Publications

Efficacy and safety of upadacitinib in patients with rheumatoid arthritis and inadequate response or intolerance to biological treatments: results through 5 years from the SELECT-BEYOND study

Journal Reference: RMD Open. 2024;10:e003918 doi: 10.1136/rmdopen-2023-003918

Fleischmann R,

Meerwein S,

Charles-Schoeman C,

Combe B,

Hall S,

Khan N,

Carter KM,

Camp HS,

Rubbert-Roth A

Fleischmann et al. evaluated the long-term efficacy and safety of upadacitinib in rheumatoid arthritis patients with inadequate response or intolerance to bDMARDs over five years. The study demonstrated that upadacitinib 15 mg and 30 mg were effective in maintaining disease control, with >75% of patients achieving CDAI LDA by week 260. The safety profile remained consistent with no new issues identified.

Keywords:

• Efficacy,
• LTE,
• Phase 3,
• Safety,
• Updacitinib

Two‑Year Imaging Outcomes from a Phase 3 Randomized Trial of Secukinumab in Patients with Non‑Radiographic Axial Spondyloarthritis

Arthritis Res Ther. 2023;16;25(1):80 doi 10.1186/s13075-023-03051-5

Braun J,

Blanco R,

Marzo-Ortega H,

Gensler L,

Van den Bosch F,

Hall S,

Kameda H,

Poddubnyy D,

van de Sande M,

van der Heide D,

Zhuang T,

Stefanska A,

Readie A,

Richards H,

Deodar A

Braun et al. studied a large cohort of patients with nr-axSpA, that demonstrated a secukinumab reduced SI joint inflammation (BME), this reduction was sustained over 104 weeks, from an overall low baseline level of spinal inflammation or structural damage.

Keywords:

• IL-17,
• Secukinumab,
• Imaging

Efficacité du certolizumab pegol chez les patients atteints de spondyloarthrite axiale non radiographique, stratifiée en fonction de l'IRM de la protéine C-reactive de départ : Analyse de l'étude C-axSpAnd

ACR Open Rheumatol. 2022 doi: 10.1002/acr2.11469

Robinson PC,

Maksymowych WP,

Gensler LS,

Hall S,

Rudwaleit M,

Hoepken B,

Bauer L,

Kumke T,

Kim M,

de Peyrecave N,

Deodhar A

The results of this analysis indicated that certolizumab pegol (CZP) treatment benefits patients with nr-axSpA across all the MRI/CRP subgroups studied. To reach this conclusion, this study evaluated clinical responses to CZP in patients with nr-axSpA stratified by baseline MRI/CRP status.

Inhibition de la progression des lésions articulaires structurelles avec l'upadacitinib dans la polyarthrite rhumatoïde : résultats à un an du programme de phase 3 SELECT

Rheumatology (Oxford). 2021. Epub ahead of print. doi: 10.1093/rheumatology/keab861

Peterfy CG,

Strand V,

Friedman A,

Hall S,

Mysler E,

Durez P,

Baraliakos X,

Enejosa JV,

Shaw T,

Li Y,

Chen S,

Song IH

.

Keywords:

• JAK,
• Updacitinib,
• Phase 3,
• Efficacy,
• Radiographic

Passage de l'Upadacitinib, un Inhibiteur de Janus Kinase, à l'Adalimumab Suite à une Réponse Insuffisante : Efficacité et Innocuité Chez les Patients Atteints de Polyarthrite Rhumatoïde

Ann Rheum Dis 2020; doi:10.1136/annrheumdis-2020-21841220

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

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 pati...

Keywords:

• JAK,
• TNF,
• Updacitinib,
• Adherence,
• Switching

Innocuité et efficacité de l'upadacitinib chez les patients atteints de polyarthrite rhumatoïde active réfractaires aux médicaments antirhumatismaux modifiants la maladie biologique (SELECT-BEYOND): essai de phase 3 à double insu, randomisé et contrôlé

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

Professor Iain McInnes Reviews the Most Important Papers from 2017

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

McInnes I

2017 was a successful year for rheumatoid arthritis research, with some key advances in JAK inhibitors and IL-6 inhibitors, as outlined below. - Tofacitinib was suggested as a potential treatment for psoriatic arthritis, and NICE recommended tofacitinib as a treatment for moderate to severe rheumatoid arthritis - Baricitinib studies supported the potential use of baricitinib as a treatment for rheumatoid arthritis - Filgotinib Phase 2 studies suggested that filgotinib could be effective a...

Keywords:

• Review

Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis

N Engl J Med 2017; 377:1537-50. DOI: 10.1056/NEJMoa1615975

Mease P,

Hall S,

FitzGerald O,

van der Heijde D,

Merola J F,

Avila-Zapata F,

Cieslak D,

Graham D,

Wang C,

Menon S,

Hendrikx T,

Kanik K S

In the Phase 3 OPAL Broaden trial of patients with active psoriatic arthritis (PsA) with inadequate response to ≥1 csDMARD, superior efficacy was observed in patients treated with tofacitinib (TOF) compared with those given placebo. Patients were randomised to: 5 mg TOF BID, 10 mg TOF BID, 40 mg adalimumab administered subcutaneously q2W, or placebo with a switch to 5 mg TOF at Month 3. Adalimumab was used as an active control in the study. A variety of primary and secondary endpoints were used ...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3

Efficacy and Safety of Tofacitinib Monotherapy, Tofacitinib with Methotrexate, and Adalimumab with Methotrexate in Patients with Rheumatoid Arthritis (ORAL Strategy): A Phase 3b/4, Double-Blind, Head-To-Head, Randomised Controlled Trial

Lancet. 2017 Jul 29;390(10093):457-468. doi: 10.1016/S0140-6736(17)31618-5

Fleischmann R,

Mysler E,

Hall S,

Kivitz A,

Moots R,

Luo Z,

DeMasi R,

Soma K,

Zhang R,

Takiya L,

Tatulych S,

Mojcik C,

Krishnaswami S,

Menon S,

Smolen J,

on behalf of the ORAL Strategy investigators

In this first head-to-head non-inferiority trial assessing a JAKi ± MTX directly compared with a TNFi + MTX in patients with RA, tofacitinib (TOF) + MTX showed non-inferiority to adalimumab (ADA) + MTX. Non-inferiority was not shown for TOF monotherapy versus TOF + MTX, or versus ADA + MTX.In this 52-week study, MTX-inadequate responder (IR) patients were randomised 1:1:1 to receive TOF 5 mg BID monotherapy, TOF 5 mg BID + MTX or ADA 40 mg every other week + MTX. The primary endpoint, ACR50 resp...

Keywords:

• JAK,
• Tofacitinib,
• Phase 4,
• Phase 3

Tofacitinib Versus Methotrexate In Rheumatoid Arthritis

N Engl J Med. 2014;370(25):2377–2386.

Lee EB,

Fleischmann R,

Hall S,

et al.

ORAL Start is the latest trial to be reported in the tofacitinib clinical development programme. It compares the use of tofacitinib monotherapy to MTX monotherapy, in RA patients who have had either no or a sub-therapeutic dose of MTX in the past. Nine hundred and fifty eight patients received either tofacitinib (5 mg or 10 mg) twice daily, or methotrexate at a dose that was incrementally increased to 20 mg per week over 8 weeks. The co primary efficacy endpoints were ACR 70 response, and mean c...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3