ADALIMUMAB (HUMIRA®) – UČINKOVITOST U REUMATOIDNOM ARTRITISU S POSEBNIM OSVRTOM NA RADNU PRODUKTIVNOST

Simeon Grazio

Tumor-necrosis factor-alpha (TNFα) is a pro-inflammatory cytokine demonstrated to play an important role in the pathogenesis of rheumatoid arthritis (RA). Adalimumab is a recombinant human monoclonal antibody to TNFα. In the PREMIER study, when administered in combination with methotrexate (MTX), adalimumab demonstrated that 49% patients with early RA achieved remission. Adalimumab was effective in improving radiographic outcomes, too. At week 28, 52 and 104 of follow-up there was signifi cantly less radiographic progression in combination group (adalimumab/MTX) than in each monotherapy group (adalimumab or MTX), with adalimumab showing better result than MTX. In a large open-label study with active RA, during adalimumab treatment 25% of patients experienced clinical remission and nearly half achieved minimal disease activity. Combining results from different clinical trials adalimumab has demonstrated up to seven years of efficacy among long-standing RA patients when used in combination with MTX. The percentage of patients achieving clinical remission continued to increase after two or more years of continuous treatment with combination therapy. In Health economic outcome study performed in parallel with PREMIER study there was a big reduction of days lost in the combination group (adalimumab/MTX) i  comparison with MTX at year 1 and a difference maintained to year 2. The combination therapy was much more successful in maintaining quality of work than MTX. PROWD study, which was the first one to actually look at job loss as the primary outcome, showed that the combination of adalimumab and methotrexate has the ability to reduce job loss and work time lost when compared to just MTX. Adalimumab is the newest developed anti-TNFα, which not only demonstrated signifi cant and sustained reduction in signs and symptoms and inhibition of radiographic progression, but has also improved functional status, quality of life and work productivity in patients with RA, with acceptable safety profile.

Čimbenik nekroze tumora alfa (TNFα) je proupalni citokin za kojeg je dokazano da ima značajnu ulogu u patogenezi reumatoidnog artritisa (RA). Adalimumab je rekombinantno potpuno humano protutijelo usmjereno prema TNFα. U PREMIER studiji je primjenom kombinacije adalimumaba i metotreksata (MTX) 49% bolesnika s ranim RA postiglo kliničku remisiju bolesti. Adalimumab je bio učinkovit i u poboljšanju radiološki vidljivih oštećenja. U skupini bolesnika koji su primali kombinacijsku terapiju (adalimumab/MTX) na vizitama 28, 52 i 104 tjedna praćenja bilo je značajno manje pogoršanja radiografskih oštećenja u odnosu na monoterapijske skupine (adalimumab ili MTX), s tim da je učinak adalimumaba bio bolji nego onaj MTXa. U velikoj “otvorenoj” studiji bolesnika s aktivnim RA-om, tijekom liječenja adalimumabom 25% bolesnika je imalo kliničku remisiju, dok je gotovo polovica njih dostiglo minimalnu aktivnost bolesti. Kombinirajući rezultate različitih studija pokazana je učinkovitost kombinacije adalimumaba i MTX-a u bolesnika s dugotrajnim RA-om do čak 7 godina praćenja. Postotak bolesnika koji je dostigao kliničku remisiju se nastavio povećavati nakon 2 i više godina liječenja kombinacijskom terapijom. U studiji zdravstvene ekonomike PREMIER, nakon 1 godine, nađeno je značajno veće smanjenje dana izostanka s posla u skupini na kombinacijskoj terapiji (adalimumab/MTX) u odnosu na monoterapiju MTXom, a razlika je održana i nakon 2 godine praćenja. Kombinacijska terapija je bila učinkovitija u održavanju kvalitete rada u odnosu na sam MTX. Rezultati PROWD studije, kao prve studije koja je za primarni ishod imala gubitak posla, je pokazala je da primjena kombinacije adalimumaba i MTX-a rezultira značajno manjom stopom gubitka posla i izgubljenih radnih sati u odnosu na monoterapiju MTX-om. Adalimumab, kao najnovije razvijeni blokator TNFα, je pokazao ne samo značajno i dugotrajno smanjenje simptoma i znakova bolesti i inhibiciju radiografskih oštećenja, već je, pokazao i poboljšanje funkcijskog statusa, kvalitete života i radne produktivnosti bolesnika s RA-om, uz prihvatljiv sigurnostni profil.