Publications

Pain and Inflammation as Mediators of Tofacitinib Treatment Effect on Fatigue in Patients with Ankylosing Spondylitis: A Mediation Analysis

Rheumatol Ther 2023;10(4):1073–1087 doi 10.1007/s40744-023-00570-0

Kristensen L,

Navarro-Compán V,

Magrey M,

Bushmakin A,

Cappelleri J,

Yndestad A,

Dina O,

Taylor P

Kristensen, et al. used mediation modelling to show that tofacitinib indirectly improved fatigue symptoms via back pain and morning stiffness. This study was carried out using FACIT-F- and BASDAI Q1-based models to determine the relationship between these variables.

Keywords:

• JAK,
• Tofacitinib,
• Efficacy,
• Pain

Baricitinib Safety for Events of Special Interest in Populations at Risk: Analysis from Randomised Trial Data Across Rheumatologic and Dermatologic Indications

Adv Ther. 2023;40(4):1867–1883 doi: 10.1007/s12325-023-02445-w

Taylor PC,

Bieber T,

Alten R,

Witte T,

Galloway J,

Deberdt W,

Issa M,

Haladyj E,

De La Torre I,

Grond S,

Wollenberg A

Analysis of pooled data from the baricitinib clinical development programmes finds a low incidence rate of MACE, myocardial infarction, lung cancer, VTE, and overall mortality in patients <65 years without risk factors.

Keywords:

• JAK,
• Baricitinib,
• Safety,
• Review

Impact of initial therapy with upadacitinib or adalimumab on achievement of 48-week treatment goals in patients with rheumatoid arthritis: post hoc analysis of SELECT-COMPARE

Rheumatology (Oxford). 2022. Epub ahead of print doi: 10.1093/rheumatology/keac477

Mysler E,

Tanaka Y,

Kavanaugh A,

Aletaha D,

Taylor PC,

Song IH,

Shaw T,

Song Y,

DeMasi R,

Ali M,

Fleischmann R

Post hoc analysis findings provide the first data evaluating the importance of treatment order with JAKinib vs TNFi as initial therapy, suggesting that a JAKinib first strategy leads to more rapid improvements in treatment outcomes following csDMARD failure.

Keywords:

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

Achieving pain control in early rheumatoid arthritis with baricitinib monotherapy or in combination with methotrexate versus methotrexate monotherapy

RMD Open. 2022;8(1):e001994 doi: 10.1136/rmdopen-2021-001994

Taylor PC,

Alten R,

Álvaro Gracia JM,

Kaneko Y,

Walls C,

Quebe A,

Jia B,

Bello N,

Terres JR,

Fleischmann R

Post hoc analysis of the RA-BEGIN trial finds that, over a one-year period, patients treated with baricitinib (monotherapy or in combination with methotrexate [MTX]) report greater pain relief and a more rapid attainment of clinically meaningful thresholds of pain improvement, than patients who receive MTX monotherapy.Often overlooked, when treating RA solely to a disease activity target, patient-reported pain is common in RA, even in those reaching inflammatory remission. The fact that pain per...

Keywords:

• JAK,
• Baricitinib,
• Efficacy,
• Pain

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

Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database

Ann Rheum Dis. 2021. Epub ahead of print. doi: 10.1136/annrheumdis-2021-221276.

Taylor PC,

Takeuchi T,

Burmester GR,

Durez P,

Smolen JS,

Deberdt W,

Issa M,

Terres JR,

Bello N,

Winthrop KL

Analysis of data from the highest level of patient exposure to baricitinib across the spectrum of the RA population demonstrates that baricitinib maintained a similar safety profile to earlier analyses, with no new safety signals identified.Using integrated data from nine randomised controlled trials, Taylor, et al. assessed the safety of baricitinib 2 mg and 4 mg once-daily. Analysis of data from 3770 patients (median 4.6 years, up to 9.3 years) with active RA showed that baricitinib maintained...

Keywords:

• JAK,
• Baricitinib,
• Safety,
• LTE

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

Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis with 3 years of treatment: results from a long-term study

Rheumatology (Oxford). 2021;60(5):2256-2266.

Smolen JS,

Xie L,

Jia B,

Taylor PC,

Burmester G,

Tanaka Y,

Elias A,

Cardoso A,

Ortmann R,

Walls C,

Dougados M.

Baricitinib 4mg may be considered for long-term treatment of early and refractory rheumatoid arthritis following results demonstrating efficacy and tolerability for up to 3 years.Smolen JS, et al. analysed data from two completed 52-week, phase III studies, RA-BEGIN (DMARD-naïve) and RA-BEAM (MTX-IR), and one ongoing long-term extension study (RA-BEYOND) – providing data for 148 weeks in total. Results demonstrated that the long-term maintenance of clinically relevant treatment goals, including ...

Keywords:

• JAK,
• Baricitinib,
• LTE,
• Efficacy

The JAK/STAT Pathway: A Focus on Pain in Rheumatoid Arthritis

Semin Arthritis Rheum. 2021 Feb;51(1):278-284

Simon LS,

Taylor PC,

Choy EH,

Sebba A,

Quebe A,

Knopp KL,

Porreca F

Many cytokines associated with RA pathogenesis and pain are affected directly or indirectly by the JAK/STAT pathway, therapeutic targeting may offer promise. Having better understanding of these mechanisms can help clinicians make treatment decisions that optimise the control of inflammation and pain. However, pain in patients with RA is complex and involves multiple driving mechanisms that may differentially occur over time in different people. Although one known constant is that nociceptive ac...

Keywords:

• JAK,
• Basic Science,
• Review

Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis with 3 years of treatment: results from a long-term study

Rheumatology 2020; doi:10.1093/rheumatology/keaa576

Smolen JS,

Xie L,

Jia B,

Taylor PC,

Burmester G,

Tanaka Y,

Elias A,

Cardoso A,

Ortmann R,

Walls C,

Dougados M

Three year follow up data for baricitinib demonstrated efficacy in populations that span the clinical disease continuum in RA, including DMARD-naïve, MTX-IR, csDMARD-IR, and bDMARD-IR and was well tolerated. This study evaluated achievement and maintenance of LDA, remission and physical functioning in patients treated with baricitinib for up to 3 years. Data were analysed from two 52-week, Phase 3 studies (RA-BEAM and RA-BEGIN), and one ongoing long-term extension (RA-BEYOND). Patients completin...

Keywords:

• JAK,
• Baricitinib,
• LTE,
• Efficacy