Publications

Long-term etanercept response for patients with radiographic axial spondyloarthritis based on achievement of early, intermediate, or late responses during index studies

Rheumatol Ther 2024 doi: 10.1007/s40744-024-00656-3

Baraliakos X,

Szumski A,

Kwok K,

Vlahos B,

Borlenghi C

This post-hoc analysis by Baraliakos, et al. found a response in short-term index studies was maintained in the long-term OLE studies, and where no response occurred in the index studies, continued treatment led to a response in a large proportion of patients.

Keywords:

• Phase 3,
• Phase 4

Tofacitinib versus Methotrexate as the First-line Disease-modifying Antirheumatic Drugs in the treatment of Rheumatoid Arthritis: An Open-label Randomized Controlled Trial

Int J Rheum Dis. 2023;26(9):1729–1736 doi: 10.1111/1756-185X.14801

Khan MM,

Ahmed S,

Hasan Sajib MK,

Morshed AA,

Mahbub-Uz-Zaman K,

Haq SA.

This single-centre study by Khan, et al. suggests that high-dose methotrexate (25 mg/week, subcutaneously) may be as efficacious as tofacitinib in patients with established RA who are DMARD naïve or have not received a therapeutic dose of DMARDs.

Keywords:

• JAK,
• Tofacitinib,
• Efficacy,
• Phase 4

Baricitinib Improves Bone Properties and Biomechanics in Patients with Rheumatoid Arthritis – Results of the Prospective Interventional BARE BONE Trial

Arthritis Rheumatol. 2023 doi 10.1002/art.42617 Epub ahead of print

Simon D,

Minopoulou I,

Kemenes S,

Bayat S,

Tascilar K,

Multu MY,

Valor-Méndez L,

Krönke G,

Hueber AJ,

Schett G,

Kleyer A

The results from Simon, et al. show that baricitinib treatment correlates with improvements in bone stiffness. Further improvements were also observed at the end of Week 52, with an increase in estimated failure load and no measurable progression in bone erosion being reported.

Keywords:

• JAK,
• Baricitinib,
• Bone

Outcomes of Dose Reduction, Withdrawal, and Restart of Tofacitinib in Patients with Rheumatoid Arthritis: A Prospective Observational Study

Clin Rheumatol. 2019 Aug 9. DOI: 10.1007/s10067-019-04721-z

Mori S,

Ueki Y

Following achievement of remission or low disease activity (LDA), a dose reduction strategy of TOF to a 5mg QD dose was preferable to immediate withdrawal of TOF, with lower relapse rates.Clinical remission or LDA early in the disease course is a target for every RA patient. Although maintaining a state of remission or LDA is beneficial to patients, the AEs and costs associated with DMARDs, have significant burdens on patients during life-long RA treatment. This long-term study was performed to ...

Keywords:

• JAK,
• Tofacitinib,
• Phase 4,
• Dosing

Professor Iain McInnes Reviews the Most Notable Papers from 2018

Please click the links below to go to the CSF review of each paper

McInnes. I

2018 brought a wealth of new data in cytokine signalling and IL-6 that helps inform current clinical practice and brings the promise of new options in the future. There was good data on the use of sub cutaneous tocilizumab as well as strategies in early RA and for methotrexate tapering. For the currently marketed JAK inhibitors, tofacitinib and baricitinib, continuous long-term efficacy and safety data further support its current use and applications. On the development side, the outcomes of the...

Keywords:

• Review

Subcutaneous Tocilizumab in Rheumatoid Arthritis: Findings from the Common-framework Phase 4 Study Programme TOZURA Conducted in 22 Countries

Rheumatology (Oxford). 2018 Mar 1;57(3):499-507. DOI: 10.1093/rheumatology/kex443

Choy E,

Caporali R,

Xavier R,

Fautrel B,

Sanmarti R,

Bao M,

Bernasconi C,

Pethö-Schramm A

This multi-national TOZURA study programme confirmed the efficacy and safety profile of subcutaneous tocilizumab (TC-SC) when administered as either monotherapy or in combination with csDMARDs. TOZURA was a Phase 4 study programme that evaluated open-label, TCZ-SC in patients with moderate-to-severe RA. A total of 1804 patients with active RA were enrolled in the study programme. Patients had inadequate responses to csDMARDs, anti-TNF therapies, or they were MTX-naïve. TCZ-SC was administered we...

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 Tofacitinib Monotherapy, Tofacitinib with Methotrexate, and Adalimumab with Methotrexate in Patients with Rheumatoid Arthritis (ORAL Strategy): A Phase 3b/4, Double-Blind, Head-To-Head, Randomised Controlled Trial

Lancet. 2017 Jul 29;390(10093):457-468. doi: 10.1016/S0140-6736(17)31618-5

Fleischmann R,

Mysler E,

Hall S,

Kivitz A,

Moots R,

Luo Z,

DeMasi R,

Soma K,

Zhang R,

Takiya L,

Tatulych S,

Mojcik C,

Krishnaswami S,

Menon S,

Smolen J,

on behalf of the ORAL Strategy investigators

In this first head-to-head non-inferiority trial assessing a JAKi ± MTX directly compared with a TNFi + MTX in patients with RA, tofacitinib (TOF) + MTX showed non-inferiority to adalimumab (ADA) + MTX. Non-inferiority was not shown for TOF monotherapy versus TOF + MTX, or versus ADA + MTX.In this 52-week study, MTX-inadequate responder (IR) patients were randomised 1:1:1 to receive TOF 5 mg BID monotherapy, TOF 5 mg BID + MTX or ADA 40 mg every other week + MTX. The primary endpoint, ACR50 resp...

Keywords:

• JAK,
• Tofacitinib,
• Phase 4,
• Phase 3

Switching from Adalimumab to Tofacitinib in the Treatment of Patients with Rheumatoid Arthritis

Arthritis Research & Therapy. 2016. DOI 10.1186/s13075-016-1049-3 [Epub ahead of print]

Genovese,

et al.

Results are reported from an analysis exploring the safety and efficacy of open-label tofacitinib (TOF) following blinded treatment with TOF or adalimumab (ADA) in patients with moderate to severe RA. The analysis included patients from ORAL Sequel, an open-label long-term extension study, which all patients entered following ORAL Standard (one of the studies in the TOF phase 3 program). Only those patients who had been randomized to ADA 40 mg Q2W + MTX or 10 mg TOF + MTX in ORAL Standard were i...

Keywords:

• JAK,
• Tofacitinib,
• Phase 4,
• Switching

The effect of tofacitinib on pneumococcal and influenza vaccine responses in rheumatoid arthritis

Ann Rheum Dis. 2015 Mar 20. pii: annrheumdis-2014-207191. doi: 10.1136/annrheumdis-2014-207191. [Epub ahead of print]

Winthrop KL,

Silverfield J,

Racewicz A,

Neal J,

Lee EB,

Hrycaj P,

Gomez-Reino J,

Soma K,

Mebus C,

Wilkinson B,

Hodge J,

Fan H,

Wang T,

Bingham CO 3rd.

The increased risk of serious infection among RA patients means vaccinations against pneumococcus and influenza are recommended in this group of patients. Studies evaluating immune response to these vaccines in conjunction with DMARD therapy can provide clinicians with important information relating to things such as timing of vaccination.

This study aimed to assess the effect of tofacitinib on vaccine responses to PPSV-23 and the trivalent seasonal influenza vaccine in those whom tofacit...

Keywords:

• JAK,
• Tofacitinib,
• Phase 4,
• Vaccination