Leflunomid v současném algoritmu léčby revmatoidní artritidy

Leflunomide in the current treatment algorithm for rheumatoid arthritis

In this review, the authors deal with the position of leflunomide in the treatment algorithm for rheumatoid arthritis (RA). The principles of a modern treatment in RA are mentioned in the introduction. These principles are primarily defined in the „Recommendations“ for the treatment of RA generated by European League Against Rheumatism (EULAR), American College of Rheumatology (ACR) and Czech Society for Rheumatology (CRS). The recommendations emphasize the necessity of early start of disease modifying antirheumatic drugs (DMARDs) treatment, often even prior to establishment of a definite diagnosis of RA. Administration of DMARDs should be flexible, the effective dose can be titrated, and in case of insufficient effect, adjustment of the treatment in three-month intervals is recommended. Combinations of synthetic DMARDs, as well as combinations of synthetic DMARDs with biologic agents are used. The aim of the treatment should be to achieve remission, cessation of radiographic progression, improvement of quality of life and maintenance of ability to work. Leflunomide has been at least as effective as methotrexate (MTX) and sulfasalazine in clinical trials. In the ACR recommendations, leflunomide is regarded as the drug of first choice, equally with MTX, in active RA. CRS recommends MTX as the drug of first choice, and leflunomide as the drug of second choice, when MTX is not well tolerated or has an insufficient efficacy. Leflunomide can also be used in combination both with synthetic DMARDs and biological agents in RA. Although the combination of MTX and leflunomide is not stated in the SPC of the drug, however, based on the analysis of available data and one‘s own experience, ACR and ČRS recommend the combination of MTX and leflunomide providing a selection of suitable patients and a correct safety monitoring. The combination of leflunomide with biologic agents has been assessed in several randomized controlled trials, and several observational studies and registries. The majority of evidence suggests a comparable efficacy of the combination of MTX + biological agent and the combination of leflunomide + biological agent.

Key words:
rheumatoid arthritis, leflunomide

Autori: K. Pavelka; L. Šedová
Pôsobisko autorov: Revmatologický ústav Praha
Vyšlo v časopise: Čes. Revmatol., 17, 2009, No. 4, p. 192-199.
Kategória: Přehledné referáty

Súhrn

Autoři se v přehledném článku zabývají postavením leflunomidu v algoritmu léčby revmatoidní artritidy (RA). V úvodu jsou uvedeny principy moderní léčby RA. Tyto principy jsou definovány především v “Doporučeních” pro léčbu RA Evropské ligy proti revmatismu (EULAR) Koleje amerických revmatologů (ACR) a České revmatologické společnost (ČRS). Zdůrazněn je fakt časného nasazení chorobu modifikujících léků (DMARD), často ještě před stanovením definitivní diagnózy RA. DMARD se podávají flexibilně, titruje se účinná dávka a v případě nedostatečného efektu je doporučeno ve 3měsíčních intervalech adjustovat léčbu. Používají se kombinace syntetických DMARDs i kombinace syntetických DMARDs s biologiky. Cílem léčby musí být remise, zástava rentgenové progrese, zlepšení kvality života a zachování pracovní schopnosti. Leflunomid byl v klinických studiích nejméně tak účinný jako metotrexát (MTX) a sulfasalazin. V ACR Doporučeních je leflunomid uváděn jako rovnocenný lék 1. volby s MTX u aktivní RA. ČRS doporučuje jako lék 1. volby MTX a leflunomid jako lék 2. volby při netoleranci MTX, nebo jeho nedostatečné účinnosti. Leflunomid lze použít též v kombinaci se syntetickým DMARDs i s biologickými léky RA. Kombinace MTX + leflunomid sice není v SPC léku, nicméně ACR i ČRS na základě analýzy dostupných dat a vlastních zkušeností kombinaci MTX + leflunomid doporučují za předpokladu výběru vhodných pacientů a správného monitorování bezpečnosti. Kombinace leflunomid s biologickými léky byla hodnocena v několika randomizovaných, kontrolovaných studiích a řadě observačních studií a registrů. Převážná evidence ukazuje stejnou účinnost kombinace MTX + biologika jako leflunomid + biologika.

Klíčová slova:
revmatoidní artritida, leflunomid

MZ ČR č. MZO 00023728

Prof. MUDr. Karel Pavelka

Revmatologický ústav

Na Slupi 4

128 50 Praha 2

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