications of DMARDs and the newer biologics [1]. There are major differences in the costs of treatments, with most conventional DMARDs costing less than £1,000 per year, whilst most biologics including tumour necrosis factor (TNF) inhibitors, cost almost £10,000 per year [6]. In addition health expectations of patients also play a role what treatment can be realistically offered [7]. Three recent qualitative studies [1, 7, 8] tried to capture the views of providers and recipients of this new treatment and its combination. Patients’ responses to the newly offered treatment in early RA tended to be more positive in comparison to rheumatologists who expressed a degree of reluctance in prescribing lots of medication. This divergence is not new in RA care, as highlighted in the literature in relation to physical and psycho-social aspects of rheumatology care and its management [9‐12]. This draws attention to how clinician rated treatments may not coincide with the views of patients with RA for example. In return such disagreement may interfere with patients’ cooperation when responding to their individually tailored needs. Against this background of current sea change in the treatment of RA, the aim of our study was to explore expectations, the impact on quality of life, concerns and management of patients with newly diagnosed and established RA when in receipt of combination therapy.

We decided to undertake a qualitative interview study to obtain greater detailed understanding of patients’ daily experiences, expectations and potential difficulties managing their combination therapy. During outpatient clinic time patients are routinely asked to complete questionnaires, e.g. Health Assessment Questionnaires, Disease Activity and Visual Analogue Scores to assess their clinical outcomes. In discussion with patients they expressed lack of motivation over time in filling in these measures. In their opinion the given answers do not reflect the daily reality of living with RA and self-management. Obtaining of qualitative data via focus groups was also considered, but proofed difficult to arrange due to patients other commitments, e.g. work, family duties, caring for others.

Patients with early RA (8/18) all received combined DMARDs. Participants with established RA (10/18) received either combined DMARDs (5/18) or DMARDs combined with biologics (5/18). Detailed inspection of the qualitative data identified four emerging themes within the analytical framework, which showed some differences between patients with early (n = 8) and established RA (n = 10). These themes comprised: (i) patients’ expectations about combined therapy; (ii) the impact of treatment on quality of life; (iii) concerns about combined treatment; and (iv) management of combined therapy at home.

To our knowledge this is the first qualitative study that examined systematically in patients with early and established RA their expectations, impact on quality of life, concerns about side effects and the management of the treatment when taking combined medication with DMARDs or DMARDs and biologics. There was no notable difference by gender, ethnicity, age and disability in patients’ accounts.

Decisions by medical staff to prescribe combined therapy, according to the patients’ understanding, were ‘the disease was not well controlled’ and ‘monotherapy was not effective enough’ were patients’ views and show the diversity of expressions used. Although the notions are related they may not mirror the medical categories used, e.g. no response, incomplete response or response to treatment.

Within our analytical framework three key messages emerged that appear relevant for clinical practice. Firstly, patients’ expectations about the combined treatment focused mainly on their physical symptoms and concerns about the side effects. Secondly, patients reported that the efficacy of the treatment and its subsequent benefit on their quality of life was mixed. A subgroup of patients on DMARD and biologic seemed to be particularly satisfied with the treatment offered and their quality of life. Finally most patients were able to manage their combined treatment at home, for some with additional electronic or memory aids in close ongoing dialogue and support from the clinic staff. This was also highlighted in the literature [28].

During the interviews many patients alluded to the diverse impact that RA has on their lives with its fluctuating nature. However, we decided to exclude these accounts from this paper, as published elsewhere [28, 29] and to report the key messages that emerged from the interviews.

The introduction of DMARDs when used in combination are prescribed in varying speed during consultations, depending on patients’ medical and emotional circumstances, with the need to continually modify DMARD treatment. These may result in a range of disease activity scores and influence patients’ perceptions. Moreover, intermittent gluco-corticoide treatment is often used as part of intensive combination treatment that may influence patients’ views.

One published qualitative interview study focusing on patients’ perception following commencement of anti-TNF therapy [8] reached similar findings, e.g. how physical functions may improve and high expectations of some patients were not always met. Given the long-term disabling effect of RA, the guidelines of National Institute for Health and Clinical Excellence (NICE) [30] recommended the benefits of particular combined DMARDs in early and established RA. In addition “treat to target” is now commonly recommended and its use is supported by a number of studies [31].

Our findings resonate broadly with the collaborative management of chronic illness model [23] that consists of four elements, e.g. (i) collaborative definition of problems, (ii) goal setting and planning; (iii) training and support in self-management and (iv) active and sustained follow-up. Patients’ contribution to their self-care and its medical care are clearly complementary, rather than in competition. Both parties depend on each other for reaching the goal of controlling the disease activity, joint erosion and pain, including the management of their daily activities of living and medication, within the context of patients’ lives.

What von Korff’s elements’ of care framework offer is an improvement of long-term illness in a structured and explicit way. Within the context of our study findings, three of the four aspects of the model were adhered to by staff and patients, whereas overt goal setting and planning did not receive much attention. However it has become evident from von Korff’s publications in chronic disease management that an effective collaborative care approach strengthens and supports patients’ self-care in long-term disease such as Rheumatoid Arthritis, including their family members and carers.

The treatment of patients with RA is in a stage of constant flux, due to new emerging evidence about treatment modalities. At each stage of such treatment alterations, obtaining patients’ agreement will be imperative, as they also need to understand and ideally adapt to these changes. As is well known within clinical practice, medication concordance is a complex and highly personal issue that needs careful consideration when prescribing medication in close collaboration and concurrence with patients.