scholarly journals FRI0094 LONG TERM DRUG SURVIVAL FOR BIOSIMILAR SB4 ETANERCEPT IN RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS AND AXIAL SPONDYLOARTHRITIS PATIENTS WITH A NON-MEDICAL SWITCH FROM ETANERCEPT REFERENCE DRUG

2019 ◽  
Author(s):  
Glenn Haugeberg ◽  
Bjørg Tilde Svanes Fevang ◽  
Gunnstein Bakland ◽  
Erik Rødevand ◽  
Andreas Diamantopoulos
Keyword(s):  
Rheumatoid Arthritis ◽  
Psoriatic Arthritis ◽  
Axial Spondyloarthritis ◽  
Reference Drug ◽  
Drug Survival

scholarly journals Long-term safety of certolizumab pegol in rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis and Crohn’s disease: a pooled analysis of 11 317 patients across clinical trials

RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000942 ◽  
Author(s):  
Jeffrey R Curtis ◽  
Xavier Mariette ◽  
Cécile Gaujoux-Viala ◽  
Andrew Blauvelt ◽  
Tore K Kvien ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Crohn’S Disease ◽  
Psoriatic Arthritis ◽  
Crohn's Disease ◽  
Axial Spondyloarthritis ◽  
Certolizumab Pegol ◽  
Major Adverse Cardiovascular Events ◽  
Expert Committee

ObjectiveTo review long-term certolizumab pegol (CZP) safety across all approved indications: rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), psoriasis (PSO) and Crohn’s disease (CD).MethodsData were pooled across 49 UCB-sponsored CZP clinical trials (27 RA, one axSpA, one PsA, five PSO, 15 CD) to August 2017. Serious adverse events (SAEs) of interest (infections, malignancies, autoimmunity/hypersensitivity events, major adverse cardiovascular events (MACE), gastrointestinal (GI) perforations, psoriasis events, laboratory abnormalities) and deaths were medically reviewed by an external expert committee, using predefined case rules. Incidence rates (IRs)/100 patient-years (PY) are presented by indication; standardised mortality and malignancy rates were calculated using WHO/GLOBOCAN/SEER databases. Pregnancies with maternal CZP exposure are also reported.ResultsOf 11 317 CZP-treated patients across indications (21 695 PY CZP exposure; maximum: 7.8 years), infections were the most common SAEs (overall IR: 3.62/100 PY; IRs ranged from 1.50/100 PY(PSO) to 5.97/100 PY(CD)). The IR for malignancies was 0.82/100 PY, including lymphoma (0.06/100 PY). MACE and GI perforation IRs in CZP-treated patients were 0.47/100 PY and 0.08/100 PY and were highest in RA and CD, respectively. Patients with PSO had the lowest SAE rates. The incidence of deaths and malignancies aligned with expected general population data.ConclusionThis extensive overview of the CZP safety profile in clinical trials, across all indications, provides large-scale confirmation of previous reports. No new safety signals or relevant non-disease-related laboratory abnormalities were identified. The study demonstrated some indication-specific differences in certain SAE rates that may be attributable to the underlying inflammatory disease.

scholarly journals Adverse Events in Patients With Rheumatoid Arthritis and Psoriatic Arthritis Receiving Long-Term Biological Agents in a Real-Life Setting

2019 ◽  
Vol 10 ◽  
Author(s):  
Mayara Costa de Camargo ◽  
Bruna Cipriano Almeida Barros ◽  
Izabela Fulone ◽  
Marcus Tolentino Silva ◽  
Miriam Sanches do Nascimento Silveira ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Real Life ◽  
Biological Agents ◽  
Real Life Setting

scholarly journals Early Monitoring of Infliximab Serum Trough Levels Predicts Long-Term Therapy Failure in Patients With Axial Spondyloarthritis

2020 ◽  
Author(s):  
Ana Martínez Feito ◽  
Victoria Navarro-Compán ◽  
Borja Hernández-Breijo ◽  
Eva Olariaga-Mérida ◽  
Diana Peiteado ◽  
...  
Keyword(s):  
Disease Activity ◽  
Clinical Improvement ◽  
Axial Spondyloarthritis ◽  
Drop Out ◽  
Term Therapy ◽  
Clinical Failure ◽  
Therapy Failure ◽  
Drug Survival ◽  
Trough Levels

Abstract Background: The aim of our study is to evaluate whether serum infliximab trough levels (ITL) during the early stages of treatment are predictive of long-term clinical failure in patients with axial spondyloarthritis (axSpA).Methods: Longitudinal observational study involving 81 patients with axSpA recruited from the SpA-Paz cohort and monitored during infliximab therapy. Serum ITL were measured at baseline, week 2 (W2), W6 and W12 of treatment. Disease activity was assessed by the Ankylosing Spondylitis Disease Activity Score (ASDAS) at baseline, W24 and W54, and every 6 months thereafter until therapy failure. Non-clinically important improvement was defined by ΔASDAS<1.1. The association between serum ITL levels at W12 and clinical outcomes (non-improvement at W52, drug survival and drop-out due to secondary inefficacy) was investigated through logistic regression models and Kaplan Meier curves. Receiver operating characteristic (ROC) curves were employed to determine the best cut-off for serum ITL. Results: Out of the 81 patients, 45 (56%) did not achieve clinical improvement at W52. These patients had lower serum ITL at W12 compared to those who improved: ITL [median (IQR)]: 4.1(0.9-8.3) µg/ml vs 7.1(4.3-11.3)µg/ml, respectively; p=0.007). A cut-off of ITL<6.7µg/mL at W12 was significantly associated with: i) not achieving clinical improvement at W52 (OR: 2.3; 95%CI: 1.3-3.9); ii) shorter drug survival (5.0 years (95% CI: 3.8-6.2) vs 7.6 years (95% CI: 4.8-6.9); p=0.04); and iii) higher drop-out rates due to secondary inefficacy (OR: 3.5; 95%CI: 1.2-10.2). Conclusions: Serum ITL<6.7 µg/mL at W12 were associated with long-term clinical failure in patients with axSpA, especially due to secondary inefficacy.

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