
DOI . ORG {
}
Title[redir]:
One-year Efficacy and Safety Results of Secukinumab in Patients With Rheumatoid Arthritis: Phase II, Dose-finding, Double-blind, Randomized, Placebo-controlled Study | The Journal of Rheumatology
Description:
Objective. To evaluate the longer-term safety and efficacy of secukinumab, a fully human monoclonal antiinterleukin-17A antibody, in patients with rheumatoid arthritis. Methods. In this 52-week, double-blind, placebo-controlled (up to Week 20) study ([NCT00928512][1]), patients responding inadequately to disease-modifying antirheumatic drugs (DMARD) or biologics were randomized to receive monthly subcutaneous injections of secukinumab (25, 75, 150, or 300 mg), or placebo. The efficacy and safety results up to Week 20 have been reported previously. Here, efficacy results from Week 20 to 52 and safety results from Week 20 to 60 are presented. Results. Of 237 patients randomized, 174 (73.4%) completed the study. Patients with improved American College of Rheumatology (ACR) and 28-joint Disease Activity Score (DAS28) C-reactive protein (CRP) responses at Week 16 sustained their responses through Week 52. In patients taking 150 mg of secukinumab, responses were improved through Week 52 (ACR50: Week 16 = 45%, Week 52 = 55%; DAS28-CRP โค 2.6: Week 16 = 25%, Week 52 = 40%). The rate of adverse events (AE) from weeks 20 to 60 was 64.8%, with most AE being mild to moderate in severity. The overall rate of infections was 31.9%, most being mild. The most predominant infection was nasopharyngitis, and was not associated with dose or concurrent neutropenia. Serious AE were reported in 21 patients (8.9%). There were 3 reports of malignancies (ovarian, lung, basal cell), and no deaths between weeks 20 and 60. Conclusion. Patients with active RA who failed to respond to DMARD and other biologics showed an improvement after longterm treatment with 150 mg of secukinumab. The frequency of AE remained stable over time and secukinumab had a consistent safety profile over 60 weeks. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00928512&atom=%2Fjrheum%2F41%2F3%2F414.atom
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Keywords {๐}
week, patients, secukinumab, study, scholar, arthritis, treatment, acr, safety, dose, efficacy, weeks, response, rheumatoid, placebo, taking, openurlcrossrefpubmedgoogle, results, randomized, biologics, figure, phase, time, full, reported, infections, doubleblind, rheumatology, disease, jrheum, placebocontrolled, responses, achieving, textgoogle, crp, active, improvement, ila, nonresponders, set, groups, therapeutic, observed, openurlabstractfree, rheum, follow, antibody, activity, sustained, autoimmune,
Topics {โ๏ธ}
cyclosporin a-sensitive mechanism disease-modifying antirheumatic drugs human monoclonal antibody fully human antibody discussion results validating il-17a neutralization c-reactive protein references 1 footnotes supported il-17/il-17 receptor system selectively neutralizes il-17a author editorial board methods study design specific organ class article jump dose-dependent adverse effects rss research articlearticle acknowledgment print issn placebo-controlled study mark antagonizing rorฮณt activity autoimmune disease neutrophils release il-17 rheumatology resources guide receive subcutaneous injections key inclusion criteria key exclusion criteria secukinumab-treated groups based key indexing terms full analysis set health care professionals urinary tract infections washout period ranging il-17a receptor autoimmune arthritis secukinumab related twelve-month results il-17a appears sang-heon lee unknown etiology characterized logistic regression model imputing missing values klebsiella pneumonia bacteremia high-density lipoprotein low-density lipoprotein white blood cells novartis pharmaceutical corporation novartis healthcare pvt novartis pharma ag synovial endothelial cells
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