Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: Findings of a fifty‐two–week, phase III, multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group study

Abstract

Objective. To evaluate the efficacy and safety of 2 dosage regimens of lyophilized certolizumab pegol (a novel PEGylated anti-tumor necrosis factor agent) as adjunctive therapy to methotrexate (MTX) in patients with active rheumatoid arthritis (RA) with an inadequate response to MTX therapy alone.Methods. In this 52-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallelgroup trial, 982 patients were randomized 2:2:1 to receive treatment with subcutaneous certolizumab pegol at an initial dosage of 400 mg given at weeks 0, 2, and 4, with a subsequent dosage of 200 mg or 400 mg given every 2 weeks, plus MTX, or placebo plus MTX. Coprimary end points were the response rate at week 24 according to the American College of Rheumatology 20% criteria for improvement (ACR20) and the mean change from baseline in the modified total Sharp score at week 52.Results. At week 24, ACR20 response rates using ClinicalTrials.gov identifier: NCT00152386.

Transferrin-functionalized nanoparticles lose their targeting capabilities when a biomolecule corona adsorbs on the surface

“…Nanoparticles have been proposed as carriers for drugs, genes and therapies to treat various diseases 1 The potential of targeting nanomedicines has already been illustrated in practice [5][6][7] . Among these general approaches, the role of nanomedicines exploiting active targeting via specific ligands is increasing in prominence [8][9][10] .…”

“…Among these general approaches, the role of nanomedicines exploiting active targeting via specific ligands is increasing in prominence [8][9][10] . These efforts have met with varying success [5][6][7] , and it is not always possible to fully explain the different outcomes. Likely, there are several reasons for this 2,9,11,12 , but certainly there remains a lack of detailed mechanistic information on the link between nanoparticle surface and biological interactions.…”

“…The approaches outlined here may be of general value in such studies, and possibly shed some light on factors rendering some targeting studies more promising than others [5][6][7] .…”

Generalization and Extrapolation of Treatment Effects From Clinical Studies in Rheumatoid Arthritis

“…The effect of glucocorticoid treatment at baseline might be an indicator of disease activity, or the treatment itself might be of additional value, like cotreatment with a DMARD (33,34,40,42,43).…”

New Treatment Alternatives in the Management of Non-İnfectious İntraocular İnflammations: Biologic Agents

“…54 Literatürde bu ajan en çok Crohn hastal›¤› ve RA üzerinde araflt›r›lm›flt›r ve her iki tabloda da etkili oldu¤unu bildiren yay›nlar mevcuttur. 57,58 3. Di¤er Biyolojik Ajanlar Daclizumab Daclizumab (Zenapax ® ), baflta aktif T hücreleri olmak üzere immün sistemdeki hücreler üzerinde bulunan, IL-2 reseptörü üzerinde bulunan alfa alt-unitesi (CD25)'ne karfl› gelifltirilmifl bir monoklonal antikordur.…”