Patient experiences, attitudes and expectations towards receiving information about anti-TNF medication: a quantitative study.

The objective of the study was to measure patient attitudes and experience of information received during drug counselling for rheumatoid arthritis (RA) medications. This is a cross-sectional UK postal questionnaire study. Three RA patient groups-disease-modifying antirheumatic drugs (DMARDs) only, first anti-tumour necrosis factor (anti-TNF) and failed anti-TNF-were sent postal questionnaires. Data on patient history/demographics, drug counselling experience, knowledge of drug side effects, attitudes to vaccinations, cancer screening and blood borne virus testing was collected; 264/679 (39%) patients responded (median age 65 years, 66% female, median disease duration 15 years). Drug information from rheumatology nurses, rheumatology doctors and information leaflets was most useful. Thirty-eight percent of respondents felt reassured by information received, but 37% felt more worried. Forty percent of participants were aware of important drug side effects. Although 42-65% of patients understood they should temporarily halt anti-TNF therapy with concurrent infection, 75% of patients recalled continuing therapy despite infection. Thirteen percent believed that all vaccinations (including travel vaccinations) were safe while taking anti-TNF. Uptake of UK cancer screening programmes was between 87 and 94%, except prostate screening (47%). Most participants were not aware that they may need to discontinue their anti-TNF if they developed cancer. The majority of participants felt neutral/reassured by the prospect of viral hepatitis (95%) and HIV (91%) testing. Although drug counselling is a well-established part of clinical care, there is potential for further improvement to ensure that patients' knowledge empowers them to act safely. Particular areas for improvement included the following: patients halting DMARDs/anti-TNF therapy during infections, knowledge regarding vaccinations and prostate cancer screening uptake.

Patient experiences, attitudes and expectations towards receiving information about anti-TNF medication--"It could give me two heads and I'd still try it!".

BACKGROUND: Anti-tumour necrosis factor (anti-TNF) therapies are an important recent development in the treatment of autoimmune disease. Despite important side effects relating to immune suppression, there is lack of research into patient experiences, attitudes and expectations about the information they receive prior to starting anti-TNF therapy. METHODS: In May 2011 participants were purposively sampled to form two focus groups varying in age, anti-TNF agent and pre-therapy disease activity. A semi-structured topic guide was used to explore patients' experiences regarding the information they received prior to commencing anti-TNF therapy. The focus groups were audio-taped and transcribed verbatim. Data were analysed using content analysis. RESULTS: Four key themes were identified.Firstly, weighing the risks and benefits of anti-TNF therapy. However, most participants attached limited importance to side effects, saying their strong desire for RA symptom control was overriding. Two reported deliberately concealing illness in order to continue their medication. Secondly, the desire for information. They suggested that counselling should occur at an early stage and not during a severe RA flare-up. Thirdly, the process of starting anti-TNF. Many identified that their biggest worry was whether they would be eligible for the new medication. They remembered little about the investigations they underwent, and none said they would have objected to being tested for blood borne viruses. Finally, the experience of being on anti-TNF. Most were positive, describing effects on quality of life as well as symptoms. CONCLUSIONS: The use of qualitative methodology in this study has enabled an understanding of patients' attitudes towards receiving information about anti-TNF therapy. The results may be useful to health professionals in terms of the timing and content of the information given to patients prior to commencing anti-TNF therapy.

Effect of psychological distress on continuation of anti-tumor necrosis factor therapy in patients with rheumatoid arthritis.

OBJECTIVE: To investigate the relationship of psychological distress and associated factors with continuation of tumor necrosis factor (TNF) antagonist therapy in patients with rheumatoid arthritis (RA). METHODS: Patients about to start therapy with TNF antagonists (n = 166) were assessed for psychological distress using the Hospital Anxiety and Depression Scale (HADS). A core set of demographic and clinical variables, including comorbidities from medical records and cigarette smoking history by questionnaire, were recorded at baseline and regular intervals thereafter. Cox proportional hazards regression analysis was used to assess the likelihood of patients discontinuing therapy over a 36-month followup period. RESULTS: The number of years smoked was associated with anxiety (HADS-A; p for trend = 0.008) and general psychological distress (HADS-Total; p for trend = 0.03). In univariate analyses, earlier discontinuation was associated with these variables at baseline: anxiety (HADS-A), depression (HADS-D), abnormal mood (HADS-Total), smoking history (> 30 pack-yrs), years smoked (> 30 yrs), current smoking, high Disease Activity Score 28-joint count (DAS28), poor patient global assessment, and evidence of cardio/cerebrovascular disease (CVD). In multivariate analyses, the strongest predictors of discontinuation were HADS-Total, smoking history (> 30 pack-yrs), DAS28, and evidence of CVD at baseline. CONCLUSION: Discontinuation of therapy with TNF antagonists is independently associated with psychological distress, heavy smoking, and CVD at baseline.

