Publications

Tofacitinib Efficacy and Safety in Patients With Ankylosing Spondylitis by Prior Biologic Disease-Modifying Antirheumatic Drug Use: A Post Hoc Analysis

ACR Open Rheumatol. 2023;5(12)632–643 doi 10.1002/acr2.11601

Deodhar A,

Marzo-Ortega H,

Wu J,

Wang C,

Dina O,

Kanik KS,

Fallon L,

Gensler LS

In this post hoc analysis by Deoodhar, et al., the authors found that tofacitinib demonstrated greater efficacy than placebo in bDMARD-naïve and TNFi-IR AS patients. They also found that safety event rates for tofacitinib therapy were numerically higher in the TNFi-IR subgroup than the bDMARD-naïve subgroup.

Keywords:

• Tofacitinib,
• Safety

Post-Marketing Safety Surveillance of Tofacitinib over 9 Years in Patients with Psoriatic Arthritis and Rheumatoid Arthritis

Rheumatol Ther. 2023;10(5):1255–1276 doi: 10.1007/s40744-023-00576-8

Burmester GR,

Coates LC,

Cohen SB,

Tanaka Y,

Vranic I,

Nagy E,

Lazariciu I,

Chen AS,

Kwok K,

Fallon L,

Kinch C

The data gathered in this post-marketing surveillance study aligned with the previously established safety profile of tofacitinib, and reports were found to have consistent safety profiles in the treatment of both patient with PsA and RA. However, the results of this study should be interpreted considering the limitations of post-marketing surveillance studies.

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Real-World

Tofacitinib Reduce la Inflamación Espinal en Cuerpos Vertebrales y Elementos Posterolaterales en la Espondilitis Anquilosante: Resultados de un ensayo de fase 2

Rheumatol Ther. 2023;10(4):1001–1020 doi 10.1007/s40744-023-00564-y

Østergaard M,

Wu J,

Fallon L,

Sherlock SP,

Wang C,

Fleishaker D,

Kanik KS,

Maksymowych WP

Tofacitinib treatment is associated with a significant improvement in CANDEN MRI scores of spinal inflammation in axSpA patients. This study by Østergaard, et al. also validates the CANDEN MRI scoring system as an approach for measuring axSpA-associated inflammatory lesions.

Keywords:

• JAK,
• Tofacitinib,
• Efficacy,
• Phase 2,
• Imaging

Asociaciones entre el Riesgo Cardiovascular y las Tasas de Incidencia de Eventos Cardiovasculares Mayores y Malignidades en Pacientes con Artritis Psoriásica y Psoriasis Recibiendo Tofacitinib

Ther Adv Musculoskelet Dis. 2023 doi: 10.1177/1759720X221149965

Kristensen LE,

Strober B,

Poddubnyy D,

Leung YY,

Jo H,

Kwok K,

Vranic I,

Fleishaker DL,

Fallon L,

Yndestad A,

Gladman DD

Baseline 10-year atherosclerotic cardiovascular disease risk and metabolic syndrome are potentially associated with the incidence of both MACE and malignancies in patients receiving TOFA in the PsA and PsO clinical trial programs. This post hoc analysis aimed to examine the baseline CV disease risk and its association with the occurrence of MACE and malignancies in TOFA-treated patients with PsA and PsO.

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Cardiovascular

Effect of Tofacitinib on Pain, Fatigue, Health-related Quality of Life and Work Productivity in Patients with Active Ankylosing Spondylitis: Results from A Phase III, Randomised, Double-blind, Placebo-controlled Trial

RMD Open 2022 doi:10.1136/rmdopen-2022-002253

Navarro-Compán V,

Wei JC-C,

Van den Bosch F,

Magrey M,

Wang L,

Fleishaker D,

Cappelleri JC,

Wang C,

Wu J,

Dina O,

Fallon L,

Strand V

Navarro-Compán et al, determined the effectiveness of tofacitinib in patients with active ankylosing spondylitis in a Phase III, randomised, double-blind, placebo-controlled trial.

Keywords:

• JAK,
• Tofacitinib,
• Phase 3,
• 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

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

Incidencia de Eventos Tromboembólicos Arteriales y Venosos Reportados en Los Programas de Desarrollo de Tofacitinib en Artritis Reumatoide, Psoriasis y Artritis Psoriásica y de Datos de Mundo Real

Annals of the Rheumatic Diseases 05 August 2020 2020 Nov;79(11):1400-1413. doi: 10.1136/annrheumdis-2019-216761. Epub 2020 Aug 5.

Mease P,

Charles-Schoeman C,

Cohen S,

Fallon L,

Woolcott J,

Yun H,

Kremer J,

Greenberg J,

Malley W,

Onofrei A,

Kanik KS,

Graham D,

Wang C,

Connell C,

Valdez H,

Hauben M,

Hung E,

Madsen A,

Jones TV,

Curtis JR

Concerns surrounding increased rates of PE and cardiovascular associated deaths has led to black box warnings when prescribing JAK inhibitors. As such, ongoing investigations regarding cardiovascular and VTE event risks in JAK inhibitor therapies, both clinical and real-world, are vital. Mease and colleagues consider data from clinical tofacitinib development programmes, and the ongoing real-data study A3921133. Conclusions from data analysis state that those with pre-existing cardiovascular and...

Keywords:

• JAK,
• Tofacitinib,
• Safety

Seguridad y Eficacia de Tofacitinib en Pacientes con Artritis Psoriásica Activa: Análisis Provisional de OPAL Balance, un Estudio Abierto de Extensión a Largo Plazo

Rheumatol Ther 2020 doi.org/10.1007/s40744-020-00209-4

Nash P,

Coates LC,

Kivitz AJ,

Mease PJ,

Gladman DD,

Covarrubias-Cobos JA,

FitzGerald O,

Fleishaker D,

Wang C,

Wu J,

Hsu M,

Menon S,

Fallon L,

Romero AB,

Kanik KS

This 3-year, open-label, LTE study follows PsA patients previously treated in pivotal studies OPAL Broaden and OPAL Beyond. It demonstrates maintained safety and efficacy of tofacitinib up to 36 and 30 months, respectively. No new safety concerns are highlighted. Previous P3 studies, OPAL Broaden and OPAL Beyond, demonstrated safety and efficacy of 5mg and 10mg tofacitinib BID in PsA. These patients rolled over to OPAL Balance for a period of 36 months. 686 participants were used in this interim...

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Efficacy,
• LTE

Tofacitinib en Artritis Reumatoide: Falta de Cambio Temprano en Actividad de la Enfermedad Predice una Baja Probabilidad de Lograr Baja Actividad de la Enfermedad en 6 meses

Arthritis Care Res (Hoboken) 2019 Jan;71(1):71-79. DOI: 10.1002/acr.23585

Van Vollenhoven RF,

Lee EB,

Fallon L,

Zwillich SH,

Wilkinson B,

Chapman D,

Demasi R,

Keystone E

This post-hoc analysis of two, Phase 3 studies, ORAL Start and ORAL Standard shows that early treatment response can predict long-term disease activity outcomes. EULAR recommendations suggest that treat-to-target strategies require regular target assessments with treatment approaches changed if targets are not reached at 6 months. To optimize this strategy, therapy outcomes should be known, and the relationship between short and long-term outcomes defined. The current analysis focused on the dis...

Keywords:

• JAK,
• Tofacitinib,
• Phase 3