August 2024

Risankizumab versus ustekinumab for moderate-to-severe Crohn’s disease

N Engl J Med. 2024 Jul 18;391(3):213-223. DOI 10.1056/NEJMoa2314585

Risankizumab was noninferior to ustekinumab with respect to clinical remission at Week 24, and superior with respect to endoscopic remission at Week 48. This study aimed to present data from SEQUENCE, a direct head-to-head trial assessing the efficacy and safety of risankizumab vs ustekinumab in patients with moderate-to-severe CD, in whom at least one anti-TNF treatment had failed.

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June 2024

Maintenance risankizumab sustains induction response in patients with Crohn’s disease in a randomized Phase 3 trial

J Crohns Colitis 2024;18:416–423 doi: 10.1093/ecco-jcc/jjad168

Subcutaneous risankizumab maintenance therapy results in durable improvement in clinical and endoscopic outcomes over one year in patients with moderately to severely active Crohn’s disease. Endpoint achievement tended to be achieved in a higher proportion of patients treated with 360mg risankizumab than 160mg risankizumab, and both doses were higher when compared to placebo.

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May 2024

Risk of extended major adverse cardiovascular event endpoints with tofacitinib versus TNF inhibitors in patients with rheumatoid arthritis: A post hoc analysis of a Phase 3b/4 randomised safety study

RMD Open 2024;10:e003912 doi: 10.1136/rmdopen-2023-003912

Risk of composite CV endpoints combining all ischaemic CV events and heart failure were similar for individual and combined TOF doses versus TNFi. The totality of CV risk (MACE-8 plus VTE) was higher with TOF 10mg twice daily versus TNFi. Buch et al conducted a post-hoc analysis on the ORAL Surveillance trial to assess risk across extended MACE endpoints in RA patients treated with either TOF 5mg, TOF 10mg, or TNFi.

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Risankizumab as maintenance therapy for moderately to severely active Crohn’s disease: Results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal Phase 3 FORTIFY maintenance trial

Lancet 2022;399:2031–36 doi: 10.1016/S0140-6736(22)00466-4

Maintenance treatment with risankizumab was associated with an improvement in coprimary endpoints of clinical remission and endoscopic response in patients with Crohn’s disease compared with placebo.

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Risankizumab as induction therapy for Crohn’s disease: Results from the phase 3 ADVANCE and MOTIVATE induction trials

Lancet 2022;399:2015–30 doi 10.1016/S0140-6736(22)00467-6

Risankizumab was effective and well tolerated as induction therapy in patients with moderately to severely active Crohn’s disease, though there were no significant differences in efficacy between 600mg and 1200mg doses.

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April 2024

Risk of venous thromboembolism with tofacitinib versus tumor necrosis factor inhibitors in cardiovascular risk-enriched rheumatoid arthritis patients

Arthritis Rheumatol 2024 doi: 10.1002/art.42846 Epub ahead of print https://pubmed.ncbi.nlm.nih.gov/38481002/

This post hoc analysis of ORAL Surveillance showed that incidence of venous thromboembolism (VTE) events was higher in patients with RA treated with tofacitinib (10>5mg BID) versus TNFi. Across treatments, VTE risk factors (age, BMI, and VTE history) were aligned with previous studies in the general RA population.

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February 2024

Efficacy and safety of JAK inhibitors in rheumatoid arthritis: update for the practising clinician

Nat Rev Rheumatol 2024;20(2):101–115 DOI: 10.1038/s41584-023-01062-9

The observed benefit:risk ratio strongly favours JAKi use in the majority of patients, and HCPs should consider and adhere to guidance on high-risk patients where applicable. Szekanecz et al summarised the safety and efficacy of approved JAKis tofacitinib, baricitinib, upadacitinib, and filgotinib to aid in clinical decision making.

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December 2023

Rheumatoid Arthritis Disease Activity and Adverse Events in Patients Receiving Tofacitinib or Tumor Necrosis Factor Inhibitors: A Post Hoc Analysis of ORAL Surveillance

Ther Adv Musculoskelet Dis. 2023;15:1759720X231201047 doi: 10.1177/1759720X231201047

Post hoc analysis of ORAL Surveillance data highlights that active disease in RA leads to higher risk of adverse medical events, regardless of medication used.

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February 2023

Impact of Cardiovascular Risk Enrichment on Incidence of Major Adverse Cardiovascular Events in the Tofacitinib Rheumatoid Arthritis Clinical Programme

Ann Rheum Dis. 2023;82(4):575–577 doi: 10.1136/ard-2022-223406

Data suggest that an important difference between P123LTE and ORAL Surveillance was the proportion of patients with a history of atherosclerotic CV disease (ASCVD).

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October 2022

Risk of MACE with Tofacitinib Versus TNFi in Patients with RA With or Without a History of Atherosclerotic CV: A Post Hoc Analysis from ORAL Surveillance

Ann Rheum Dis. 2022. doi: 10.1136/ard-2022-222259

Post hoc analysis from ORAL Surveillance observes higher major adverse cardiovascular events (MACE) risk with tofacitinib vs TNFi in patients with RA and history of atherosclerotic cardiovascular disease (ASCVD).

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