Rozibafusp alfa (AMG 570) is a first-in-class bispecific antibody-peptide conjugate targeting T-cell and B-cell activity by inhibiting both the inducible costimulator ligand (ICOSL) and the B cell-activating factor (BAFF). This phase 1b study reported on the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of rozibafusp alfa in RA patients. Enrolled in the study were 34 Â patients aged between 18 and 75 years with active RA defined as a disease activity score (DAS28-CRP) >2.6. Patients were randomised 3:1 to receive rozibafusp alfa or placebo subcutaneously every 2 weeks for 10 weeks (6 doses) into 4 separate groups of ascending doses of rozibafusp alfa, with 24 weeks of follow-up. All patients were also treated with a stable dose of methotrexate. Primary endpoint of the study was the subject incidence of treatment-emergent adverse events (TEAEs).
The results of the interim analysis show that rozibafusp alfa was generally well tolerated by patients. TEAEs were seen in 92.3% of patients being treated with rozibafusp alfa and in 87.5% of those on placebo. Most of these events were grade â€2, and the most common TEAE was upper respiratory infection (23.1%) for subjects receiving rozibafusp alfa and nasopharyngitis (37.5%) for subjects receiving placebo. No grade â„3 treatment-related AEs were observed. Although 11.1% patients who received rozibafusp alfa developed anti-rozibafusp alfa antibodies, there was no correlation to safety or AEs. The preliminary analysis of disease-related activity showed a trend for greater numerical improvement from baseline in PtGA and PhGA with rozibafusp alfa versus placebo in the cohorts receiving the 2 highest doses.
Based on the findings of this trial, further research is underway, with a phase 2, randomised, placebo-controlled study to assess the efficacy and safety of rozibafusp alfa in subjects with active systemic lupus erythematosus (SLE) and inadequate responses to standard-of-care therapy.
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Table of Contents: EULAR 2020
Featured articles
COVID-19 and inflammatory rheumatic disease: some key issues
Secukinumab monotherapy as efficient as adalimumab
AxSpA real-life remission rates higher on biologics
Olokizumab significantly improves RA features and patient-reported outcomes
Rheumatoid Arthritis
New nanoparticle promising future agent in RA
Olokizumab significantly improves RA features and patient-reported outcomes
Low DAS at 4 months predicts sustained DMARD-free remission
Ankylosing Spondylitis
Reduced maintenance dose of certolizumab pegol can be used in axSpA
Worse response axSpA patients to second TNFi versus first TNFi
AxSpA real-life remission rates higher on biologics
Certolizumab pegol reduces acute anterior uveitis in axial spondyloarthritis
TNF-α inhibitors improve bone mineral density in AS patients
Psoriatic Arthritis
Ixekizumab shows sustained improvements in pain and fatigue at 3 years
Adalimumab added to methotrexate yields better results in PsA than methotrexate escalatio
Upadacitinib provides fast onset of improvement in psoriatic arthritis
Secukinumab monotherapy as efficient as adalimumab
Osteoporosis and Osteoarthritis
Higher mortality risk with tramadol versus NSAIDs for osteoarthritis patients
Hydroxychloroquine not effective in patients with hand osteoarthritis
Positive effect denosumab on fall risk
Systemic Sclerosis and Systemic Lupus Erythematosus
Anifrolumab achieves rapid and durable BICLA-response
Subclinical myocardial involvement progresses in SSc patients
Composite endpoint CRESS for primary Sjögrenâs syndrome
COVID-19
COVID-19 and inflammatory rheumatic disease: some key issues
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