Publications

Professor Iain McInnes Reviews the Most Notable Papers from 2018

Please click the links below to go to the CSF review of each paper

McInnes. I

2018 brought a wealth of new data in cytokine signalling and IL-6 that helps inform current clinical practice and brings the promise of new options in the future. There was good data on the use of sub cutaneous tocilizumab as well as strategies in early RA and for methotrexate tapering. For the currently marketed JAK inhibitors, tofacitinib and baricitinib, continuous long-term efficacy and safety data further support its current use and applications. On the development side, the outcomes of the...

Keywords:

• Review

Safety and Efficacy of Upadacitinib in Patients with Active Rheumatoid Arthritis Refractory To Biologic Disease-Modifying Anti-Rheumatic Drugs (SELECT-BEYOND): a Double-Blind, Randomised Controlled Phase 3 Trial

Lancet 2018;391:2513–24

Genovese MC,

Fleischmann R,

Combe B,

Hall S,

Rubbert-Roth A,

Zhang Y,

Zhou Y,

Mohamed M-EF,

Meerwein S,

Pangan AL

Upadacitinib (UPA) extended release formulation was effective in treating patients with moderate-to-severe RA with an inadequate response to bDMARDs.Phase 2 study data has shown that UPA is an efficacious and safe treatment for active RA.1,2 SELECT-BEYOND was a double-blind, long-term extension, Phase 3 study to assess the efficacy of UPA in patients with RA who were bDMARD-IR. The first 12-weeks of SELECT-BEYOND were placebo-controlled, with a double-blind period followed by an ongoing double-b...

Keywords:

• JAK,
• Updacitinib,
• Phase 3

Long-term Radiographic and Patient-reported Outcomes in Patients with Rheumatoid Arthritis Treated with Tofacitinib: ORAL Start and ORAL Scan Post-hoc Analyses

Rheumatol Ther. 2018 Dec;5(2):341-353. doi: 10.1007/s40744-018-0113-7

Strand V,

Kavanaugh A,

Kivitz AJ,

van der Heijde D,

Kwok K,

Akylbekova E,

Soonasra A,

Snyder M,

Connell C,

Bananis E,

Smolen JS

Tofacitinib (TOF) therapy reduced the progression of structural joint damage at 2 years, in patients of all disease states, compared with patients given methotrexate (MTX). Early intervention with DMARDs aim to prevent the development of future RA symptoms and inhibit the progression of structural damage to the joints. This post-hoc analysis uses data from two Phase 3 TOF studies, to examine the efficacy of early intervention with TOF on long-term radiographic outcomes and disease activity state...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• PRO / QoL,
• Radiographic

Effect of Filgotinib, a Selective JAK1 Inhibitor, with or without Methotrexate in Patients with Rheumatoid Arthritis: Patient-Reported Outcomes

Arthritis Res Ther 2018; 20(1):57 doi: 10.1186/s13075-018-1541-z

Genovese MC,

Westhovens R,

Meuleners L,

van der Aa A,

Harrison P,

Tasset C,

Kavanaugh A

Patient-reported outcomes (PROs) from two, Phase 2b, filgotinib (FIL) studies, DARWIN 1 and 2, revealed that patients receiving FIL had improved and sustained PRO responses compared with placebo. With suboptimal RA treatment, patients lose joint functional ability, which heavily influences patient quality of life. The previously reported data from the DARWIN studies, concluded that patients given FIL achieved clinically relevant dose-dependent improvements compared with patients given placebo¹,²...

Keywords:

• JAK,
• Filgotinib,
• PRO / QoL

Tofacitinib with Conventional Synthetic Disease-modifying Antirheumatic Drugs in Chinese Patients with Rheumatoid Arthritis: Patient-reported Outcomes from a Phase 3 Randomised Controlled Trial

Int J Rheum Dis 2018; 21(2):402–14

Li Z,

An Y,

Su H,

Li H,

Xu J,

Zheng Y,

Li G,

Kwok K,

Wang L,

Wu Q

This Chinese sub-population of patients with RA from ORAL Sync reported significant improvements in patient-reported outcomes (PROs), which were maintained up to 12 months from tofacitinib (TOF) treatment initiation. ORAL Sync was a randomised, Phase 3 study investigating TOF therapy in combination with csDMARDs in patients with active RA who had previously had an inadequate response to csDMARDs. To date, this is the only Phase 3 study of TOF in patients from China with RA. This analysis include...

Keywords:

• JAK,
• Phase 3

Patient-Reported Outcomes in Newly Diagnosed Early Rheumatoid Arthritis Patients Treated to Target with a Tocilizumab- or Methotrexate-based Strategy

Rheumatology (Oxford) 2017 Dec 1;56(12):2179-2189 doi: 10.1093/rheumatology/kex319

Teitsma XM,

Jacobs JWG,

Welsing PMJ,

Pethö-Schramm A,

Borm MEA,

Hendriks L,

Denissen NHAM,

van Laar JM,

Lafeber FPJG,

Bijlsma JWJ

Patient-reported outcomes (PROs) vastly improved in the first 24 weeks post-initiation of tocilizumab (TCZ) therapies compared to methotrexate (MTX) monotherapy in the U-Act-Early trial.U-Act-Early was a two-year, treat-to-target study that compared the safety and efficacy of TCZ and MTX treatment strategies in DMARD-naïve patients with early RA. Sustained remission was classed as more effective in patients given TCZ monotherapy or combination therapy with MTX compared to MTX alone. TCZ therapie...