Publications

Janus Kinase Inhibitor—Tofacitinib Associated with Pemphigus: An Analysis of the FDA Adverse Event Reporting System Data

ExpExpert Opin Drug Saf. 2023;22(12):1317–1320 doi: 10.1080/14740338.2023.2248872

Wang L,

Zhao B

This study presents initial data suggesting an association between the use of JAK inhibitors and pemphigus. This research used the FAERS database to investigate connections between JAK inhibitor usage and the occurrence of pemphigus as an adverse event.

Keywords:

• Tofacitinib,
• JAK

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

Effect of dose adjustments on the efficacy and safety of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of an open-label, long-term extension study (ORAL Sequel)

Clin Rheumatol. 2022 Jan 1. Epub ahead of print doi: 10.1007/s10067-021-05908-z

Mueller RB,

Schulze-Koops H,

Furst DE,

Cohen SB,

Kwok K,

Wang L,

Killeen T,

von Kempis J

Post-hoc analysis shows that dosing up from tofacitinib 5 to 10 mg BID is associated with improved efficacy for up to 12 months, versus staying on 5 mg BID, and dosing down from 10 to 5 mg BID is not generally associated with a significant loss of efficacy.Although clinical trials have generally shown no significant differences, in terms of efficacy and safety, when switching tofacitinib dose up or down, these per-protocol switches are not directly informative for clinical decision-making in dai...

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Efficacy,
• Dosing

Incidence Rates of Interstitial Lung Disease Events in Tofacitinib-Treated Rheumatoid Arthritis Patients

J Clin Rheumatol. 2021;27(8):e482–e490

Citera G,

Mysler E,

Madariaga H,

Cardiel MH,

Castañeda O,

Fischer A,

Richette P,

Chartrand S,

Park JK,

Strengholt S,

Rivas JL,

Thorat AV,

Girard T,

Kwok K,

Wang L,

Ponce de Leon D

This post hoc analysis of pooled data from 21 clinical trials in the tofacitinib clinical trial programme highlights the importance of identifying known risk factors of RA-interstitial lung disease (ILD) in clinical practice.Citera, et al. investigated incidence rates of ILD – an extra-articular manifestation of RA – in patients with RA, receiving tofacitinib 5 or 10 mg BID and sort to identify potential risk factors for ILD in these patients....

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Lung / ILD

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

Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies

Rheumatology (Oxford). 2021;60(4):1708-1716.

van der Heijde D,

Landewé RBM,

Wollenhaupt J,

Strengholt S,

Terry K,

Kwok K,

Wang L,

Cohen S.

Long-term evaluation of tofacitinib has found limited progression of structural damage in patients with RA treated with tofacitinib for up to 5 years. Similar results were also observed for patients receiving tofacitinib monotherapy or combination therapy for up to 3 years.It is well known that inflammation in RA leads to structural damage over time, and therapies such as DMARDS have the ability to reduce inflammation whilst inhibiting the progression of structural damage. In this study, van der...

Keywords:

• JAK,
• Tofacitinib,
• LTE,
• Radiographic

Incidence Rates of Interstitial Lung Disease Events in Tofacitinib-Treated Rheumatoid Arthritis Patients

Journal of Clinical Rheumatology, Aug 2020 doi: 10.1097/RHU.0000000000001552.

Citera G,

Mysler E,

Madariaga H,

Cardiel M H,

Castaneda O,

Fischer A,

Richette P,

Chartrand S,

Park J K,

Strengholt S,

Rivas J L,

Thorat A V,

Girard T,

Kwok K,

Wang L

This study highlights the importance of accounting for known risk factors of RA-ILD in clinical practice. Interstitial lung disease (ILD) is an extra-articular manifestation of RA. The post-hoc investigated incidence rates of ILD in patients with RA, receiving tofacitinib 5 or 10 mg twice daily, and identified potential risk factors for ILD. This post-hoc analysis comprised a pooled analysis of patients receiving tofacitinib 5 or 10 mg twice daily or placebo from 21 Phase 1-4, and 2 long-term ex...

Keywords:

• JAK,
• Tofacitinib,
• Safety,
• Lung / ILD

Long-term Effectiveness of Live Herpes Zoster Vaccine in Patients with Rheumatoid Arthritis Subsequently Treated with Tofacitinib

Ann Rheum Dis. 2020 10.1136/annrheumdis-2019-216566

Winthrop KL,

Wouters A,

Choy EH,

Chen C,

Biswas P,

Wang L,

Soma K,

Needle E,

Valdez H,

Rigby WFC

The results of ORAL Sequel suggest that the live zoster vaccine (LZV) may not provide adequate long-term protection in patients with RA receiving TOF. This LTE study enrolled 100 patients with RA, 14 weeks post LZV vaccination. Patients received either TOF 5 mg BID, or TOF 10 mg BID in addition to any background csDMARDs. Incidence rates and 95% CIs for HZ post-vaccination were calculated based on time to first event. Short-term varicella zoster vaccine (VZV) specific immunity was evaluated at ...

Keywords:

• JAK,
• Tofacitinib,
• Vaccination

Safety and Efficacy of Tofacitinib For Up to 9.5 Years in The Treatment of Rheumatoid Arthritis: Final Results of a Global, Open-Label, Long-Term Extension Study

Arthritis Res Ther. 2019 Apr 5;21(1):89.

Wollenhaupt J,

Lee EB,

Curtis JR,

Silverfield J,

Terry K,

Soma K,

Mojcik C,

DeMasi R,

Strengholt S,

Kwok K,

Lazariciu I,

Wang L,

Cohen S

TOF 5 mg and 10mg BID demonstrated a consistent safety profile and sustained efficacy for up to 9.5 years in this open-label LTE ORAL Sequel study.TOF 5 mg and 10 mg BID demonstrated consistent safety (as monotherapy and combination therapy) and efficacy within this open-label LTE study of RA patients. As RA requires long-term treatment, it’s important to assess the long-term efficacy and safety of RA therapies to understand the potential lifelong impact on patient health and quality of life. Th...

Keywords:

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

Evaluation of the Short-, Mid-, and Long-term Effects of Tofacitinib on Lymphocytes in Patients with Rheumatoid Arthritis

Arthritis Rheumatol 2018 DOI: 10. 1002/art.40780

van Vollenhoven R,

Lee EB,

Strengholt S,

Mojcik C,

Valdez H,

Krishnaswami S,

Biswas P,

Lazariciu I,

Hazra A,

Clark JD,

Hodge J,

Wang L,

Choy E

Tofacitinib (TOF) treatment is associated with short-term transient increases in absolute lymphocyte counts (ALC), followed by a gradual decline to reach steady state by ~48 months. Changes in both ALC and lymphocyte subset counts (LSC) were reversible upon TOF discontinuation. Low ALC but not LSC were associated with an increased risk of serious infective episodes (SIEs) and herpes zoster (HZ). This data supported the treatment recommendations on ALC counts for starting and continuing therapy w...

Keywords:

• JAK,
• Tofacitinib,
• MOA