Riduzione del Dosaggio di Baricitinib Nei Pazienti con Artrite Reumatoide che Hanno Raggiunto il Controllo della Malattia Prolungato: Risultati di uno StudioProspettico
Takeuchi T,
Genovese MC,
Haraoui B,
Li Z,
Xie L,
Klar R,
Pinto Correia A,
Otawa S,
Lopez-Romero P,
de la Torre I,
Rooney TP,
Smolen JS
Ann Rheum Dis. 2019 Feb;78(2):171-178. DOI 10.1136/annrheumdis-2018-213271
In active RA patients, with an inadequate response (IR) to DMARDs who achieve low disease activity (LDA) following baricitinib (BARI) 4 mg treatment, disease control is better maintained with continued BARI 4 mg compared to tapering to 2 mg.The objective of this study was to investigate the effect of BARI tapering in patients achieving sustained disease control with BARI 4 mg.In the long-term extension study RA-BEYOND, patients receiving BARI 4 mg who achieved sustained LDA or remission at two consecutive visits, were re-randomized to either continue BARI 4 mg or step down to 2 mg. Efficacy and safety were assessed through 48 weeks.Majority of patients in both groups maintained LDA or remission over the 48-week period. Dose reduction resulted in significant increases in disease activity at 12, 24, and 48 weeks, with significantly more patients relapsing over 48 weeks compared to the BARI 4 mg group. In addition, dose reduction was associated with a lower rate of non-serious infections while rates of SAEs and AEs leading to discontinuation were similar across groups.Overall, the data indicate disease control was better maintained on the 4 mg dose than 2 mg. Most stepped-down patients maintained LDA/remission or regained control on return to the 4 mg dose.