April 2024

Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): A randomised, double-blind, active-comparator-controlled Phase 3 trial

Lancet 2019;394:576–86. doi: 10.1016/S0140-6736(19)30952-3

Treatment with risankizumab showed significantly greater efficacy over adalimumab in providing substantial skin clearance in patients with moderate-to-severe chronic plaque PsO. This study aimed to assess the safety and efficacy of risankizumab compared with adalimumab in an active-comparator Phase 3 trial.

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December 2019

Highlights of 2019

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

2019 was another remarkable year in cytokine signalling. We can be optimistic that clinical practice for inflammatory arthritis will continue to improve, with promising long-term safety data supporting the use of established JAK inhibitors; tofacitinib and baricitinib, in addition to exciting phase III clinical data for filgotinib and newly approved upadacitinib. You can find the most notable papers, as selected by CSF Steering Committee Chair Professor Iain McInnes, with links to their respecti...

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November 2019

Analyses Exposition-Réponse de l'Efficacité et de l'Innocuité de l'Upadacitinib Dans des Études de Phases 2 et 3 Pour Étayer l'Évaluation Bénéfices-Risques Dans la Polyarthrite Rhumatoïde

Clin Pharmacol Ther . 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671.

UPA 15 mg provided the optimal benefit-risk in RA through maximizing efficacy with only small incremental benefit with 30 mg, and with consistency across RA subpopulations and with UPA monotherapy or combination with csDMARDs. Exposure-response analyses were conducted using combined data from two Phase 2b and five Phase 3 studies in order to characterise the relationship between plasma exposure and efficacy, as well as to select safety parameters using the totality of the data in subjects with R...

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October 2019

Facteurs de Risque d'Événements Cardiovasculaires Indésirables Majeurs Dans les Études de Phase III et de Prolongation à Long Terme du Tofacitinib chez les Patients Atteints de Polyarthrite Rhumatoïde

Arthritis Rheumatol .2019 Sep;71(9):1450-1459. doi: 10.1002/art.40911. Epub 2019 Aug 6.

Post hoc analyses of the six ORAL studies and two LTE’s suggested that after 24 weeks of TOF treatment, increases in HDL-c and decreases in the TC/HDL-c ratio appeared to be associated with reduced future MACE risk in RA patients. 52 MACE occurred in 4076 patients over 12873 patient-years of exposure. Separate Cox regression models were used to evaluate traditional CV risk factors’ association with time to first MACE at baseline and changes in lipid levels with time to future MACE after 24 weeks...

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Évolution des Taux Lipidiques et de l'Incidence des Événements Cardiovasculaires Après un Traitement au Tofacitinib chez les Patients Atteints de Rhumatisme Psoriasique : Une Analyse Regroupée des Études de Phase 3 et de Prolongation à Long Terme

Arthritis Care Res (Hoboken) 2019;71(10):1387–95

Serum lipid level increases at month 3 following TOF treatment in PsA were consistent with observation in RA and psoriasis. The risk of CV disease is higher in people with PsA versus the general population – comparable with the well-documented rates seen in RA and diabetes. The reasons for this are not fully elucidated, but it has been suggested that there is an association between peripheral joint inflammation and lipid dysregulation in PsA. This post hoc analysis of pooled data from OPAL Broad...

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Effet du Baricitinib et de l'Adalimumab sur la Réduction de la Douleur et l'Amélioration Fonctionnelle Chez les Patients Atteints de Polyarthrite Rhumatoïde en Cas de Faible Activité de la Maladie : Analyses Exploratoires de la RA-BEAM

J Clin Med. 2019 Sep 5;8(9). pii: E1394

Post hoc analyses from RA-BEAM concluded that BARI 4 mg QD or ADA 40 mg Q2W resulted in improvements in pain, physical function, fatigue and work productivity in patients with RA, independent of the treatment’s impact on inflammation. Among patients achieving remission or LDA, greater improvements in pain and physical function were seen with BARI than with ADA or PBO.Of 1010 patients included in the analysis at Week 24, 168 were in remission, 310 were in remission/LDA and 700 were not in remissi...

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August 2019

Peficitinib | Methotrexate | Phase 3

Ann Rheum Dis 2019 DOI: 10.1136/annrheumdis-2019-215164

Peficitinib (PEF) 100 and 150 mg demonstrated robust clinical and structural efficacy in patients with RA who have an inadequate response to MTX. In Japan, two JAK inhibitors, TOF and BARI are currently available for RA patients with an inadequate response to conventional therapies. This randomized phase 3 study (RAJ4), assessed the efficacy and safety of two PEF doses in combination with MTX compared to PBO, in Japanese MTX-IR. Patients were randomized 1:1:1 to PBO, PEF 100 mg and 150 mg with M...

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Effet du Filgotinib par rapport au placebo sur la réponse clinique chez des patients atteints de Polyarthrite Rhumatoïde modérée à sévère réfractaire au traitement antirhumatismal modificateur de la maladie: l'essai clinique randomisé FINCH 2

JAMA 2019 322(4):315-325

Among RA patients with an inadequate response or intolerance to bDMARDs, filgotinib (FIL) doses, compared to PBO resulted in significantly greater proportions achieving a clinical response at Wk12.Patients with active RA despite treatment with bDMARD therapy need treatment options. The FINCH 2 Phase 3 study compared the effects of FIL vs PBO for the treatment of RA patients with inadequate response or intolerance to ≥1 prior bDMARDs. Patients were randomized in a 1:1:1 ratio, receiving FIL 200 m...

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Upadacitinib versus Placebo ou Adalimumab chez des patients atteints de polyarthrite rhumatoïde avec une réponse inadéquate au Méthotrexate: Résultats d'un essai contrôlé de phase 3, randomisé et à double aveugle

Arthritis Rheumatol 2019 DOI: 10.1002/art.41032

UPA demonstrated superiority to ADA in terms of clinical, functional and patient-reported outcomes with comparable radiographic inhibition. As many RA patients fail to achieve LDA and remission with TNF inhibitors and MTX there is a requirement for additional treatment options. In this SELECT-COMPARE study the clinical and functional outcomes of UPA were compared to ADA in MTX-IR patients. 1629 MTX-IR were randomly assigned 2:2:1 to; UPA 15mg QD, ADA 40mg Q2W or PBO, with background MTX. Key end...

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Innocuité et efficacité de l'Upadacitinib ou de Adalimumab plus Méthotrexate chez les patients atteints de polyarthrite rhumatoïde pendant plus de 48 semaines avec passage à un traitement alternatif chez des patients présentant une réponse insuffisante

Ann Rheum Dis 2019 DOI: 10.1136/annrheumdis-2019-215764

Consistent with Wk26 data, significantly more UPA patients achieved LDA and remission versus ADA and PBO over 48 weeks. RA patients often change therapy due to inadequate response and intolerance. The SELECT COMPARE study was designed to explore switching to JAK inhibitors from TNF inhibitors without a wash-out period (and vice versa). The long-term safety and efficacy of UPA was compared to ADA and PBO in MTX-IR.1629 patients were blindly assigned 2:2:1 to; UPA 15mg QD, ADA 40mg Q2W and PBO, wi...

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