Publications

Efficacy and Safety of Upadacitinib for Active Ankylosing Spondylitis Refractory to Biological Therapy: A Double-blind, Randomised, Placebo-controlled Phase 3 Trial

Ann Rheum Dis 2022 doi:10.1136/annrheumdis-2022-222608

van der Heijde D,

Baralikos X,

Sieper J,

Deodhar A,

Inman RD,

Kameda H,

Zend X,

Si Y,

Bu X,

Pangan AL,

Wung P,

Song I

Van der Heijde et al., carried out a study to show whether upadacitinib offers an effective treatment option for bDMARD-naïve and bDMARD-IR patients with active AS. Their results indicated that upadacitinib 15 mg significantly improved the signs and symptoms of active AS. The treatment was well tolerated for 14 weeks in bDMARD-IR patients, consistent with results observed in the upadacitinib AS bDMARD-naïve study.

Keywords:

• JAK,
• Updacitinib,
• Efficacy,
• Safety,
• Phase 3

Efficacy and Safety of Selective TYK2 Inhibitor, Deucravacitinib, in a Phase II Trial in Psoriatic Arthritis

Ann Rheum Dis. 2022 doi: 10.1136/annrheumdis-2021-221664

Mease PJ,

Deodhar AA,

van der Heijde D,

Behrens F,

Kivitz AJ,

Neal J,

Kim J,

Singhal S,

Nowak M,

Banerjee S

In this study Mease, et al. aimed to evaluate the efficacy and safety of deucravacitinib in patients with active PsA. Treatment with the selective TYK2i deucravacitinib was well tolerated and resulted in greater improvements than placebo in ACR-20 as well as Multiplicity-controlled secondary endpoints and other exploratory efficacy measures in patients.

Keywords:

• TYK2,
• Deucravacitinib,
• Phase 2,
• Efficacy,
• Safety

Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study

Ann Rheum Dis. 2021 Apr 27;80(8):1004–13.

Deodhar A,

Sliwinska-Stanczyk P,

Xu H,

Baraliakos X,

Gensler LS,

Fleishaker D,

Wang L,

Wu J,

Menon S,

Wang C,

Dina O,

Fallon L,

Kanik KS,

van der Heijde D.

A Phase 3 study assesses the efficacy and safety of tofacitinib in adults with active AS.Deodhar, et al. found that ASAS20 and ASAS40 response rate significantly increased with tofacitinib 5 mg BID versus placebo at Week 16, with improvements maintained to Week 48.There were no new safety signals detected over the course of the study....

Keywords:

• JAK,
• Tofacitinib,
• Phase 3

Highlights of 2021

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

McInnes IB

I’m sure we’d all hoped that this year would be a return to normal but, in the midst of the challenges we’ve faced with COVID-19, the rheumatology community has continued to deliver excellent publications, and we’ve covered many of these on the CSF. Here are my highlights from 2021's publications: Points to Consider for the Treatment of Immune-Mediated Inflammatory Diseases With Janus Kinase Inhibitors: A Co...

Keywords:

• Review

Radiographic progression of structural joint damage over 5 years of baricitinib treatment in patients with rheumatoid arthritis: Results from RA-BEYOND

J Rheumatol. 2021 Sep 15:jrheum.210346.

van der Heijde D,

Kartman CE,

Xie L,

Beattie S,

Schlichting D,

Mo D,

Durez P,

Tanaka Y,

Fleischmann R.

Oral baricitinib maintained lower levels of radiographic progression than initial csDMARD or placebo through 5 years in patients with active RA.It is well known that persistent joint inflammation in RA can lead to irreversible structural damage that impacts on patient physical function and quality-of-life. To this end, van der Heijde, et al. evaluated the effect of baricitinib on inhibiting radiographic progression of structural joint damage over 5 years in patients with active RA. Results from ...

Keywords:

• JAK,
• Baricitinib,
• LTE,
• Efficacy,
• Radiographic

Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies

Rheumatology (Oxford). 2021;60(4):1708-1716.

van der Heijde D,

Landewé RBM,

Wollenhaupt J,

Strengholt S,

Terry K,

Kwok K,

Wang L,

Cohen S.

Long-term evaluation of tofacitinib has found limited progression of structural damage in patients with RA treated with tofacitinib for up to 5 years. Similar results were also observed for patients receiving tofacitinib monotherapy or combination therapy for up to 3 years.It is well known that inflammation in RA leads to structural damage over time, and therapies such as DMARDS have the ability to reduce inflammation whilst inhibiting the progression of structural damage. In this study, van der...

