Real life results of rituximab in treatment of active rheumatoid arthritis
Authors:
K. Pavelka 1; K. Chroust 2; L. Burešová 2
Authors place of work:
Revmatologický ústav Praha, 2IBA Masarykova Univerzita, Brno
1
Published in the journal:
Čes. Revmatol., 19, 2011, No. 3, p. 112-117.
Category:
Original Papers
Summary
Authors present report on application of rituximab (RTX) in indication rheumatoid arthritis (RA) in patients treated in Czech Republic in National registry ATTRA. Indications for therapy with RTX according Guidelines of Czech Rheumatologic Society was RA (DAS 28 > 5,1) and failure of at least one disease modifying drug of RA (DMARD) and one anti TNF. Altogether 242 patients were included in the study, 81 % women, mean age was 52 years and duration of disease 12 years. Patients have been treated in the past by average 3 DMARDs and one anti TNF. RTX was given as first biological to 24 % of patients. The activity of RA was high at baseline, but there was significant decrease of activity at week 16 and this effect was sustained after 2 years of follow up in all measured parameters. Status of low disease activity (LDA) DAS 28 < 3,2 was reached in 15,5 % of patients at week 16 and 41,4 % at week 56. All patients, who achieved LDA at week 16 had LDA at week 56. EULAR good and moderate response was achieved in > 80 % patients. Serious adverse events were present in 11,6 %. The most frequents adverse events were serious infections at frequency 13,3/1000 pts. yrs. Serious infusion allergic reactions, leading to interruption of therapy were present in 13,3 / 100 pts. yrs. of patients.
Conclusions:
Open, cohort study of patients in registry, reflects routine clinical practice. In has shown good ratio efficacy / safety of RTX in patients with active RA. Despite the fact that was cohort of patients with longstanding, refractory RA, it was possible to reach low disease activity in more than 40 % patients after 12 months of therapy.
Key words:
rheumatoid arthritis, rituximab, biological therapy
Zdroje
1. Emery P, Fleischmann R, Filipowicz Sosnowska A, a spol. The efficacy and safety of rituximab in patients with active rheumatoid arthritis despote methotrexate treatment: results of phase II. double blind, placebo controlled, dose ranging trial (DANCER). Arthritis Rheum 2006;54:1390-400.
2. Cohen DSB, Emery P, Greenwald MW a spol. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: results of a multicenter, randomized, double blind, placebo controlled, phase III trial evaluating primary efficacy and safety at twenty two weeks. Arthritis Rheum 2006;54:2793-2806.
3. Keystone E, Emery P, Peterfy C, et al. Rituximab inhibits structural joint damage in patients with rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitor therapies. Ann Rheum dis 2009;68(2):216-21.
4. Smolen J, Keystone EC, Emery P, a spol. Consensus statement on the use of rituximab in patiens with rheumatoid arthritis. Ann Rheum Dis 2007:doi:10.1136/ard.2006. 061002.
5. Emery P, Deodhar A, Rigby WF, a spol. Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo – controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximabęs Efficacy in MTX Inadequate Responders (SERENE). Ann Rheum Dis 2010 in press.
6. Rubbert-Roth A, Tak PP, Zerbini C, a spol. Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid artrhtis: results of a Phase III randomized study (MIRROR). Rheumatology (Oxford) 2010 in press.
7. Tak PP, Rigby FC, Rubbert A, a spol. Rituximab in Combination with Metotrexate (MTX) Significantly Inhibits Joint Damage and Improves Clinical Outcomes in Patients with Early Active RA Who Are Naive to MTX: A Randomized Active Comparator Placebo-Controlled Trial (IMAGE). Arthritis Rheum 2009;60:636.
8. Finckh A, Ciureaa A, Brulhart L a spol.: Which subgroup of rheumatoid arthritis patients benefits from switching to rituximab versus alternative anti TNF agents after previous failure to anti TNF agent. Ann Rheum Dis 2009, doi:10.1136/ard.2008.105064.
9. Pavelka K, Gatterová J, Vencovský J, Šedová L, Chroust K. Rentgenová progrese revmatoidní artritidy v běžné klinické praxi – výsledky z českého registru ATTRA. Rheumatologia 2009;1:7-11.
10. Pavelka K, Vencovský J. Doporučení České revmatologické společnosti pro léčbu revmatoidní artritidy. Česká Revmatol 2010;4:180-189.
11. Fransen J, Creemers MC, van Riel P. Remission in rheumatoid arthritis: agreement of the disease activity score (DAS 28) with the ARA preliminary remission criteria. Rheumatology (Oxford) 2004;43:1252-55.
12. Prevoo ML, van Grof HH, Kupper H, et al. Modified disease activity scores that include 28 joint counts development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:44-48.
13. Cruyssen BV, Durez P, Weskovens P, et al. The Belgian MIRA (MabThera in Rheumatoid Arthritis/registry: clues for the optimization of rituximab treatment strategies. Arthritis Res Ther 2010;12:R169.
14. Smolen J, Aletaha D, Bjilsma JW, et atl. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis 2010;69:631-7.
15. Curtis J, jani A, Askling J, et al. A comparison of patient characteristics and outcomes in Selected European and US RA registries. Sem Arthritis Rheum 2010;40:2-14.
16. Pavelka K., Vencovský J. Doporučení České revmatologické společnosti pro léčbu revmatoidní artritidy. Čes Revmatol 2010;4:182-191.
17. Mease PJ, Cohen S, Gaylis MB, et al. Efficacy and safety of retreatment in patients with rheumatoid arthritis with previous inadequate response to TNF inhibitors: Results from SUNRISE trial. J Rheumatol 2010;doi:10.3899/jrheum090442.
18. Keystone E, Fleischmann RM, Emery P, et al. Multiple courses of rituximab produce sustained efficacy in patients with rheumatoid arthritis with an inadequate response to one or more TNF inhibitors. ACR 2010, Abstract.
Štítky
Dermatology & STDs Paediatric rheumatology RheumatologyČlánok vyšiel v časopise
Czech Rheumatology
2011 Číslo 3
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