Abstract
The Czech national registry ATTRA collects data from patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and juvenile idiopathic arthritis, treated with the biologic drugs. ATTRA is a prospective centralized computerized registry of patients with a focus on efficacy, safety, and quality of life data. Abatacept is approved as a second-line agent which can be prescribed after a failure of at least one TNF-alfa inhibitor. Data of patients treated with abatacept has been collected since 2008. A statistical analysis of the group of RA patients treated with abatacept was performed recently. ATTRA registered 162 patients with RA treated with abatacept, the mean age 51.0 ± 12.2 (median 53.1, 19–74 years), the mean duration of the disease was 14 ± 9.1, median 11.3 years (0–41). One hundred thirty patients (80.2 %) were female. The mean DAS28 was at week 0, 5.9 ± 1.1, at week 16, 4.1 ± 1.4, at week 24, 3.8 ± 1.2, at week 36, 3.6 ± 1.3, and at week 52, 3.5 ± 1.2. DAS28 remission was achieved at week 16 in 15.8 %, at week 24 in 10 %, at week 36 in 20.9 %, and at week 52 in 20.8 % of patients. Of those patients with a DAS28 <2.6 (remission) at week 16, 58.3 % remained in remission at the week 52. Of those patients with DAS28 >5.1 (high disease activity) at the week 16, only 41.7 % had DAS >5.1 at week 52. One year on treatment survival was 82 %. Altogether 50 non-serious adverse events (AE) were reported in 36 patients (22 %) and 11 serious AE in 10 patients (6 %) with the most common being infections (31) and skin rashes (5). Just one non-serious allergic reaction was reported. Data from the ATTRA registry confirms a good overall efficacy and safety profile and a very good on drug survival with abatacept.
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References
Kremer JM, Westhovens R, Leon M et al (2003) Treatment of rheumatoid arthritis by selective inhibition of T-cell activation with fusion protein CTLA4Ig. N Engl J Med 349:1907–1915
Linsley PS, Brady W, Urnes M et al (1991) CTLA-4 is a second receptor for the B cell activation antigen B7. J Exp Med 174:561–569
Tegzová D, Vencovsky J, Dusek L, Pavelka K (2004) Clinical register of TNF alpha blocking therapy of Czech rheumatologic society. Project ATTRA. Results of study: clinical efficacy and safety. Ann Rheum Dis 63(Suppl 1):263
Prevoo MLL, van ‘t Hof MA, Kuper HH et al (1995) Modified disease activity scores that includes twenty eight- joint counts: development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 38:44–48
Van Gestel AM, Prevoo MLL, van ‘t Hof MA (1996) Development and validation of the European League against Rheumatism response criteria for rheumatoid arthritis. Arthritis Rheum 39:34–40
Prevoo MLL, van Gestel AM, van ‘t Hof MA et al (1996) Remission in a prospective study of patients with rheumatoid arthritis. Br J Rheumatol 35:1101–1105
The EuroQol Group (1990) EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 16:199–208
Jenkinson C, Coulter A, Wright L (1993) Short form 36 (SF36) health survey questionnaire: normative data for adults of working age. BMJ 306:1437–1440
Pincus T, Summey JA, Soraci SA Jr, Wallston KA, Hummon NP (1983) Assessment of patient satisfaction in activities of daily living using a modified Stanford Health Assessment Questionnaire. Arthritis Rheum 26:1346–1353
Kremer JM, Dougados M, Emery P et al (2005) Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve month results of a phase IIb, double-blind, randomized, placebo-controlled trial. Arthritis Rheum 52:2263–2271
Kremer JM, Genant H, Moreland L et al (2006) Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med 144:865–876, 2006
Burmester GR (2012) Remission. Nat Rev Rheumatol. doi:10.1038/nrrheum.2011.201 [Epub ahead of print]
Genovese MC, Becker JC, Schiff M et al (2005) Abatacept for rheumatoid arthritis refractory to tumor necrosis factor in inhibition. N Engl J Med 353:1114–1123
Genovese MC, Schiff M, Luggen M et al (2006) Sustained efficacy and safety through 2 years in patients with rheumatoid arthritis (RA) in the long-term extension of the ATTAIN trial. Arthritis Rheum 54(Suppl 9):247
Dougados M, Schmidely N, Le Bars M et al (2009) Evaluation of different methods used to assess disease activity in rheumatoid arthritis: analyses of abatacept clinical trial data. Ann Rheum Dis 68:484–489
Westhovens R, Luggen M, Russell A et al (2008) Abatacept provides durable improvements in RA disease status and a consistent safety profile through 3 years in the aim and attain trials. Rheumatology 47(Suppl 2):46
Emery P, Kremer JM, Moreland R et al (2008) Long-term efficacy and safety of abatacept through 5 years of treatment in rheumatoid arthritis patients with an inadequate response to methotrexate. Rheumatology 47(Suppl 2):48
Kremer JM, Russell AS, Emery P et al (2011) Long-term safety, efficacy and inhibition of radiographic progression with abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate: 3-year results from the AIM trial. Ann Rheum Dis 70:1826–1830
Schiff M, Bessette L (2010) Evaluation of abatacept in biologic-naïve patients with active rheumatoid arthritis. Clin Rheum 29:583–589
Vital EM, Emery P (2006) Abatacept in the treatment of rheumatoid arthritis. Ther Clin Risk Manag 2:365–375