Keywords:

• JAK,
• Tofacitinib,
• LTE,
• Radiographic

Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial

Ann Rheum Dis. 2021 Jan 15:annrheumdis-2020-219213.

Westhovens R,

Rigby WF,

van der Heijde D,

Ching DW,

Stohl W,

Kay J,

Chopra A,

Bartok B,

Matzkies F,

Yin Z,

Guo Y,

Tasset C,

Sundy JS,

Jahreis A,

Mozaffarian N,

Messina OD,

Landewé R BM,

Atsumi T,

Burmester GR

Filgotinib doses in combination with MTX have shown improved signs, symptoms and physical function in patients with RA and limited or no prior MTX exposure. FIL 200mg monotherapy did not have a superior ACR20 response rate versus MTX. This 52-week, phase 3 study evaluated FIL in 1252 patients with RA. Patients were randomised to FIL 200mg + MTX or FIL 100mg + MTX, FIL 200 mg monotherapy, or MTX monotherapy. The primary endpoint was the proportion patients achieving ACR20 at week 24. Safety was e...

Keywords:

• JAK,
• Fenebrutinib,
• Phase 3

Filgotinib Versus Placebo or Adalimumab in Patients with Rheumatoid Arthritis and Inadequate Response to Methotrexate: A Phase III Randomised Clinical Trial

Ann Rheum Dis. 2021 Jan 27:annrheumdis-2020-219214

Combe B,

Kivitz A,

Tanaka Y,

van der Heijde D,

Simon JA,

Baraf HSB,

Kumar U,

Matzkies F,

Bartok B,

Ye L,

Guo Y,

Tasset C,

Sundy JS,

Jahreis A,

Genovese MC,

Mozaffarian M,

Landewé RBM,

Bae S-C,

Keystone EC,

Nash P

Filgotinib improved RA signs and symptoms, physical function, and inhibited radiographic progression. FIL 200mg plus MTX, but not FIL 100mg plus MTX showed non-inferiority to ADA plus MTX, based on DAS28(CRP) low disease activity. FIL was also well tolerated in RA patients with inadequate response to MTX.This 52-week, phase 3 randomised clinical trial (FINCH 1) evaluated the efficacy and safety of FIL in patients with RA randomised to FIL 200 or 100mg, ADA 40mg, or placebo, all with background M...

Keywords:

• JAK,
• Fenebrutinib,
• Phase 3

Points to Consider for the Treatment of Immune-Mediated Inflammatory Diseases With Janus Kinase Inhibitors: A Consensus Statement

2021 Jan;80(1):71-87. doi: 10.1136/annrheumdis-2020-218398. Epub 2020 Nov 6.

Nash P,

Kerschbaumer A,

Dorner T,

Dougados M,

Fleischmann RM,

Geissler K,

McInnes I,

Pope JE,

van der Heijde D,

Stoffer-Marx M,

Takeuchi T,

Trauner M,

Winthrop KL,

de Wit M,

Aletaha D,

Baraliakos X,

Boehncke W-H,

Emery P,

Isaacs JD,

Kremer J,

Lee EB,

et al

JAKi are approved in various immune-mediated inflammatory diseases. With five JAKi now licensed, this paper reviews key points to consider in their use to assist clinicians, patients, and other stakeholders once the decision is made to commence JAKi.The consensus was developed by a Steering Committee and an expanded Task Force using EULAR standard operating procedures. The committee included patients as well as experts in rheumatology, gastroenterology, haematology, dermatology, and infectious d...

Keywords:

• JAK,
• Review

Points to consider for the treatment of immune-mediated inflammatory diseases with Janus kinase inhibitors: a systematic literature research

RMD Open 2020;6:e001374 doi:10.1136/rmdopen-2020-001374

Kerschbaumer A,

Smolen JS,

Nash P,

Doerner T,

Dougados M,

Fleischmann R,

Geissler K,

McInnes IM,

Takeuchi T,

Trauner M,

Winthrop K,

de Wit M,

Boehncke W-H,

Falzon L,

van der Heijde D

Trials of JAKi have been conducted in many therapy areas, including rheumatology, dermatology and gastroenterology. In 2019, a task force was set up to create a consensus to guide clinicians on how to use JAKi in clinical practice. This systematic literature review conducted in 2019 support this consensusIn line with EULAR’s standardised operating procedures for recommendations, a literature search was conducted in EMBASE, Medline and the Cochrane Library databases. To evaluate the efficacy of t...

Keywords:

• JAK,
• Review