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Certolizumab pegol

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https://www.readbyqxmd.com/read/28523420/cost-utility-analysis-of-certolizumab-pegol-in-combination-with-methotrexate-in-patients-with-moderate-to-severe-active-rheumatoid-arthritis-in-greece
#1
C Tzanetakos, A Tzioufas, A Goules, G Kourlaba, T Theodoratou, P Christou, N Maniadakis
We aimed to evaluate the cost-effectiveness of certolizumab pegol (CZP), a pegylated fc-free anti-TNF, as add-on therapy to methotrexate (MTX) versus etanercept, adalimumab, or golimumab in patients with moderate-to-severe active rheumatoid arthritis (RA) not responding to the conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). A Markov model (6-month cycle length) assessed health and cost outcomes of CZP versus other anti-TNFs recommended for RA in Greece over a patient's lifetime. Following discontinuation of first-line anti-TNF, patients switched to second anti-TNF and then to a biologic with another mode of action...
May 18, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28498975/sustained-efficacy-safety-and-patient-reported-outcomes-of-certolizumab-pegol-in-axial-spondyloarthritis-4-year-outcomes-from-rapid-axspa
#2
Désirée van der Heijde, Maxime Dougados, Robert Landewé, Joachim Sieper, Walter P Maksymowych, Martin Rudwaleit, Filip Van den Bosch, Jürgen Braun, Philip J Mease, Alan J Kivitz, Jessica Walsh, Owen Davies, Lars Bauer, Bengt Hoepken, Luke Peterson, Atul Deodhar
Objective.: The aim was to assess the long-term safety and efficacy of certolizumab pegol over 4 years of continuous treatment in patients with axial spondyloarthritis (axSpA), including both AS and non-radiographic (nr-) axSpA. Methods.: RAPID-axSpA was a phase 3 randomized trial, double blind and placebo controlled to week 24, dose blind to week 48 and open label to week 204. Patients had a clinical diagnosis of axSpA, meeting Assessment of SpondyloArthritis international Society (ASAS) criteria, and had active disease...
May 12, 2017: Rheumatology
https://www.readbyqxmd.com/read/28483767/incidence-and-prevalence-of-psoriatic-arthritis-in-denmark-a-nationwide-register-linkage-study
#3
Alexander Egeberg, Lars Erik Kristensen, Jacob P Thyssen, Gunnar Hilmar Gislason, Alice B Gottlieb, Laura C Coates, Denis Jullien, Paolo Gisondi, Dafna D Gladman, Lone Skov, Lotus Mallbris
OBJECTIVES: To examine the incidence and temporal trends of psoriatic arthritis (PsA) in the general population in Denmark. METHODS: Using nationwide registry data, we estimated the number of patients with incident PsA within each 1-year period between 1997 and 2011 and calculated the rate of PsA cases within gender and age subgroups. Incidence rates were presented per 100 000 person-years. RESULTS: There was a female predominance ranging from 50...
May 8, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28481462/biologics-or-tofacitinib-for-people-with-rheumatoid-arthritis-naive-to-methotrexate-a-systematic-review-and-network-meta-analysis
#4
REVIEW
Jasvinder A Singh, Alomgir Hossain, Amy S Mudano, Elizabeth Tanjong Ghogomu, Maria E Suarez-Almazor, Rachelle Buchbinder, Lara J Maxwell, Peter Tugwell, George A Wells
BACKGROUND: Biologic disease-modifying anti-rheumatic drugs (biologics) are highly effective in treating rheumatoid arthritis (RA), however there are few head-to-head biologic comparison studies. We performed a systematic review, a standard meta-analysis and a network meta-analysis (NMA) to update the 2009 Cochrane Overview. This review is focused on the adults with RA who are naive to methotrexate (MTX) that is, receiving their first disease-modifying agent. OBJECTIVES: To compare the benefits and harms of biologics (abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab) and small molecule tofacitinib versus comparator (methotrexate (MTX)/other DMARDs) in people with RA who are naive to methotrexate...
