Publications

Romatoid Artrit Hastalarında Selektif JAK-1 inhibitörü olan ABT-494 Faz 2b Çalışması

Arthritis Rheumatol 2016;68:2857–66

Genovese MC,

Smolen JS,

Weinblatt ME,

Burmester GR,

Meerwein S,

Camp HS,

Wang L,

Othman AA,

Khan N,

Pangan AL and Jungerwirth S

The summary and accompanying slide deck have been developed in conjunction with the Kremer et al. study (Study 2) which examined ABT-494 in TNF-IR patients in order to compare and contrast the data. In these two Phase 2b studies, ABT-494 (a novel selective JAK-1 inhibitor) was shown to be effective in patients with active RA who were non-responders to MTX or at least one TNF inhibitor.Patients with active RA who had an inadequate response to MTX (study 1) or were refractory to or intolerant of p...

Keywords:

• JAK,
• Upadacitinib,
• Phase 2

TNF İnhibitörlerine Yetersiz Yanıtlı veya İntolerans olan Aktif RA Hastalarında Sarilumab ve Biyolojik Olmayan Hastalık Modifıye Edici Antiromatizmal İlaçlar

Arthritis Rheumatol 2016. DOI:10.1002/art.39944.

Fleischmann R,

van Adelsberg J,

Lin Y,

da Rocha,

Castelar-Pinheiro G,

Brzezicki J,

Hrycaj P,

Graham NMH,

van Hoogstraten H,

Bauer D,

Burmester GR

In this Phase 3 study (TARGET) of TNF-IR patients, sarilumab plus csDMARD(s) demonstrated clinical efficacy and improvements in physical function versus placebo plus csDMARD(s).Patients (N=546) were randomised 1:1:1 to sarilumab 150 mg, 200 mg Q2W or placebo (all plus csDMARD[s]). Two co-primary endpoints versus placebo were investigated: ACR20 response rate at Week 24, and HAQ-DI change from baseline at Week 12.As well as improvements in ACR20 responses (33.7% vs 55.8 and 60.9%, for placebo, sa...

Keywords:

• IL-6,
• Sarilumab,
• Phase 3

Aktif Romatoid Artrit Hastalarında Sarilumab Monoterapisinin Adalimumab Monoterapisine Göre Etkinlik ve Güvenliğinin Değerlendirilmesi (MONARCH): Randomize, Çift-Kör, Paralel-Grup Faz III Çalışma

Ann Rheum Dis 2016. DOI 10.1136/annrheumdis-2016-210310

Burmester GR,

Lin Y,

Patel R,

van Adelsberg J,

Mangan EK,

Graham NMH,

van Hoogstraten H,

Bauer D,

Vargas JI,

Lee E-B

In this Phase 3 superiority study (MONARCH) of patients with active RA who should not continue treatment with MTX because of intolerance or inadequate response, sarilumab monotherapy demonstrated superior efficacy to adalimumab (ADA) monotherapy. Patients receiving sarilumab versus ADA also reported greater improvement in health status, including a trend towards greater improvement in fatigue.In this randomised, multicentre study, patients received sarilumab 200 mg Q2W plus placebo (n=184) or AD...

Keywords:

• IL-6,
• Sarilumab,
• Phase 3

Aktif romatoid artritli hastaların üçüncü-sıra tedavisinde metotreksat ile birlikte tofacitinib: Bir Faz 3 çalışmadan hastaların-bildirdiği sonuçlar

Arthritis Care Res (Hoboken). 2014 Sep 3. doi: 10.1002/acr.22453. [Epub ahead of print]

Strand V,

Burmester GR,

Zerbini CA,

Mebus CA,

Zwillich SH,

Gruben D,

Wallenstein GV

For many patients with rheumatoid arthritis, improvements in pain, physical function, fatigue, and health-related quality of life (HRQoL) are more important and meaningful than improvements in joint swelling, tenderness, or inhibition of structural damage. These patient-perceived benefits of RA therapy contribute importantly to overall clinical efficacy.

This paper presents patient-reported outcomes (PROs) form the ORAL Step trail, which assessed tofacitinib 5 mg or 10 mg twice daily, or ...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3

Romatoid artritte yeni hücreler ve sitokin hedefleri

Nat Rev Rheumatol. 2013. doi:10.1038/nrrheum.2013.168

Burmester GR,

Feist E,

Dörner T

Despite major progress in the treatment of RA over the past decade, sustained clinical remission remains elusive. The identification of new treatment targets is therefore necessary, with much research currently being undertaken in this area. Novel therapeutic approaches currently being investigated include T cell-directed therapies targeting both T cell activation and regulation; and the targeting of pathogenic B cell functions, including the use of depleting and non-depleting B cell-directed an...

Keywords:

• JAK,
• Review

Small molecules targeting JAKs—a new approach in the treatment of rheumatoid arthritis

Rheumatology 2013: doi: 10.1093/rheumatology/kes417

Feist E,

Burmester GR

This article focuses on the development of new small molecular inhibitors of Janus kinases (Jaks) in clinical trials for rheumatoid arthritis (RA). Of these, tofacitinib is at the most advanced stage of its clinical development and this article includes an overview of the results from the main tofacitinib clinical trials to date. These include the ORAL-Start study in methotrexate (MTX)-naïve patients; ORAL-Scan in inadequate responders to MTX; ORAL-Solo and ORAL-Sync in inadequate responders to ...

Keywords:

• JAK,
• Review

Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial

The Lancet 2013; 381(9865):451-60

Burmester GR,

Blanco R,

Charles-Schoeman C,

et al.

The ORAL Step trial is one of six studies conducted as part of the phase 3 research programme for the oral Janus kinase (JAK) inhibitor tofacitinib. This 6-month, double-blind, parallel-group phase 3 study investigated the efficacy and safety of tofacitinib in adults with moderate to severe rheumatoid arthritis (RA) with an inadequate response to tumour necrosis factor (TNF) inhibitors. Patients were randomised to 5 or 10 mg tofacitinib twice daily or placebo, which was switched to tofacitinib a...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3