Publications

Filgotinib Demonstrates Efficacy in Rheumatoid Arthritis Independent of Smoking Status: Post Hoc Analysis of Phase 3 Trials and Claims-Based Analysis)

Rheumatol Ther 2023;11(1):177–189 doi 10.1007/s40744-023-00619-0

Curtis JR,

Emery P,

Downie B,

Zhong Y,

Liu J,

Han L,

Hawtin RE,

Burmester GR

This post hoc analysis by Curtis, et al. found that current and former smokers were more likely to switch from an anti-TNF bDMARD to a different bDMARD or JAK inhibitor in comparison to non-smokers. They also found that DAS28(CRP) ≤3.2 achievement was significantly higher after filgotinib therapy regardless of smoking status in MTX-IR, bDMARD-IR, and MTX-naïve patients.

Keywords:

• Adalimumab,
• Filgotinib,
• Phase 3,
• Efficacy

MACE and VTE across Upadacitinib Clinical Trial Programmes in Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

RMD Open 2023; 9(4):e003392 doi 10.1136/rmdopen-2023-003392

Charles-Schoeman C,

Choy E,

McInnes IB,

Mysler E,

Nash P,

Yamaoka K,

Lippe R,

Khan N,

Shmagel AK,

Palac H,

Suboticki J,

Curtis JR

Rates of MACE and VTE events in patients with RA or PsA treated are consistent across 15 mg and 30 mg doses of upadacitinib, and comparable with active comparators adalimumab and MTX. Several risk factors were also identified for MACE and VTE events in patients with RA.

Keywords:

• Baricitinib,
• Cardiovascular,
• JAK,
• MTX,
• Outcomes,
• Phase 3,
• Remission,
• Safety,
• Tofacitinib,
• Updacitinib

Safety profile of upadacitinib in patients at risk of cardiovascular disease: integrated post hoc analysis of the SELECT phase III rheumatoid arthritis clinical programme

Ann Rheum Dis. 2023 doi: 10.1136/ard-2023-223916

Fleischmann R,

Curtis JR,

Charles-Schoeman C,

Mysler E,

Yamaoka K,

Richez C,

Palac H,

Dilley D,

Liu J,

Strengholt S,

Burmester G

Pots hoc analysis of safety data in patients with RA at increased risk of CV events from the upadacitinib SELECT phase III RA clinical programme helps to contextualise the overall risk profile of upadacitinib.

Keywords:

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

Malignancy Risk with Tofacitinib versus TNF Inhibitors in Rheumatoid Arthritis: Results from the Open-Label, Randomised Controlled Oral Surveillance Trial

Ann Rheum Dis. 2023;82(3):331–343 doi: 10.1136/ard-2022-222543

Curtis JR,

Yamaoka K,

Chen YH,

Bhatt DL,

Gunay LM,

Sugiyama N,

Connell CA,

Wang C,

Wu J,

Menon S,

Vranic I,

Gómez-Reino JJ

Results from the open-label, randomised controlled ORAL Surveillance trial find increased risk of malignancies with tofacitinib versus TNFi, highlighting the highest incidence in patients with a history of atherosclerotic cardiovascular disease or increasing cardiovascular risk.

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Malignancy

The Effect of Guselkumab on General Health State in Biologic-Naïve Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial

Adv Ther. 2022 Oct;39(10):4632-4644 doi: 10.1007/s12325-022-02269-0

Curtis JR,

McInnes IB,

Rahman P,

Gladman DD,

Yang F,

Peterson S,

Agarwal P,

Kollmeier AP,

Hsia EC,

Han C,

Shiff NJ,

Shawi M,

Tillett W,

Mease PJ

In the latest study by Curtis, et al. guselkumab treatment regimens improved general HRQoL as measured by the EQ-5D-5L Index and EQ-VAS. In reaching this conclusion investigators aimed to determine the minimal important difference for both instruments and to understand the associations between patient-reported EQ-5D-5L Index and EQ-VAS scores as well as key PsA clinical features.

Keywords:

• IL-23,
• Guselkumab,
• Phase 3,
• PRO / QoL

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

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

Incidence and risk factors for herpes zoster in patients with rheumatoid arthritis receiving upadacitinib: a pooled analysis of six phase III clinical trials

Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-220822.

Winthrop KL,

Nash P,

Yamaoka K,

Mysler E,

Khan N,

Camp HS,

Song Y,

Suboticki JL,

Curtis JR

JAKinibs have been linked with an increased risk of HZ in patients with RA. To this end, Winthrop, et al. evaluated data from six Phase III clinical trials to determine the incidence of HZ in the upadacitinib (UPA)-treated patients with RA and identify potential risk factors for the development of HZ in these patients.Analysis of data provides further support for the need for continued vigilance and monitoring for signs of herpes zoster (HZ) in patients receiving UPA, particularly in Asian popul...

Keywords:

• JAK,
• Updacitinib,
• Phase 3,
• Safety,
• Meta analysis,
• Infections

Which Patient-reported Outcomes do Rheumatology Patients Find Important to Track Digitally? A Real-world Longitudinal Study in Arthritis Power

Arthritis Res Ther. 2021;23(1):53.

Nowell WB,

Gavigan K,

Kannowski CL,

Cai Z,

Hunter T,

Venkatachalam S,

Birt J,

Workman J,

Curtis JR

Fatigue, physical function, pain, and morning joint stiffness are the most important PROs to track, according to the rheumatology patients who experience these symptoms. Increasingly used, alongside clinical measures, to track symptoms and assess disease activity over time, patient-reported outcomes (PROs) are also important indicators of quality of life and treatment effectiveness. To enable us to better understand which PROs patients with rheumatic and musculoskeletal disease consider most imp...

Keywords:

• PRO / QoL,
• Real-World

Diminished cytokine-induced Jak/STAT signaling is associated with rheumatoid arthritis and disease activity

PLoS ONE 2021;16(1):e0244187

Ptacek J,

Hawtin RE,

Sun D,

Louie B,

Evensen E,

Mittleman BB,

Cesano A,

Cavet G,

Bingham CO III,

Cofield SS,

Curtis JR,

Danila MI,

Raman C,

Furie RA,

Genovese MC,

et al

This analysis provides evidence that immune cell signalling pathways are important in RA. There were consistent differences between RA patients and healthy controls in IFNα, IL-6, IL-10 and GM-CSF+ IL-2 induced JAK/STAT signalling in multiple immune cell subsets.We know that RA is characterised by dysregulation of immune responses, but the exact cause is unknown. Recently, single-cell transcriptomics and mass cytometry confirmed the critical role of activated immune cells and fibroblasts, increa...

Keywords:

• JAK,
• Basic Science