May 8, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28452862/anti-tnf-treatment-for-extraintestinal-manifestations-of-inflammatory-bowel-disease-in-the-swiss-ibd-cohort-study
#5
Stephan R Vavricka, Martin Gubler, Claudine Gantenbein, Muriel Spoerri, Florian Froehlich, Frank Seibold, Marijana Protic, Pierre Michetti, Alex Straumann, Nicolas Fournier, Pascal Juillerat, Luc Biedermann, Jonas Zeitz, Benjamin Misselwitz, Michael Scharl, Henriette Heinrich, Christine N Manser, Ekaterina Safroneeva, Raja Affendi Raja Ali, Gerhard Rogler, Alain M Schoepfer, Thomas Greuter
BACKGROUND: Extraintestinal manifestations (EIMs) in patients with inflammatory bowel disease (IBD) are frequently observed. Little is known about the efficacy of anti-tumor necrosis factor (TNF) in EIM management. We assessed the effect of 3 anti-TNF agents (infliximab, adalimumab, and certolizumab pegol) on EIM evolution. METHODS: Data on 1249 patients from the Swiss IBD Cohort Study (SIBDCS) were analyzed. All EIMs were diagnosed by relevant specialists. Response was classified into improvement, stable disease, and clinical worsening based on the physician's interpretation...
April 27, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28410817/medication-adherence-and-persistence-over-time-with-self-administered-tnf-alpha-inhibitors-among-young-adult-middle-aged-and-older-patients-with-rheumatologic-conditions
#6
Gregory S Calip, Sruthi Adimadhyam, Shan Xing, Julian C Rincon, Wan-Ju Lee, Rebekah H Anguiano
OBJECTIVE: Self-injectable TNF inhibitors are increasingly used early in the chronic treatment of moderate to severe rheumatologic conditions. We estimated medication adherence/persistence over time following initiation in young adult and older adult patients with rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis. METHODS: We conducted a retrospective cohort study of patients aged 18+ years newly initiating etanercept, adalimumab, certolizumab pegol, or golimumab using the Truven Health MarketScan Database between 2009 and 2013...
March 21, 2017: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/28410341/effects-of-transient-and-persistent-anti-drug-antibodies-to-certolizumab-pegol-longitudinal-data-from-a-7-year-study-in-crohn-s-disease
#7
William J Sandborn, Douglas C Wolf, Gordana Kosutic, Gerry Parker, Stefan Schreiber, Scott D Lee, Bincy Abraham, Anita Afzali, Razvan I Arsenescu, Alexandra Gutierrez, Marshall Spearman, Jason Coarse, Brian G Feagan
BACKGROUND: Anti-drug antibodies (ADAbs) may decrease the efficacy of biologics and increase the risk of adverse events. A single positive test may not preclude further treatment because of variations in assays used, test timing, and patient variables. We evaluated the longitudinal patterns of immunogenicity during 7 years of antitumor necrosis factor-alpha drug certolizumab pegol (CZP) treatment for moderate-to-severe Crohn's disease. METHODS: PRECiSE 3 patients (n = 595) received open-label CZP 400 mg every 4 weeks up to 7 years...
April 13, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28405087/leukocytoclastic-vasculitis-drug-reaction-to-certolizumab-pegol
#8
Meghan Woody, Donald Warren, Laura Speck, Julie Jackson
Tumor necrosis factor (TNF)-alpha antagonists are a common treatment modality for autoimmune disorders, but their use can be associated with many side effects, including various dermatologic conditions. Certolizumab pegol, a newer TNF antagonist that lacks the Fc portion of the IgG antibody, has recently been approved to treat psoriatic arthritis, rheumatoid arthritis, and Crohn's disease. Though other TNF antagonists have been associated with leukocytoclastic vasculitis, this finding has not yet been reported with certolizumab pegol...
April 2017: Proceedings of the Baylor University Medical Center
https://www.readbyqxmd.com/read/28376912/head-to-head-comparison-of-aggressive-conventional-therapy-and-three-biological-treatments-and-comparison-of-two-de-escalation-strategies-in-patients-who-respond-to-treatment-study-protocol-for-a-multicenter-randomized-open-label-blinded-assessor-phase-4-study
#9
Daniel Glinatsi, Marte S Heiberg, Anna Rudin, Dan Nordström, Espen A Haavardsholm, Bjorn Gudbjornsson, Mikkel Østergaard, Till Uhlig, Gerdur Grondal, Kim Hørslev-Petersen, Ronald van Vollenhoven, Merete L Hetland
BACKGROUND: New targeted therapies and improved treatment strategies have dramatically improved the outcomes of patients with rheumatoid arthritis (RA). However, it is unknown whether different early aggressive interventions can induce stable remission or a low-active disease state that can be maintained with conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy, and whether they differ in efficacy and safety. The Nordic Rheumatic Diseases Strategy Trials And Registries (NORD-STAR) study will assess and compare (1) the proportion of patients who achieve remission in a head-to-head comparison between csDMARD plus glucocorticoid therapy and three different biological DMARD (bDMARD) therapies with different modes of action and (2) two de-escalation strategies in patients who respond to first-line therapy...