Depression in RA patients treated with anti-TNF is common and under-recognized in the rheumatology clinic.

OBJECTIVES: Depression is common in RA and may be influenced by both disease activity and severity. The aims of this study were to investigate the prevalence of depression in RA patients starting anti-TNF therapy, to investigate how mood alters after exposure to anti-TNF and to determine whether depression is recognized and appropriately managed in the clinic. METHODS: Patients starting anti-TNF therapy were assessed for depression using the Hospital Anxiety and Depression Scale (HADS-D), and classified as depressed with an HADS-D of > or =8. Change in mood was assessed at 6 weeks, 4 months and 12 months. Disease activity data were recorded at baseline, 3 and 12 months. Patients who remained persistently depressed at 4 months had their clinical case notes reviewed to determine whether their low mood had been recognized or treated. RESULTS: Depression was common in this cohort. Depressed patients had higher disease activity scores (DAS28) at all time points, and patients with persistent depression had smaller reductions in DAS28 [median (interquartile range or IQR) change DAS28 1.71 (0-2.6) vs 2.2 (1.5-3.2); P = 0.005]. Only 57% (13/23) patients with persistent depression at 4 months had their depression recognized or managed within the rheumatology clinic. CONCLUSIONS: Depression is common but under-recognized in RA patients starting on anti-TNF therapy. Patients with persistent depression tended to respond less well to anti-TNF, with smaller reductions in DAS28. Given that a significant reduction in DAS28 is a requirement for continuing therapy, recognition and appropriate management of depression may improve TNF effectiveness.

Relationship between pack-year history of smoking and response to tumor necrosis factor antagonists in patients with rheumatoid arthritis.

OBJECTIVE: To determine whether there is a quantitative relationship between smoking history and response to therapy with tumor necrosis factor (TNF) antagonists. METHODS: A history of cigarette smoking was obtained from a questionnaire completed by each patient starting therapy with TNF antagonists since 2002 (n=154). A core set of demographic and clinical variables was recorded at baseline and at 3 and 12 months. The extent of smoking was quantified in pack-years (py), with 1 py equivalent to 20 cigarettes per day for 1 year. The association between smoking intensity and response was assessed using contingency tables and logistic regression analysis. Response to therapy was defined according to the European League Against Rheumatism improvement criteria. RESULTS: There was an increasing trend of no response at 3 and 12 months with increasing py history [p (trend)=0.008 and 0.003, respectively]. The change in Disease Activity Score (DAS)28 over the first 3 months was inversely associated with the number of py (r=-0.28, p=0.002). The association of py history with response failure was independent of age, sex, disease duration, baseline disease activity score (DAS28), Health Assessment Questionnaire (HAQ) score, IgM rheumatoid factor, and smoking at baseline. The most significant effect was seen in patients treated with infliximab. CONCLUSION: RA patients with a history of smoking were more likely to show a poor response to TNF antagonists. Response failure was associated with the intensity of previous smoking, irrespective of smoking status at initiation of anti-TNF therapy.

Nodular disease in rheumatoid arthritis: association with cigarette smoking and HLA-DRB1/TNF gene interaction.

