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Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies
ConclusionsThe integrated analysis of a large number of patients detected no new safety signals with long-term CT-P13 treatment. Efficacy in rheumatoid arthritis, psoriasis, Crohn ’s disease, and ulcerative colitis cases was confirmed in biologic-naïve patients and switched patients from the originator infliximab or other biologics.
Source: Drug Safety - September 12, 2023 Category: Drugs & Pharmacology Source Type: research

New Analyses Suggest Favorable Results for STELARA ® (ustekinumab) When Used as a First-Line Therapy for Bio-Naïve Patients with Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, October 25, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two new analyses of STELARA® (ustekinumab) for the treatment of adults with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC).1,2 In a modelled analysisa focused on treatment sequencing using data from randomized controlled trials, network meta-analysis and literature, results showed patient time spent in clinical remission or response was highest when STELARA was used as a first-line advanced therapy for bio-naïve patients with moderately to severely acti...
Source: Johnson and Johnson - October 25, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Infliximab is the new kid on the block in Kawasaki disease: a single-centre study over 8 years from North India.
Authors: Singh S, Sharma D, Suri D, Gupta A, Rawat A, Rohit MK Abstract This was a single-centre study to evaluate the usefulness of tumour necrosis factor-α (TNF-α) blocker, infliximab (IFX), for treatment of Kawasaki disease (KD) in children in Northern Indian. The study was carried out in the Paediatric Allergy-Immunology Unit, Advanced Paediatrics Centre, Post Graduate Institute of Medical Education and Research, Chandigarh. The study period was January 2007 to March 2015. Review of records of 23 children with KD who had received IFX was carried out. Median age at presentation was 2 years (range 2 months to 1...
Source: Clinical and Experimental Rheumatology - April 19, 2016 Category: Rheumatology Tags: Clin Exp Rheumatol Source Type: research

Frequent conversion of tuberculosis screening tests during anti-tumour necrosis factor therapy in patients with rheumatic diseases
Conclusions Approximately one third of patients with negative baseline TB screening develop conversion of at least one screening test during anti-TNF treatment. These findings should be considered when designing re-screening strategies and contemplating latent TB therapy.
Source: Annals of the Rheumatic Diseases - September 9, 2015 Category: Rheumatology Authors: Hatzara, C., Hadziyannis, E., Kandili, A., Koutsianas, C., Makris, A., Georgiopoulos, G., Vassilopoulos, D. Tags: Immunology (including allergy), Radiology, Connective tissue disease, Degenerative joint disease, Musculoskeletal syndromes, Rheumatoid arthritis, Clinical diagnostic tests, Radiology (diagnostics), Epidemiology Clinical and epidemiological research Source Type: research

Are patients with rheumatoid arthritis still at an increased risk of tuberculosis and what is the role of biological treatments?
Conclusions In the past decade, the risk of TB has decreased among biological-exposed RA patients but remains higher than in biological-naïve RA patients. Most cases of TB in RA occur in biological-naïve RA patients, underscoring the elevated risk also in these patients.
Source: Annals of the Rheumatic Diseases - May 8, 2015 Category: Rheumatology Authors: Arkema, E. V., Jonsson, J., Baecklund, E., Bruchfeld, J., Feltelius, N., Askling, J., Coster, Forsblad, Geborek, Jacobsson, Klarskog, Kristensen, Lindblad, Rantapaa-Dahlqvist, van Vollenhoven, on behalf of the ARTIS Study Group Tags: Immunology (including allergy), Connective tissue disease, Degenerative joint disease, Musculoskeletal syndromes, Rheumatoid arthritis, Epidemiology Clinical and epidemiological research Source Type: research

Safety of synthetic and biological DMARDs: a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis
Conclusions The findings from this SLR confirm the known safety pattern of sDMARDs and bDMARDs for the treatment of RA.
Source: Annals of the Rheumatic Diseases - February 4, 2014 Category: Rheumatology Authors: Ramiro, S., Gaujoux-Viala, C., Nam, J. L., Smolen, J. S., Buch, M., Gossec, L., van der Heijde, D., Winthrop, K., Landewe, R. Tags: Immunology (including allergy), Biological agents, Connective tissue disease, Degenerative joint disease, Drugs: musculoskeletal and joint diseases, Musculoskeletal syndromes, Rheumatoid arthritis Clinical and epidemiological research Source Type: research

Factors associated with withdrawal of the anti‐TNFα biologics in the treatment of rheumatic diseases: data from the Hong Kong Biologics Registry
ConclusionsIn our registry, the retention rate of the anti‐TNFα agents was lowest but the incidence of tuberculosis, serious infections and infusion reaction was highest with IFX. Older female patients with RA and the use of IFX were independently associated with drug withdrawal.
Source: APLAR Journal of Rheumatology - December 30, 2013 Category: Rheumatology Authors: Chi Chiu Mok, Ka Yan Chan, Ka Lai Lee, Lai Shan Tam, Ka Wing Lee, Tags: Original Article Source Type: research

A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study
Conclusions The PK profiles of CT-P13 and INX were equivalent in patients with active AS. CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of INX up to week 30.
Source: Annals of the Rheumatic Diseases - September 4, 2013 Category: Rheumatology Authors: Park, W., Hrycaj, P., Jeka, S., Kovalenko, V., Lysenko, G., Miranda, P., Mikazane, H., Gutierrez-Urena, S., Lim, M., Lee, Y.-A., Lee, S. J., Kim, H., Yoo, D. H., Braun, J. Tags: Open access, Editor's choice, Immunology (including allergy), Ankylosing spondylitis, Connective tissue disease, Degenerative joint disease, Musculoskeletal syndromes, Rheumatoid arthritis, Calcium and bone Clinical and epidemiological research Source Type: research