Publications

Clinical trial: Association between early disease clearance and long-term outcomes—4-year results from the Phase 3 UNIFI study of ustekinumab in ulcerative colitis

Alimentary Pharmacology & Therapeutics 2025;62:483–492 Doi: 10.1111/apt.70264

Danese S,

Leong RW,

Sands BE,

Ma T,

Marano C,

Peyrin-Biroulet L

Danese et al. showed that patients who achieved disease clearance 8 weeks after ustekinumab induction were more likely to be in long-term clinical, symptomatic and quality of life remission with ustekinumab maintenance treatment than patients who did not. Authors evaluated disease clearance in the Phase 3 UNIFI program and its association with long-term outcomes.

Keywords:

• Efficacy,
• GI,
• Outcomes,
• IBD,
• Phase 3

Clinical Efficacy of Alternative TNF Inhibitor and Secukinumab Between Primary Non-responder and Secondary Non-responder of Prior TNF Inhibitor in Ankylosing Spondylitis

Mod Rheumatol. 2023 doi: 10.1093/mr/roac005

Min HK,

Kim HR,

Lee SH,

Hong YS,

Kim MY,

Park SH,

Kang KY

This study demonstrated comparable drug retention between AS patients treated with alternative TNFi and secukinumab after failing to respond to prior TNFi therapy. The objective of this study was to compare the drug retention times and clinical efficacy of alternative TNFi and secukinumab in primary and secondary
non-responders with AS.

Keywords:

• IL-17,
• Secukinumab,
• Efficacy

Comparison of drug retention of TNF inhibitors, other biologics and JAK inhibitors in RA patients who discontinued JAK inhibitor therapy

Rheumatology (Oxford) 2022 doi: 10.1093/rheumatology/keac285

Amstad A,

Papagiannoulis E,

Scherer A,

Rubbert-Roth A,

Finckh A,

Mueller R,

Dudler J,

Möller B,

Villiger PM,

Schulz MMP,

Kyburz D

Real-world population-based study shows that a switch to a second JAKinib results in a higher drug retention, as compared to switching to a TNFi, in patients with RA who discontinue original JAKinib therapy.

Keywords:

• JAK,
• Switching

Comparison of the effects of baricitinib and tocilizumab on disease activity in patients with rheumatoid arthritis: a propensity score matching analysis

Clin Rheumatol. 2021 Jun 16. DOI: 10.1007/s10067-021-05815-3

Asai S,

Takahashi N,

Kobayakawa T,

Kaneko A,

Watanabe T,

Kato T,

Nishiume T,

Ishikawa H,

Yoshioka Y,

Kanayama Y,

Watanabe T,

Hirano Y,

Hanabayashi M,

Yabe Y,

Yokota Y,

Suzuki M,

Terabe K,

Ishiguro N,

Imagama S,

Kojima T.

The influence of inflammation on patient global assessment (PGA) improvements differs between baricitinib and tocilizumab differs. Adequate PGA improvement remains one of the unmet needs in current RA treatment.Asai, et al. compared the effects of baricitinib and tocilizumab on disease activity in patients with RA while investigating the influence of inflammation on PGA improvement.Using data from a multicentre registry, 48 propensity-matched pairs of patients, who had been observed for longer t...

Keywords:

• JAK,
• IL-6,
• Baricitinib,
• Tocilizumab,
• Efficacy

Tofacitinib versus tocilizumab in the treatment of biological-naïve or previous biological-failure patients with methotrexate-refractory active rheumatoid arthritis

RMD Open. 2021;7(2):e001601.

Mori S,

Urata Y,

Yoshitama T,

Ueki Y.

Findings from a multicentre cohort study in Japan provide important information that is expected to aid in determining the position of tofacitinib in the treatment algorithm for RA.Mori S, et al. compared therapeutic outcomes, from real-world registries, at 12 months between tofacitinib-treated and tocilizumab-treated patients to clarify whether tofacitinib should only be considered as an option for patients who have either failed to respond to at least one bDMARD or are MTX-resistant/-intoleran...

Keywords:

• JAK,
• IL-6,
• Tofacitinib,
• Tocilizumab,
• Efficacy,
• Safety

IgA Vasculitis Developed as an Adverse Effect of Tofacitinib Taken for Rheumatoid Arthritis

Intern Med. 2020;59(6):817-821

Itoh I,

Kasuno K,

Yamamoto C,

Takahashi N,

Shimizu H,

Ojima T,

Hayashi S,

Kimura H,

Iwano M

Nephrotoxicity is a key side effect of NSAIDs and DMARDs used to treat RA, while biologics can reportedly cause proliferative glomerulonephritis or crescentic glomerulonephritis. This report reviews a patient on TOF presenting IgA vasculitis as an adverse effect that fully resolved following termination of TOF.Drug induced IgA vasculitis has been previously described for anti-TNFɑ therapies, but this is the first report with JAK inhibitor therapy. This is a case report of a 67-year old woman wit...

Keywords:

• JAK,
• Tofacitinib,
• Safety

Tofacitinib Therapy for Rheumatoid Arthritis: A Direct Comparison Study between Biologic-naive and Experienced Patients

Intern Med. 2018 Mar 1;57(5):663-670. doi: 10.2169/internalmedicine.9341-17

Mori S,

Yoshitama T,

Ueki Y

This 6-month prospective direct comparison study analysed the effectiveness of tofacitinib (TOF) therapy on bDMARD-naïve and bDMARD-experienced patients. bDMARD-naïve patients were more responsive to TOF therapy than bDMARD-experienced patients.The study analysed the data of 113 patients diagnosed with high or moderate disease activity, defined using CDAI scores. All patients had failed to achieve CDAI low disease activity or remission with MTX therapy for ≥3 months. Patients were given 5 mg TOF...

Keywords:

• JAK,
• Tofacitinib,
• Phase 4

Efficacy and Safety of Sirukumab in Patients with Active Rheumatoid Arthritis Refractory to Anti-TNF Therapy (SIRROUND-T): A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multinational, Phase 3 Study

Lancet 2017;pii:S0140-6736(17)30401-4

Aletaha D,

Bingham CO 3rd,

Tanaka Y,

Agarwal P,

Kurrasch R,

Tak PP and Popik S

In this Phase 3 multicentre, randomised controlled trial in patients with active RA who were refractory or intolerant to previous biological treatment with at least one TNF inhibitor, sirukumab 50 mg every four weeks (Q4W) or 100 mg every two weeks (Q2W) was well tolerated and significantly improved signs and symptoms of disease.Patients were randomised 1:1:1 to placebo (n=294), sirukumab 50 mg Q4W (n=292) or sirukumab 100 mg Q2W (n=292), while continuing any concomitant DMARDs. Of the 878 rando...

Keywords:

• IL-6,
• Sirukimab,
• Phase 3