Cytokine Signalling Forum

Publications





November 21

Incidence and risk factors for herpes zoster in patients with rheumatoid arthritis receiving upadacitinib: a pooled analysis of six phase III clinical trials

Winthrop KL, Nash P, Yamaoka K, Mysler E, Khan N, Camp HS, Song Y, Suboticki JL, Curtis JR.
Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-220822.

JAKinibs have been linked with an increased risk of HZ in patients with RA. To this end, Winthrop, et al. evaluated data from six Phase III clinical trials to determine the incidence of HZ in the upadacitinib (UPA)-treated patients with RA and identify potential risk factors for the development of HZ in these patients. Analysis of data provides further support for the need for continued vigilance and monitoring for signs of herpes zoster (HZ) in patients receiving UPA, particularly in Asian popu...

December 20

Trocando entre o Inibidor de Janus Quinase Upadacitinib e Adalimumab Depois de Resposta Insuficiente: eficácia e segurança em pacientes com artrite reumatoide

Fleischmann RM, Blanco R, Hall S, Thomson GTD, Van den Bosch FE, Zerbini C, Bessette L, Enejosa J, Li Y, Song Y, DeMasi R, Song I-H.
Ann Rheum Dis 2020; doi:10.1136/annrheumdis-2020-21841220

Both ACR and EULAR recommend adding a biologic or targeted synthetic DMARD in patients who do not achieve treatment goals at follow-up. Findings indicated that an immediate switch in mechanism of action (from JAKi to TNFi and vice versa) following treat-to-target principles is feasible with minimal risk of flare regardless of whether patients are switched due to non-response or incomplete-response. SELECT-COMPARE followed treat-to-target principles to examine the efficacy of switching in two pat...

January 20

Tofacitinib em Combinação com Metotrexato em Pacientes com Artrite Reumatoide: Desfechos Reportados por Pacientes do Estudo de Fase 3 de 24 Meses ORAL Scan

Strand V, van der Heijde D, Tanaka Y, Keystone E, Kremer J, Zerbini C A F, Cardiel M H, Cohen S, Nash P, Song Y-W, Tegzová D, Gruben D, Wallenstein G, Connell C A, Fleischmann R.
Clin Exp Rheumatol . Sep-Oct 2020;38(5):848-857. Epub 2019 Dec 19.

In the ORAL SCAN study, patients receiving TOF 5 mg or 10 mg BID reported significant improvements in patient-reported outcomes at month 3 compared with placebo, which were maintained through 24 months of treatment. RA causes a significant health and socioeconomic burden and affects all aspects of health related quality of life. ORAL Scan included patients with active RA and inadequate response to MTX who were randomised to receive TOF 5 mg or 10 mg BID plus MTX or PBO. This study evaluated the ...

Keywords: JAK, Tofacitinib, Clinical, PRO

Translated by: Igor Koz

Efeitos de Upadacitinib nos Desfechos Reportados pelos Pacientes: Resultados de SELECT-BEYOND, um Estudo Clínico Randomizado de Fase 3 em Pacientes com Artrite Reumatoide e Resposta Inadequada a Drogas Antirreumáticas Modificadoras de Doença

Strand V, Schiff M, Tunida N, Friedman A, Meerwein S, Pangan A, Ganguli A, Fuldeore M, Song Y, Pope J.
Arthritis Res Ther . 2019 Dec 2;21(1):263. doi: 10.1186/s13075-019-2059-8.

In SELECT-BEYOND, UPA demonstrated clinically meaningful improvements in patient reported outcomes compared to PBO in patients with RA who had an inadequate response to bDMARDs. In this post-hoc analysis of the SELECT-BEYOND study, the effect of UPA 15 or 30 mg on patient reported outcomes were assessed and compared to PBO. Eligible patients (498) with an inadequate response to bDMARDs were randomly assigned 1:1:1 to receive UPA 15 mg, UPA 30 mg or PBO. PROs collected at Wk1, Wk4, and Wk12 inclu...

Keywords: JAK, Upadacitinib, Clinical, PRO

Translated by: Igor Koz

February 19

Tofacitinib em combinação com o metotrexato em pacientes com artrite reumatóide: eficácia clínica, resultados radiográficos e de segurança do estudo de verificação oral de Fase 3 de 24 meses

van der Heijde D, Strand V, Tanaka Y, Keystone E, Kremer J, Zerbini CAF, Cardiel MH, Stanley Cohen S, Nash P, Song YW, Tegzová D, Gruben D, Wallenstein G, Connell CA, Fleischmann R, ORAL Scan investigators.
Arthritis Rheumatol. 2019 Jun;71(6):878-891

RA patients receiving TOF 5 or 10 mg BID plus MTX showed sustained clinical and radiographic treatment effects through months 12-24. The safety profile was consistent with previous TOF studies. The 12-month data from the ORAL Scan study have been previously reported. This report assesses durability of responses, including structural damage progression, and safety with TOF through 24 months. Patients were randomized 4:4:1:1 to receive TOF 5 or 10 mg BID, or PBO advanced to TOF with stable, ba...

Keywords: JAK, Tofacitinib, Clinical, Safety