Objective: CXCL10 (also known as interferon-γ-inducible 10-kd protein [IP-10]) is a chemokine that potentially plays a role in the immunopathogenesis of rheumatoid arthritis (RA). We undertook this phase II study to evaluate the efficacy and safety of MDX-1100, a fully human, anti-CXCL10 (anti-IP-10) monoclonal antibody, in RA patients whose disease responded inadequately to methotrexate (MTX).
Methods: Patients with active RA receiving stable doses of MTX (10-25 mg weekly) were randomized to receive intravenous doses of 10 mg/kg MDX-1100 (n = 35) or placebo (n = 35) every other week. The primary end point was the proportion of patients meeting the American College of Rheumatology 20% improvement criteria (achieving an ACR20 response) on day 85, and patients were followed up for safety to day 141.
Results: The ACR20 response rate was significantly higher among MDX-1100-treated patients than among placebo-treated patients (54% versus 17%; P = 0.0024). Statistically significant differences in the ACR20 response rate between treatments were observed starting on day 43 (P < 0.05). The ACR50 and ACR70 response rates on day 85 did not differ between the groups. Overall, 51.4% of MDX-1100-treated patients and 30.3% of placebo-treated patients experienced at least 1 adverse event (AE). No study drug-related serious AEs were reported.
Conclusion: MDX-1100 was well tolerated and demonstrated clinical efficacy in RA patients whose disease responded inadequately to MTX. This is the first study to demonstrate clinical efficacy of a chemokine inhibitor in RA and supports the notion of a potential role of IP-10 in the immunopathogenesis of RA.
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http://dx.doi.org/10.1002/art.34330 | DOI Listing |
Regen Med
December 2024
Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Aims: This phase I trial assessed the safety and potential efficacy of monthly 3 dose intravenous infusion of allogeneic bone marrow-derived clonal mesenchymal stromal cells (BM-cMSCs) in refractory rheumatoid arthritis (RA) patients over 24 weeks.
Patients & Methods: Six patients with refractory RA received BM-cMSC infusions at one-month intervals over a 24-week period. Safety outcomes included adverse events (AEs) and serious adverse events (SAEs).
PeerJ
December 2024
Department of Rheumatology, The First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, Jiangxi Province, China.
Objective: Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease, characterized by significant individual variations in treatment response. Predicting treatment response remains a formidable challenge. This study aims to identify predictors within the synovium associated with the response to JAK inhibitor therapy in RA patients, employing a retrospective approach.
View Article and Find Full Text PDFSyst Rev
November 2024
Program of Evidence for Health Policy and Technologies, Oswaldo Cruz Foundation- Fiocruz Brasília, DF, 70.910-900, Brazil.
Background: Biosimilar etanercept presents itself as an innovative therapeutic opportunity for inflammatory and autoimmune diseases, however, its efficacy, safety, and immunogenicity in relation to the reference biological agent for the treatment of rheumatoid arthritis is still questioned. With this in mind, this study aimed to verify the efficacy, safety, and immunogenicity of the use of the biosimilar etanercept in relation to the reference biologic in patients over 18 years of age with rheumatoid arthritis.
Methods: A systematic review with meta-analysis was performed in accordance with the parameters of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) selecting only Phase III randomized clinical trials.
Ann Rheum Dis
November 2024
Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Beijing, China
Front Pharmacol
October 2024
Department of Rheumatology, Rehabilitation, and Physical Medicine, Faculty of Medicine, Menoufia University, Menoufia, Egypt.
Background: Inflammation and angiogenesis are two main mechanisms that act as mutual pathways in rheumatoid arthritis (RA). This work aimed to study the efficacy of digoxin as an adjunct therapy to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) in active RA patients.
Methods: In a randomized, double-blinded, placebo-controlled study, 60 adult patients with active RA received a placebo or digoxin (0.
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