Publications

Safety Profile of Upadacitinib up to 3 Years in Psoriatic Arthritis: An Integrated Analysis of Two Pivotal Phase 3 Trials

Rheumatol Ther. 2022 doi: 10.1007/s40744-021-00410-z

Burmester G,

Winthrop K,

Blanco R,

Nash P,

Goupille P,

Azevedo V,

Salvarani C,

Rubbert-Roth A,

Lesser E,

Lippe R,

Lertratanakul A,

Mccaskill RM,

Liu J,

Ruderman EM

Upadacitinib 15 mg once daily demonstrated a similar safety profile to adalimumab 40 mg every other week, except for higher rates of HZ and opportunistic infections with upadacitinib treatment in patients treated for PsA

Keywords:

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

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

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

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 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

Median Time to Pain Improvement and the Impact of Baseline Pain Severity on Pain Response in Patients with Psoriatic Arthritis Treated with Tofacitinib

RMD Open. 2021;7(2):e001609.

de Vlam K,

Ogdie A,

Bushmakin AG,

Cappelleri JC,

Fleischmann R,

Taylor PC,

Azevedo V,

Fallon L,

Woolcott J,

Mease PJ.

Tofacitinib 5 mg twice daily provides clinically meaningful improvements in pain for patients with PsA.Reducing pain is a primary treatment concern for patients with PsA. As such, de Vlam, et al. set out to evaluate the time to pain improvement and the impact of baseline pain severity on pain response in patients with PsA receiving tofacitinib.Using data from the OPAL Broaden and OPAL Beyond trials, they discovered that clinically important improvements in pain were experienced by more patients,...

Keywords:

• JAK,
• Tofacitinib,
• PRO / QoL,
• Pain

Upadacitinib in Patients with Psoriatic Arthritis and Inadequate Response to Biologics: 56-Week Data from the Randomized Controlled Phase 3 SELECT-PsA 2 Study

Rheumatol Ther. 2021;8(2):903–919

Mease PJ,

Lertratanakul A,

Papp KA,

van den Bosch FE,

Tsuji S,

Dokoupilova E,

Keiserman MW,

Bu X,

Chen L,

McCaskill RM,

Zueger P,

McDearmon-Blondell EL,

Pangan AL,

Tillett W.

Fifty-six-week data suggest that upadacitinib could be a favourable long-term treatment option in patients with PsA who are refractory to biologic therapy.As the need for additional therapeutic agents that can effectively control disease activity continues, new data from a 56-week analysis of the oral reversible JAK1 inhibitor, upadacitinib, currently under investigation for the treatment of PsA, shows that efficacy of the drug is maintained over the duration of this study.Mease, et al. explored...

Keywords:

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

JAK/STAT pathway and nociceptive cytokine signalling in rheumatoid arthritis and psoriatic arthritis

Clin Exp Rheumatol. 2021;39(3):668-675.

Crispino N,

Ciccia F.

The JAK/STAT pathway is receiving increasing attention in modulation of nociceptive responses, given its clear role in cytokine signalling. The authors of this review speculate that JAKinibs may have an effect on the modulation of nociception and reduction of pain.Crispino N, et al. review the impact of pain in patients with rheumatic disease and the physiological basis of modulating nociceptive pain. They examine the role of cytokines in the modulation of pain and analyse current clinical JAKin...

Keywords:

• JAK,
• Basic Science,
• MOA

Comparative efficacy and safety of secukinumab, ixekizumab, and tofacitinib in patients with active psoriatic arthritis showing insufficient response to tumor necrosis factor inhibitors

Int J Clin Pharmacol Ther. 2021. Epub ahead of print.

Song GG,

Lee YH.

Bayesian network meta-analysis of randomised controlled trials (RCTs) highlights the effectiveness of secukinumab, ixekizumab, and tofacitinib in patients with psoriatic arthritis (PsA) and an inadequate response to tumour necrosis factor inhibitors (TNFi).There is a current need for therapies with alternative mechanisms of actions to DMARDs and TNFi, for the significant proportion of patients with PsA who insufficiently respond to these therapies. While RCTs for therapies such as secukinumab a...

Keywords:

• JAK,
• IL-17,
• Secukinumab,
• Tofacitinib,
• Efficacy,
• Safety

Trial of Upadacitinib and Adalimumab for Psoriatic Arthritis

N Engl J Med. 2021;384(13):1227-1239.

McInnes IB,

Anderson JK,

Magrey M,

Merola JF,

Liu Y,

Kishimoto M,

Jeka S,

Pacheco- Tena C,

Wang X,

Chen L,

Zueger P,

Liu J,

Pangan AL,

Behrens F.

Upadacitinib efficacy proves to be greater than placebo, and non-inferior to adalimumab, in treating patients with psoriatic arthritis (PsA). Already approved for the treatment of rheumatoid arthritis, McInnes, et al. studied oral upadacitinib at a dose of 15 mg or 30 mg, alongside placebo or adalimumab, in this 24-week, Phase III trial, in over 1700 patients with PsA. At the primary endpoint (Week 12), ACR20 response was greater with upadacitinib than placebo, and non-inferior to adalimumab; wi...

Keywords:

• JAK,
• Updacitinib,
• Review