Original article
Vol. 143 No. 4950 (2013)
RAISE – Rheumatoid Arthritis Independent Swiss Treatment Expectations and Outcome: results for the abatacept subpopulation
- Jean Dudler
- Roland Tuerk
- Thomas Handschin
- Adrian Forster
Summary
QUESTIONS UNDER STUDY: Clinical trials do not necessarily reflect the results obtained in daily clinical practice. By conducting a non-interventional, observational study with biologics in rheumatoid arthritis (RA) patients in Switzerland, we aimed to generate real-world data on reasons for treatment initiation and discontinuation, physicians’ expectations for treatment, co-medication, and various treatment outcome parameters.
METHODS: Sixty-nine patients with a confirmed diagnosis of RA were included in this non-interventional observational study. Participating physicians used standardised questionnaires to collect data on the use of biologics at three visits over one year. Due to the small sample size of patients receiving biologics other than abatacept, only patients treated with abatacept were considered for analysis.
RESULTS: The population receiving intravenously administered abatacept consisted of 56 patients. Of these, 25% received abatacept as a first-line biologic therapy. The retention rate over one year was high (75%) and similar to what has been previously observed in randomised clinical trials. Overall, abatacept was found to be effective in patients irrespective of their baseline disease activity or levels in C-reactive protein and erythrocyte sedimentation rate. Moreover, the use of glucocorticoids was found to be reduced under therapy. There was a tendency for better treatment outcomes and physicians’ satisfaction with abatacept the earlier the drug was used in the sequence of biologic therapies.
CONCLUSIONS: The present study suggests that abatacept is an effective and well tolerated treatment in RA patients in routine clinical practice, irrespective of disease parameter at baseline.
References
- Gabriel SE. The epidemiology of rheumatoid arthritis. Rheum Dis Clin North Am. 2001;27(2):269–81.
- Nam JL, Winthrop KL, van Vollenhoven RF, Pavelka K, Valesini G, Hensor EM, et al. Current evidence for the management of rheumatoid arthritis with biological disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of RA. Ann Rheum Dis. 2010;69(6):976–86.
- Gaujoux-Viala C, Smolen JS, Landewé R, Dougados M, Kvien TK, Mola EM, et al. Current evidence for the management of rheumatoid arthritis with synthetic disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2010;69(6):1004–9.
- Kvien TK, Mikkelsen K, Nordvåg BY. Results from controlled clinical trials: how relevant for clinical practice? J Rheumatol. 2003;30(6):1135–7.
- Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1988;31:315–24.
- Prevoo ML, van’t Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:44–8.
- Zufferey P, Dudler J, Scherer A, Finckh A. Disease activity in rheumatoid arthritis patients at initiation of biologic agents and 1 year of treatment: Results from the Swiss SCQM registry. Joint Bone Spine. 2012 Jul 4. [Epub ahead of print]
- Westhovens R, Robles M, Ximenes AC, Nayiager S, Wollenhaupt J, Durez P, et al. Clinical efficacy and safety of abatacept in methotrexate-naive patients with early rheumatoid arthritis and poor prognostic factors. Ann Rheum Dis. 2009;68(12):1870–7.
- Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, et al. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2006;144:865–76.
- Dougados M, Kremer JM, Le Bars M, Reed D, Park S, Vatsanos G, et al. Abatacept improves disease activity status over time in patients with rheumatoid arthritis and an inadequate response to methotrexate [abstract]. Ann Rheum Dis. 2009;68:573.
- Schiff M, Keiserman M, Codding C, Songcharoen S, Berman A, Nayiager S, et al. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis. 2008;67:1096–103.
- Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med. 2005;353(11):1114–23.
- Gorter SL, Bijlsma JW, Cutolo M, Gomez-Reino J, Kouloumas M, Smolen JS, Landewé R. Current evidence for the management of rheumatoid arthritis with glucocorticoids: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2010;69(6):1010–4.
- McDonough AK, Curtis JR, Saag KG. The epidemiology of glucocorticoid-associated adverse events. Curr Opin Rheumatol. 2008;20(2):131–7.
- Sibilia J, Flipo RM, Combe B, Gaillez C, Le Bars M, Poncet C, Elegbe A, Westhovens R. L’abatacept Confère une Efficacité Clinique Indépendamment du Niveau de CRP à l’Inclusion Chez les Patients Présentant une Polyarthrite Rhumatoïde et une Réponse Inadaptée au Methotrexate (MTX) dans l’Étude AIM. Congrès SFR; Paris, France; 11–14 Dec 2011. Poster Presentation: Me 115
- Bathon J, Robles M, Ximenes AC, Nayiager S, Wollenhaupt J, Durez P, et al. Sustained disease remission and inhibition of radiographic progression in methotrexate-naive patients with rheumatoid arthritis and poor prognostic factors treated with abatacept: 2-year outcomes. Ann Rheum Dis. 2011;70(11):1949–56.
- Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, et al. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2006;144(12):865–76.
- Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med. 2005;353(11):1114–23.
- Durez P, Bathon J, Becker JC, Covucci A, Moniz Reed D, Westhovens R. Time course of improvement in ACR core components in patients with early rheumatoid arthritis treated with abatacept plus methotrexate. Poster FRI0201, EULAR Annual Congress, June 16–19, 2010.
- Westhovens R, Moniz Reed D, Becker J-C, Vratsanos G, Yazici Y. Early improvements in disease activity with abatacept continue to increase or are maintained over time in methotrexate-naïve patients with early rheumatoid arthritis and poor prognostic factors. Poster SAT0109. EULAR Congress, 10–13 June, 2009.
- Genovese MC, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, et al. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum. 2011;63(10):2854–64.