Publications

Effect of dose adjustments on the efficacy and safety of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of an open-label, long-term extension study (ORAL Sequel)

Clin Rheumatol. 2022 Jan 1. Epub ahead of print doi: 10.1007/s10067-021-05908-z

Mueller RB,

Schulze-Koops H,

Furst DE,

Cohen SB,

Kwok K,

Wang L,

Killeen T,

von Kempis J

Post-hoc analysis shows that dosing up from tofacitinib 5 to 10 mg BID is associated with improved efficacy for up to 12 months, versus staying on 5 mg BID, and dosing down from 10 to 5 mg BID is not generally associated with a significant loss of efficacy.Although clinical trials have generally shown no significant differences, in terms of efficacy and safety, when switching tofacitinib dose up or down, these per-protocol switches are not directly informative for clinical decision-making in dai...

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Efficacy,
• Dosing

Pain Reduction in Rheumatoid Arthritis Patients Who Use Opioids: A Post Hoc Analysis of Phase 3 Trials of Baricitinib

ACR Open Rheumatol. 2021. Epub ahead of print. doi: 10.1002/acr2.11380

Pope JE,

Lee YC,

Curtis JR,

Mo D,

Xie L,

Dickson CL,

Schlichting DE,

Cardoso A,

Simon LS,

Taylor PC

This post hoc analysis shows that pain reduction was similar between opioid users and nonusers with baricitinib 2 mg and 4 mg, but not adalimumab.Use of opioids to treat RA-related pain has increased, yet long-term use has been associated with reduced efficacy and safety concerns. In addition, the misuse of opioids has resulted in a public health crisis in the United States and highlights the need for safe, effective nonaddictive alternatives for pain management. As such, Pope, et al. assessed p...

Keywords:

• JAK,
• Baricitinib,
• Efficacy,
• Pain

Inhibition of structural joint damage progression with upadacitinib in rheumatoid arthritis: 1-year outcomes from the SELECT phase 3 program

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

Efficacy and safety of subcutaneous vedolizumab in patients with moderately to severely active crohn’s disease: Results from the VISIBLE 2 randomised trial

J Crohns Colitis. 2022 Jan 28;16(1):27-38 doi: 10.1093/ecco-jcc/jjab133

Vermeire S,

D'Haens G,

Baert F,

Danese S,

Kobayashi T,

Loftus EV,

Bhatia S,

Agboton C,

Rosario M,

Chen C,

Zhang W,

Kisfalvi K,

Sandborn WJ

The authors highlighted a significantly greater clinical remission rate at Week 52 for vedolizumab SC versus placebo in patients with moderately to severely active CD. This study aimed to report results from VISIBLE 2 which evaluated a new SC vedolizumab formulation as maintenance treatment in adults with moderately to severely active CD.

Keywords:

• Efficacy,
• Safety,
• PRO / QoL

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

Tofacitinib in juvenile idiopathic arthritis: a double-blind, placebo-controlled, withdrawal phase 3 randomised trial

Lancet. 2021;398(10315):1984–96

Ruperto N,

Brunner HI,

Synoverska O,

Ting TV,

Mendoza CA,

Spindler A,

et al.

Pivotal trial data show that tofacitinib is an effective treatment in patients with polyarticular course juvenile idiopathic arthritis (pJIA).New oral therapies are particularly relevant for children and adolescents, who might prefer to avoid injections. To this end, Ruperto, et al. assessed the efficacy and safety of tofacitinib versus placebo in patients with pJIA (N=225). They observed a JIA flare rate at Week 44 of 29% and 53% for tofacitinib and placebo, respectively. Safety results were si...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3

A review of JAK-STAT signalling in the pathogenesis of spondyloarthritis and the role of JAK inhibition

Rheumatology (Oxford). 2021. Epub ahead of print. doi: 10.1093/rheumatology/keab740.

McInnes IB,

Szekanecz Z,

McGonagle D,

Maksymowych WP,

Pfeil A,

Lippe R,

Song IH,

Lertratanakul A,

Sornasse T,

Biljan A,

Deodhar A

JAK inhibitors are likely to become an important part of the overall treatment paradigm for spondyloarthritis (SpA).Although not fully understood, the pathogenesis of SpA is complex and thought to involve both environmental and genetic factors that together elicit a chronic inflammatory response involving the innate and adaptive immune systems. Several different cytokines, TNF, IL-17A, IL-12/23 and IL-23, which are directly/indirectly affected by JAK molecules, are involved in the pathogenesis o...

Keywords:

• JAK,
• Basic Science,
• Review

Upadacitinib in patients with psoriatic arthritis and an inadequate response to non-biological therapy: 56-week data from the phase 3 SELECT-PsA 1 study

RMD Open. 2021;7(3):e001838

McInnes IB,

Kato K,

Magrey M,

Merola JF,

Kishimoto M,

Pacheco-Tena C,

Haaland D,

Chen L,

Duan Y,

Zueger P,

Liu J,

Lippe R,

Pangan AL,

Behrens F

Analysis of data over 56 weeks shows that efficacy responses are maintained with upadacitinib 15 mg and 30 mg.Following the publication of 12-week data from the Phase III, randomised double-blind, SELECT-PsA 1 study, earlier this year, McInnes, et al. now report the 56-week efficacy and safety data of upadacitinib 15 mg and 30 mg in patients with PsA and an inadequate response to non-biological therapyEfficacy responses and inhibition of radiographic progression were maintained with upadacitinib...

Keywords:

• JAK,
• Updacitinib,
• Phase 3

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