Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: Results from three Phase 3, multicentre, double-blind, randomised trials

Lancet 2022;399(10341):2113–28 doi: 10.1016/S0140-6736(22)00581-5

Danese S,

Vermeire S,

Zhou W,

Pangan AL,

Siffledeen J,

Greenbloom S,

Hébuterne X,

D'Haens G,

Nakase H,

Panés J,

Higgins PDR,

Juillerat P,

Lindsay JO,

Loftus EV Jr,

Sandborn WJ,

Reinisch W,

Chen MH,

Sanchez Gonzalez Y,

Huang B,

Xie W,

Liu J,

Weinreich MA,

Panaccione R

The results of two induction studies (UC1 and UC2) and a maintenance study (UC3) show upadacitinib superiority to placebo in treating ulcerative colitis (UC). Rates of clinical remission were significantly higher for all upadacitinib doses versus placebo in all three studies.

Keywords:

• Efficacy,
• GI,
• IL-6,
• Outcomes,
• Phase 3,
• Upadacitinib

Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications

Rheumatol Ther 2022 Jun;9(3):935-955. Doi: 10.1007/s40744-022-00434-z

Merola JF,

McInnes IB,

Deodhar AA,

Dey AK,

Adamstein NH,

Quebe-Fehling E,

Aassi M,

Peine M,

Mehta NN

Merola et al., reported the effect of interleukin (IL)-17A inhibition with secukinumab on cardiovascular (CV) risk parameters in patients with psoriasis, psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) over 1 year of treatment. This study evaluated data from 19 secukinumab related clinical trials in phase 3/4 in psoriasis, PsA, and axSpA.

Keywords:

• IL-17,
• Secukinumab,
• Basic Science,
• Biomarkers

The Impact of Tofacitinib on Fatigue, Sleep, and Health‑Related Quality of Life in Patients with Rheumatoid Arthritis: A Post Hoc Analysis of Data from Phase 3 Trials

Arthritis Res Ther. 2022;24(1):83 doi:10.1186/s13075-022-02724-x

Bartlett SJ,

Bingham CO,

van Vollenhoven R,

Murray C,

Gruben D,

Gold DA,

Cella D.

This was an exploratory post hoc analysis of pooled data, from over 2000 patients in three Phase 3 studies of tofacitinib, which demonstrates an association between tofacitinib treatment and significantly greater improvements in fatigue, sleep, and health-related quality of life (HRQoL), compared with placebo.

Keywords:

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

The effect of secukinumab on patient-reported outcomes in patients with active psoriatic arthritis in a randomised phase 3 trial

Lancet. 2022. Epub ahead of print

Strand V,

Kaeley GS,

Bergman MJ,

Gladman DD,

Coates LC,

Sherif B,

Hur P,

Parikh B,

Gilloteau I,

Mease PJ

Predefined analysis of FUTURE 5, the largest Phase 3 randomised trial of secukinumab in patients with PsA to date, demonstrates that secukinumab results in early, statistically significant, clinically meaningful, sustained improvements in PROs across all doses, compared with placebo.The fully human anti-interleukin 17A monoclonal antibody, secukinumab has shown clinical and radiographical efficacy in patients with PsA, yet the clinical significance of improvements across a wide variety of PROs r...

Keywords:

• IL-17,
• Secukinumab,
• PRO / QoL,
• Phase 3

Tofacitinib and risk of cardiovascular outcomes: results from the Safety of Tofacitinib in Routine care patients with Rheumatoid Arthritis (STAR-RA) study

Ann Rheum Dis. 2022 Jan 13. Epub ahead of print doi: 10.1136/annrheumdis-2021-221915

Khosrow-Khavar F,

Kim SC,

Lee H,

Lee SB,

Desai RJ

Real-world evidence finds no increased risk of CV outcomes with tofacitinib, in comparison with TNFi, in patients with RA. However, an elevated risk of CV outcomes cannot be ruled out in patients with CV risk factors or history of CVD.Recent post-marketing findings from the ‘ORAL Surveillance’ trial have raised concerns that tofacitinib, in comparison with TNFi, may increase the risk of CV disease in patients with RA who are at least 50 years of age and with at least one risk factor for CVD. To ...

Keywords:

• JAK,
• Tofacitinib,
• Real-World,
• Cardiovascular

Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment

Rheumatol Ther. 2021. Epub ahead of print. doi: 10.1007/s40744-021-00390-0

Winthrop KL,

Curtis JR,

Yamaoka K,

Lee EB,

Hirose T,

Rivas JL,

Kwok K,

Burmester GR

This post hoc analysis provides the first detailed description of the management and outcomes of HZ events in tofacitinib RA and PsA clinical studies.While prior studies have characterised the increased HZ risk with JAKinibs, the clinical management of these events has not been detailed.To this end, Winthrop, et al. analysed data from 21 RA and 3 PsA clinical studies to evaluate how HZ events and their sequelae were clinically managed during the RA and PsA tofacitinib clinical development progra...

Keywords:

• JAK,
• Tildrakizumab,
• Safety,
• Infections

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,
• Upadacitinib,
• Phase 3,
• Efficacy,
• Radiographic

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

Upadacitinib Monotherapy Improves Patient-Reported Outcomes in Rheumatoid Arthritis: Results From SELECT-EARLY and SELECT-MONOTHERAPY

Rheumatology (Oxford). 2021;60(7):3209–21

Strand V,

Tundia N,

Wells A,

Buch MH,

Radominski SC,

Camp HS,

Friedman A,

Suboticki JL,

Dunlap K,

Goldschmidt D,

Bergman M.

Upadacitinib treatment results in statistically significant and clinically meaningful improvements in health-related quality of life.Strand, et al. evaluated the effect of upadacitinib monotherapy versus methotrexate (MTX) on patient-reported outcomes (PRO) in MTX-naïve and MTX-inadequate responder patients with moderately-to-severely active RA. Their research from the SELECT-EARLY and SELECT-MONOTHERAPY randomised controlled trials found that upadacitinib monotherapy resulted in clinically mean...

Keywords:

• JAK,
• Upadacitinib,
• Phase 3,
• PRO / QoL

Associations of baseline use of biologic or targeted synthetic DMARDs with COVID-19 severity in rheumatoid arthritis: Results from the COVID-19 Global Rheumatology Alliance physician registry

Ann Rheum Dis. 2021 May 28. DOI: 10.1136/annrheumdis-2021-220418

Sparks JA,

Wallace ZS,

Seet AM,

Gianfrancesco MA,

Izadi Z,

Hyrich KL,

et al.

Results from the COVID-19 Global Rheumatology Alliance physician registry show that people with RA using rituximab or JAKi, at COVID-19 onset, are more likely to experience poor COVID-19 outcomes, ranging from hospitalisation to death, compared with use of TNFi.The ongoing COVID-19 pandemic has had a significant impact on people with RA, many of whom are treated with b/tsDMARDs. To help address some of the knowledge gaps around the influence of b/tsDMARDs on COVID-19 outcomes, Sparks, et al. ana...