Publications

View and download slide summaries of the latest original articles focusing on therapies in immune-mediated inflammatory diseases including rheumatology, dermatology, and gastroenterology. All materials produced by the team are subsequently reviewed and approved by individual Steering Committee members.

November 2023

Long-term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis

Drug Saf 2023;47(1)39–57 doi:10.1007/s40264-023-01361-w

Wang Y,

Li S,

Chakravarty SD,

Chan D,

Shawi M,

Yang YW,

Thaҫi D,

Rahman P.

Data gathered from 11 phase 2 and phase 3 trials have shown that guselkumab has a favourable safety profile in treating psoriatic disease. The data were gathered from 4399 patients over 10787 patient years. In the placebo-controlled periods, guselkumab showed a similar safety profile to placebo, and this remained consistent and stable in the non-placebo controlled preiods.

Keywords:

September 2023

A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of Tildrakizumab Efficacy and Safety in Patients with Active Ankylosing Spondylitis

J Clin Rheumatol. 2023;29(5):223–229 doi: 10.1097/RHU.0000000000001973

Peters E,

Chou RC,

Rozzo SJ,

Yao SL,

Fructuoso FJG

Phase 2a study assessing the efficacy and safety of tildrakizumab in patients with active AS fails to meet the primary endpoint.

Keywords:

Efficacy and Safety of the TYK2/JAK1 Inhibitor Brepocitinib for Active Psoriatic Arthritis: A Phase IIb Randomized Controlled Trial

Arthritis Rheumatol. 2023;75(8):1370–1380 doi: 10.1002/art.42519

Mease P,

Helliwell P,

Silwinska-Stanczyk P,

Miakisz M,

Ostor A,

Peeva E,

Vincent MS,

Sun Q,

Sikirica V,

Winnette R,

Qiu R,

Li G,

Feng G,

Beebe JS,

Martin DA.

Phase IIb study of brepocitinib in patients with PsA concludes that treatment with brepocitinib 30 mg and 60 mg QD, was superior to placebo at reducing signs and symptoms of PsA and was well-tolerated over 52 weeks.

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August 2023

Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients with Rheumatoid Arthritis Receiving Tofacitinib

J Rheumatol. 2023 doi 10.3899/jrheum.2023-0112 Epub ahead of print

Charles-Schoeman C,

Hyde C,

Guan S,

Wang J,

High paraoxonase activity is associated with a significantly reduced risk of MACE and non-NMSC malignancies in white/European RA patients. The PON1 Q192R RR genotype had a significantly greater association with paraoxonase versus the QQ genotype, but had no significant association with MACE or non-NMSC malignancies.

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July 2023

Tofacitinib Reduces Spinal Inflammation in Vertebral Bodies and Posterolateral Elements in Ankylosing Spondylitis: Results from a Phase 2 Trial

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

Wu J,

Wang C,

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.

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Pain and Inflammation as Mediators of Tofacitinib Treatment Effect on Fatigue in Patients with Ankylosing Spondylitis: A Mediation Analysis

Rheumatol Ther 2023;10(4):1073–1087 doi 10.1007/s40744-023-00570-0

Dina O,

Kristensen, et al. used mediation modelling to show that tofacitinib indirectly improved fatigue symptoms via back pain and morning stiffness. This study was carried out using FACIT-F- and BASDAI Q1-based models to determine the relationship between these variables.

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June 2023

Effects of Filgotinib on Semen Parameters and Sex Hormones in Male Patients with Inflammatory Diseases: Results from the Phase 2, Randomised, Double-blind, Placebo-controlled MANTA and MANTA-RAy Studies

Ann Rheum Dis 2023;82:1049–1058

Sikka A,

Mehta R,

Jeka S,

Reinisch, et al. show that filgotinib treatment has no effect on semen parameters for men with active inflammatory diseases. This contrasts with pre-clinical studies that showed fertility issues in male animals.

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May 2023

Evaluation of BMS-986142, a Reversible Bruton’s Tyrosine Kinase Inhibitor, for the Treatment of Rheumatoid Arthritis: A Phase 2, Randomised, Double-blind, Dose-ranging, Placebo-controlled, Adaptive Design Study

Lancet Rheumatol 2023;5:e263–73 doi 10.1016/S2665-9913(23)00089-9

Conaghan PG,

Nowak M,

Du S,

Luo Y,

Fura A,

Investigators from a phase 2 study concluded that further investigation with BMS-986142 (a novel BTK) in people with RA is not necessary.

Keywords:

BTK,
Phase 2

February 2023

Selective Inhibition of the MK2 Pathway: Data From a Phase IIa Randomized Clinical Trial in Rheumatoid Arthritis

ACR Open Rheumatol. 2023;5(2):63–70 doi: 10.1002/acr2.11517

Burt D,

Huff EE,

Hope HR,

Monahan JB

Data show that the first-in-class MK2 pathway inhibitor ATI-450 was well tolerated and induced sustained anti-inflammatory efficacy over 12 weeks in patients with moderate-to-severe RA.

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January 2023

Safety and Efficacy of Bimekizumab in Patients With Active Ankylosing Spondylitis: Three-Year Results From a Phase IIb Randomized Controlled Trial and Its Open-Label Extension Study

Arthritis Rheumatol. 2022;74:1943–58

Molto A,

Vaux T,

In this open-label extension study of BE AGILE, the safety profile of bimekizumab was found to be consistent with previously demonstrated findings, and no new safety signals were identified. The objective was to assess the long-term safety, tolerability, and efficacy of bimekizumab in patients with active AS.