Rheumatoid Arthritis: Cifaldi MA

Mittendorf T, Dietz B, Sterz R, Kupper H, Cifaldi MA, von der Schulenburg JM. · Center for Health Economics, Leibniz University Hannover, Hannover; Abbott GmbH Co KG, Ludwigshafen, Germany. · J Rheumatol. · Pubmed #17918788 No free full text.

Abstract: OBJECTIVE: In patients with longstanding severe rheumatoid arthritis (RA) receiving chronic treatment with adalimumab, health related quality of life (HRQOL) was assessed using new instruments [Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue) and Health Utilities Index Mark 3 (HUI3)] and a more conventional instrument [Medical Outcomes Study Short Form-36 Health Survey (SF-36)].METHODS: Different measures for collecting patient-reported outcomes were applied simultaneously during the 3-year study period. Sociodemographic and medical history data were assessed at the baseline visit. Clinical examinations (e.g., joint examination and morning stiffness), disease assessments, and HRQOL data were recorded every 8 weeks. For dichotomous and categorical variables, absolute and relative frequencies were calculated. Metric measures were described using mean and standard deviation and/or standard error of the mean. HRQOL data were analyzed using observed cases. RESULTS: All assessed measures (FACIT-Fatigue, HUI3, SF-36) showed a rapid and statistically significant improvement from baseline following initiation of adalimumab therapy. This effect was maintained over the study period for a mean of 1.6 years in all applied measures. HRQOL data from all tested instruments were significantly correlated with each other. CONCLUSION: Chronic therapy with adalimumab improved measures of fatigue and HRQOL in patients with longstanding RA.

Davies A, Cifaldi MA, Segurado OG, Weisman MH. · United BioSource Corporation, London, UK. · J Rheumatol. · Pubmed #19012363 No free full text.

Abstract: OBJECTIVE: To estimate the comparative lifetime cost-effectiveness of sequenced therapy with tumor necrosis factor (TNF) antagonists as the initial therapeutic intervention for patients with early rheumatoid arthritis (RA). METHODS: Because patients with RA switch regimens many times throughout the course of disease, sequenced therapeutic interventions were modeled, continuing until the last effective agent failed or death occurred. The model used published clinical outcomes from short-term, randomized controlled trials. Direct treatment costs and costs of lost productivity were modeled for each of 5 alternative treatment sequences. Incremental cost-effectiveness ratios are expressed as quality-adjusted lifeyears (QALY) gained. RESULTS: Treatment sequences that included TNF antagonists produced a greater number of QALY than conventional disease modifying antirheumatic drug regimens alone. The cost-effectiveness of sequenced therapy initiated with adalimumab plus methotrexate (MTX) extendedly dominated both infliximab-plus-MTX-initiated and etanercept sequences. The cost of adalimumab plus MTX per QALY was US $47,157 excluding productivity losses, and $19,663 including productivity losses. A supplementary sequence that incorporated adalimumab-plus-MTX-initiated first-line therapy followed by another TNF antagonist as second-line therapy was modeled; this sequence resulted in additional QALY gained and extendedly dominated all single-TNF strategies. CONCLUSION: Of the 3 single-TNF antagonist sequences, the adalimumab-plus-MTX-initiated sequence was cost-effective in producing the greatest number of QALY. Multiple TNF strategies, such as the supplementary sequence modeled in this analysis, may be cost-effective in producing even greater health gain.

Halpern MT, Cifaldi MA, Kvien TK. · Department of Health Policy and Management, Emory University, Atlanta, Georgia 30329, USA. · Ann Rheum Dis. · Pubmed #18829616 links to  free full text

Abstract: BACKGROUND AND OBJECTIVES: Rheumatoid arthritis (RA) causes considerable disability and often results in loss of work capacity and productivity. This study evaluated the impact of adalimumab, a tumour necrosis factor antagonist with demonstrated efficacy in RA, on long-term employment. METHODS: Data from an open-label extension study (DE033) of 486 RA patients receiving adalimumab monotherapy who previously did not respond to at least one disease-modifying antirheumatic drug (DMARD) and had baseline work status information were compared with data from 747 RA patients receiving DMARD treatment in a Norway-based longitudinal registry. Primary outcomes included the time patients continued working at least part time and the likelihood of stopping work. Secondary outcomes included American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) responses and disease remission. Outcomes were compared 6, 12 and 24 months after enrolment. RESULTS: During a 24-month period, the 158 patients who received adalimumab and were working at baseline worked 7.32 months longer (95% CI 4.8 to 9.1) than did the 180 patients treated with DMARDs, controlling for differences in baseline characteristics. Regardless of baseline work status, patients receiving adalimumab worked 2.0 months longer (95% CI 1.3 to 2.6) and were significantly less likely to stop working than those receiving DMARDs (HR 0.36 (95% CI -0.30 to 0.42) for all patients and 0.36 (95% CI 0.15 to 0.85) for patients working at baseline, respectively). The patients who received adalimumab were also considerably more likely to achieve ACR responses and disease remission than DMARD-treated patients. Patients who achieved EULAR good response and remission were less likely to stop working, but this relationship was only seen in patients receiving DMARDs. CONCLUSIONS: Patients with RA who received adalimumab experienced considerably longer periods of work and continuous employment, and greater rates of clinical responses, than patients receiving DMARDs. The mechanism by which adalimumab decreases likelihood of stopping work seems to be different from that of DMARD treatment and independent of clinical responses.

Mittendorf T, Dietz B, Sterz R, Cifaldi MA, Kupper H, von der Schulenburg JM. · Center for Health Economics, Gottfried Wilhelm Leibniz University Hannover, Hannover, Germany. · Rheumatology (Oxford). · Pubmed #18174232 No free full text.

Abstract: OBJECTIVES: This study evaluated the patients' perspective of burden of disease among 505 patients with severe, long-standing rheumatoid arthritis receiving adalimumab. METHODS: Health-related quality-of-life and resource use data were collected during a 144-week open-label study. RESULTS: Adalimumab maintained pain control and reduced the duration of morning stiffness. Work impairment decreased and work productivity was maintained over the duration of the study. Costs were estimated at approximately 2100 euros over the course of the study, and personal help and transportation costs comprised a large percentage of total costs. CONCLUSIONS: These results suggest that adalimumab could improve many aspects of a patient's burden of disease.