Russel AS, Wallenstein GV, Li T et al (2007) Abatacept Improves both the physical and mental health of patients with rheumatoid arthritis who have inadequate response to methotrexate treatment. Ann Rheum Dis 66:189–194
Hetland ML, Christensen IJ, Tarp U et al (2010) Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry. Arthritis Rheum 62:22–32
van Riel PL, van de Laar MA Evaluation and monitoring of biologicals in the treatment of rheumatoid arthritis in daily clinical practive. DREAM, Report Winter 2011/2012, Feb 2012, 1–39, unpublished data
Lindblad S, Stawiarz L, Swedish Rheumatology Quality Registry (2012) Gender and prevoius treatment influence outcomes from abatacept in a 5 years cohort of rheumatoid arthritis. Ann Rheum Dis 71(Suppl 3):383, Abstract
Leffers HC, Osterggard M, Glintborg B et al (2011) Efficacy of abatacept and tocilizumab in patients with rheumatoid arthritis treated in clinical practice: results from the nationwide Danish DANBIO registry. Ann Rheum Dis 70:1216–1222
Schiff M, Keiserman M, Codding C et al (2008) Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomized, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis 67:1096–1103
Schiff M, Keiserman M, Codding C et al (2006) The efficacy and safety of abatacept or infliximab in RA patients with an inadequate response to MTX: results from a 1-year double-blind, randomized, placebo-controlled trial. Arthritis Rheum 54(Suppl 1):43
Schiff M, Pritchard C, Teng J et al (2007) The safety of abatacept in patients with active rheumatoid arthritis and an inadequate response to anti-TNF therapy: results from the ARRIVE trial. Ann Rheum Dis 66(Suppl 2):89
Smitten A, Simon R, Qi K et al (2008) Hospitalized infections in the abatacept RA clinical development program: an epidemiological assessment with >10,000 person-years of exposure. Arthritis Rheum 58(Suppl 9):786–787
Weinblatt M, Combe B, Covucci A et al (2006) Safety of the selective costimulation modulator abatacept in rheumatoid arthritis patients receiving background biologic and nonbiologic disease-modifying antirheumatic drugs: a one-year randomized, placebo-controlled study. Arthritis Rheum 54:2807–2816
WHO (1969) The evaluation of drugs: whose responsibility? IOMS Round Table Conference, October 1968. WHO Chron 23:256–263
Singh JA, Wells GA, Christenses R et al. (2011) Adverse effects of biologics: a network meta-analysis and Cochrane overview. Cochrane Database Syst Rev 16;2:CD008794
Gottenberg JE, Ravaud P, Bardin T et al (2010) Prospective follow-up of abatacept treatment in 920 patients with refractory rheumatoid arthritis: tolerance and efficacy data from French ORA (Orencia and rheumatoid arthritis) registry. Ann Rheum Dis 69(Suppl 3):386
Weinblatt ME, Schiff M, Valente R et al (2013) Head-to-head comparison of subcutaneous abatacept versus adalimumab for rheumatoid arthritis. Arthritis Rheum 65:28–38
Acknowledgement
The authors would like to acknowledge all cooperating centers of ATTRA registry: Prof. Karel Pavelka, Institute of Rheumatology in Prague; Marie Sedláčková, MD, Department of Rheumatology, Thomayer Faculty Hospital in Prague; Hana Brabcová, MD, Department of Rheumatology, Faculty Hospital in Plzeň; Prof. Pavel Horák, III, Department of Internal Medicine-Nephrology, Rheumatology, Endocrinology, Palacky University of Olomouc; Ladislav Bortlík, MD, ARTROSCAN, Ostrava; Associate Prof. Petr Bradna, II, Department of Internal Medicine, Faculty Hospital in Hradec Králové; Ivana Součková, MD, Department of Rheumatology, Regional Hospital in Liberec; Zdeněk Fojtík, MD, Department of Rheumatology, Faculty Hospital of Brno; Sevda Augustinová, MD, Medipoint PLUS, České Budějovice; Petr Vítek, MD, PV—Medical, Zlín; Alena Tichá, MD, Rheumatology Clinic Sokolov; Dagmar Galatíková, MD, Rheumatology Clinic Bruntál; Helena Šedivá, MD, Rheumatology Clinic, Ústí nad Labem; Olga Janušková, MD, Rheumatology Clinic, Kroměříž; Eva Dokoupilová, MD, Rheumatology Clinic, Uherské Hradiště; Associate Prof. Petr Němec, Internal Department Rheumatology Clinic, Faculty Hospital Svatá Anna, Brno; Vlastimil Novotný, MD, Rheumatology Clinic, Mariánské Lázně ; Julius Vachtenheim, MD, Rheumatology Clinic Jihlava; Pavla Vavřincová, MD, Rheumatology Clinic, Faculty Hospital Motol, Prague; Klára Šírová, MD, Rheumatology Clinic, Ostrava; Vít Kuba, MD, Rheumatology Clinic Chomutov; Associate Prof. Josef Hoza, Children Hospital Faculty Hospital in Prague; Iva Kielkowská, MD, Faculty Hospital, Ostrava; Zdeněk Dvořák, MD, ARTHROMED, Pardubice; Marie Macků, MD, Children Department , Faculty Hospital, Brno; Jana Korbielová, MD, REDIAMB Havířov; Libor Novosad, MD, L.K.N. Arthrocentrum, Hlučín; Jana Kopačková, MD, ARTMEDI UPD, Hostivice. This study was funded by ATTRA registry, Czech Republic
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Horák, P., Skácelová, M., Hejduk, K. et al. Abatacept and its use in the treatment of rheumatoid arthritis (RA) in the Czech Republic—data from the ATTRA registry. Clin Rheumatol 32, 1451–1458 (2013). https://doi.org/10.1007/s10067-013-2303-6
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DOI: https://doi.org/10.1007/s10067-013-2303-6