OBJECTIVE: To investigate the association of nodular disease in rheumatoid arthritis (RA) with smoking, seropositivity, and polymorphisms at HLA-DRB1 and TNF loci. METHODS: Consecutive patients with RA (n = 420) attending a hospital clinic were examined for the presence of subcutaneous nodules. Rheumatoid factor (RF) status and HLA-DRB1 genotype were determined on every patient, and their smoking history was recorded. TNFa microsatellite polymorphisms were examined in a subgroup of 144 patients. The relationships between smoking, RF status, HLA-DRB1 genotype, TNFa microsatellite polymorphism, and the presence of nodules were examined using chi-square tests and logistic regression analyses. RESULTS: Current smokers were more likely to have nodular disease than those who had never smoked (OR 1.8, 95% CI 1.0-2.9). An association was also found between RF positivity and nodular disease (OR 2.2, 95% CI 1.2-3.8) that remained significant after correction for current smoking. A combination of current smoking and seropositivity increased the risk of nodular disease (OR 3.9, 95% CI 1.7-9.1). Analysis of HLA-DRB1 genotypes in this RA population revealed that only DRB1*0401 homozygotes were associated with nodular disease, and that this was independent of the influence of smoking and seropositivity. Individual TNFa microsatellite alleles were not associated with the presence of nodules, but an interactive effect was found between the TNF a6 allele and homozygosity for DRB1*0401. CONCLUSION: Our data indicate that nodular disease in RA is independently associated with current cigarette smoking, seropositivity, and homozygosity for HLA-DRB1*0401. The latter association involves a possible interaction with the TNF a6 microsatellite allele.

Relationship among the HLA-DRB1 shared epitope, smoking, and rheumatoid factor production in rheumatoid arthritis.

OBJECTIVE: Rheumatoid factor (RF) production in rheumatoid arthritis (RA) is generally associated with more severe disease. In some studies, RF production has been associated with carriage of HLA-DRB1 alleles encoding the RA-associated shared epitope (SE). Patients who smoke are also more likely to be RF positive. In this study, we investigated whether the association between RF production and smoking was influenced by carriage of the SE. METHODS: The smoking histories of 371 RA patients attending a hospital clinic were recorded. RF levels and SE status were determined for every patient, and the associations between the SE, smoking, and RF production were examined. HLA-DRB1 typing was performed using polymerase chain reaction. Results were analyzed using chi-square tests and logistic regression analysis. RESULTS: Patients who had ever smoked were significantly more likely to be RF positive than nonsmokers (odds ratio 2.2, P < 0.0001). This remained significant (P = 0.003) after correction for age, sex, and disease duration in a logistic regression model. An association was also found between RF positivity and carriage of the SE (P = 0.03, after correction for age, sex, and disease duration), but significance was reduced or lost after correction for previous or current smoking (P = 0.05 and 0.09, respectively). Examination of the major SE phenotypes in this RA population by multivariate logistic regression analysis revealed that only DRB1*0401 was associated with RF positivity, and that this was independent of the influence of smoking. CONCLUSION: Our data confirm that RF production in RA patients is associated with smoking. This does not appear to depend on an HLA-DR-restricted immune response. The association of the SE with RF positivity is primarily due to HLA-DRB1*0401. This appears to be independent of the association with smoking, although smoking further increases the likelihood of RF production in DRB1*0401 patients.

Smoking and disease severity in rheumatoid arthritis: association with polymorphism at the glutathione S-transferase M1 locus.

OBJECTIVE: To determine whether the relationship between smoking and disease severity in women with rheumatoid arthritis (RA) is associated with polymorphism at the glutathione S-transferase (GST) M1 locus. METHODS: Genotyping for GSTM1 was carried out using polymerase chain reaction methodology on 164 women with established RA. Smoking history was obtained on each patient. Radiographic damage was measured by the Larsen score, and functional outcome was assessed by the Health Assessment Questionnaire (HAQ). Data were analyzed by multiple regression analyses, with correction for age and disease duration. RESULTS: Ever having smoked was associated with a worse radiographic and functional outcome than was never having smoked. Both past and current smoking were associated with increased disease severity. Stratification by GSTM1 status revealed that polymorphism at this locus affected the relationship between smoking and disease outcome measures. Patients who lacked the GSTM1 gene and had ever smoked had significantly higher Larsen and HAQ scores than did those who lacked the gene and had never smoked. Radiographic outcome in these patients was worse than that in patients who had the GSTM1 gene and who had smoked. The associations were not affected by correction for socioeconomic status. Rheumatoid factor (RF) production was found to be associated with smoking in only the GSTM1-null patients. CONCLUSION: Our data suggest that disease outcome in female RA patients with a history of smoking is significantly worse than in those who have never smoked. Smoking was associated with the most severe disease in patients who carried the GSTM1-null polymorphism. This association may be due in part to a relationship between the GSTM1 polymorphism and RF production in smokers.