Correction to: Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents.

The article Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents, written by Vibeke Strand, Joao Gonçalves, Timothy P. Hickling, Heather E. Jones, Lisa Marshall and John D.

Immunogenicity of Biosimilars for Rheumatic Diseases, Plaque Psoriasis, and Inflammatory Bowel Disease: A Review from Clinical Trials and Regulatory Documents.

The goal of this narrative review was to summarize immunogenicity data of biosimilars or biosimilar candidates for rheumatic diseases, plaque psoriasis, or inflammatory bowel disease (IBD), available in peer-reviewed publications or regulatory documents. PubMed records and regulatory documents were searched for immunogenicity data of TNFα or CD20 inhibitor biosimilars or biosimilar candidates. Data collected included the proportion of patients positive for anti-drug antibodies (ADAbs), proportion with neutralizing antibodies (nAbs) among ADAb-positive patients, ADAb/nAb assay characteristics, cross-reactivity, and the effects of ADAbs on pharmacokinetics, pharmacodynamics, efficacy, and safety.

Does psoriatic axial spondyloarthritis phenotype correlate with imaging morphotype?

Objectives: To compare the magnetic resonance imaging (MRI) morphology of inflammatory and chronic lesions in the sacroiliac joints (SIJs) and spine between patients with non-psoriatic and psoriatic non-radiographic axial spondyloarthritis (axSpA and p-axSpA, respectively).

Methods: Patients from the EMBARK trial (NCT01258738) with axSpA (n=179) and p-axSpA (n=24) who had MRI data available were compared in terms of baseline demographics, clinical characteristics, and the frequency (n/N [%]) and distribution of inflammatory and structural SIJ and spinal lesions.

Results: Patients with p-axSpA were on average older (35.

Longterm Drug Survival of Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis.

Objective: To evaluate longterm drug survival (proportion of patients still receiving treatment) and discontinuation of etanercept (ETN), infliximab (IFX), adalimumab (ADA), certolizumab pegol (CZP), and golimumab (GOL) using observational data from patients with rheumatoid arthritis (RA).

Methods: Following a systematic literature review, drug survival at 12 and 12-24 months of followup was estimated by summing proportions of patients continuing treatment and dividing by number of studies. Drug survival at ≥ 36 months of followup was estimated through Metaprop.

Practical Guidance on Biosimilars, With a Focus on Latin America: What Do Rheumatologists Need to Know?

Background/historical Perspective: Availability of biologic disease-modifying antirheumatic drugs (bDMARDs) has improved clinical outcomes in rheumatoid arthritis, but it also increased the cost of treatment. Biosimilars, the regulated copies of biologic products, have a potential to reduce health care costs and expand access to treatment. However, because of a complex development process, biosimilars can be considered only those noninnovator biologics with satisfactory supporting evidence (ranging from structural to clinical), as outlined in the recommendations by the World Health Organization (WHO).

Maintenance of Remission with Etanercept-DMARD Combination Therapy Compared with DMARDs Alone in African and Middle Eastern Patients with Active Rheumatoid Arthritis.

Introduction: To compare etanercept (ETN) and placebo (PBO) for maintaining low disease activity (LDA) achieved with ETN in patients with rheumatoid arthritis (RA) from Africa and the Middle East.

Methods: In this subset analysis of the Treat-to-Target trial (ClinicalTrials.gov identifier NCT01981473), 53 adult patients with moderate-to-severe RA nonresponsive to methotrexate were treated with 50 mg ETN/week for 24 weeks (Period 1).

Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis.

Objective: To compare 2 years of radiographic sacroiliac joint (SIJ) changes in patients with recent onset axial spondyloarthritis (axSpA) receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR).

Methods: Endpoints were changes at week 104 per the modified New York (mNY) grading system in total SIJ score (primary endpoint) and net percentage of patients with progression defined three ways. Treatment effect was analysed with and without adjustment for baseline covariates.

Modification of structural lesions on MRI of the sacroiliac joints by etanercept in the EMBARK trial: a 12-week randomised placebo-controlled trial in patients with non-radiographic axial spondyloarthritis.

Objective: To evaluate the impact on structural lesions observed on MRI in the sacroiliac joints (SIJ) at 12 weeks in patients with non-radiographic axial spondyloarthritis (nr-axSpA) receiving etanercept or placebo in EMBARK (Effect of Etanercept on Symptoms and Objective Inflammation in nr-axSpA, a 104 week study).

Methods: Patients were randomised to double-blind etanercept 50 mg/week or placebo for 12 weeks. Structural lesions at baseline and 12 weeks were scored by two independent readers using the Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ structural score (SSS) on T1-weighted MRI.

A Pilot Dose-Finding Study of Etanercept in Rheumatoid Arthritis.

A randomized, parallel-dose study assessed the pharmacokinetics (PK) and pharmacodynamics (PD) of etanercept in 61 patients with rheumatoid arthritis (RA) who received doses from 10 mg once-weekly to 50 mg twice-weekly for 4 weeks. Empiric application of a maximal-effect (E ) model to pooled steady-state concentrations (C ) and PD markers provided half-maximal-effect concentration estimates of 567, 573, 465, 87, and 159 ng/mL for change from baseline in number of swollen joints, number of painful joints, erythrocyte sedimentation rate, interleukin-6, and matrix metalloproteinase-3, respectively. C >∼2,000 ng/mL did not appear to offer additional benefit.