April 4, 2017: Trials
https://www.readbyqxmd.com/read/28353191/long-term-maintenance-of-certolizumab-pegol-safety-and-efficacy-in-combination-with-methotrexate-and-as-monotherapy-in-rheumatoid-arthritis-patients
#10
Roy Fleischmann, Ronald F van Vollenhoven, Jiri Vencovský, Rieke Alten, Owen Davies, Irina Mountian, Marc de Longueville, David Carter, Ernest Choy
INTRODUCTION: The safety and efficacy of certolizumab pegol (CZP) 400 mg every 4 weeks (Q4W) monotherapy (FAST4WARD/NCT00548834) and in combination with methotrexate (MTX) (014/NCT00544154) in active rheumatoid arthritis (RA) has been published previously. This report outlines final long-term outcomes from the open-label extension (OLE) study (015/NCT00160693), which enrolled patients from these randomized controlled trials (RCTs). METHODS: Patients who withdrew from or completed the 24-week 014/FAST4WARD RCTs were enrolled and received CZP 400 mg Q4W with/without MTX...
March 28, 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/28353055/accounting-for-pharmacokinetic-variability-of-certolizumab-pegol-in-patients-with-crohn-s-disease
#11
Niels Vande Casteele, Diane R Mould, Jason Coarse, Iram Hasan, Ann Gils, Brian Feagan, William J Sandborn
BACKGROUND: Certolizumab pegol is an effective biologic for patients with Crohn's disease (CD). Individual differences in certolizumab pegol apparent clearance (CL/F) affect exposure and possibly efficacy. A previously developed population pharmacokinetic (PK) model did not account for dynamic changes in clinical parameters during therapy. OBJECTIVE: The aim of this study was to refine the existing PK model to capture the time-varying influence of covariates. METHODS: Data collected from 2157 Crohn's disease patients in nine studies were analyzed using nonlinear mixed-effects modeling software (NONMEM)...
March 28, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28336735/risk-of-tuberculosis-in-patients-treated-with-tnf-%C3%AE-antagonists-a-systematic-review-and-meta-analysis-of-randomised-controlled-trials
#12
Zheng Zhang, Wei Fan, Gui Yang, Zhigao Xu, June Wang, Qingyuan Cheng, Mingxia Yu
OBJECTIVES: An increased risk of tuberculosis (TB) has been reported in patients treated with TNF-α antagonists, an issue that has been highlighted in a WHO black box warning. This review aimed to assess the risk of TB in patients undergoing TNF-α antagonists treatment. METHODS: A systematic literature search for randomised controlled trials (RCTs) was performed in MEDLINE, Embase and Cochrane library and studies selected for inclusion according to predefined criteria...
March 22, 2017: BMJ Open
https://www.readbyqxmd.com/read/28282491/biologics-or-tofacitinib-for-people-with-rheumatoid-arthritis-unsuccessfully-treated-with-biologics-a-systematic-review-and-network-meta-analysis
#13
REVIEW
Jasvinder A Singh, Alomgir Hossain, Elizabeth Tanjong Ghogomu, Amy S Mudano, Lara J Maxwell, Rachelle Buchbinder, Maria Angeles Lopez-Olivo, Maria E Suarez-Almazor, Peter Tugwell, George A Wells
BACKGROUND: Biologic disease-modifying anti-rheumatic drugs (DMARDs: referred to as biologics) are effective in treating rheumatoid arthritis (RA), however there are few head-to-head comparison studies. Our systematic review, standard meta-analysis and network meta-analysis (NMA) updates the 2009 Cochrane overview, 'Biologics for rheumatoid arthritis (RA)' and adds new data. This review is focused on biologic or tofacitinib therapy in people with RA who had previously been treated unsuccessfully with biologics...
March 10, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28280401/review-of-the-treatment-of-psoriatic-arthritis-with-biological-agents-choice-of-drug-for-initial-therapy-and-switch-therapy-for-non-responders
#14
REVIEW
Salvatore D'Angelo, Giuseppina Tramontano, Michele Gilio, Pietro Leccese, Ignazio Olivieri
Psoriatic arthritis (PsA) is a heterogeneous chronic inflammatory disease with a broad clinical spectrum and variable course. It can involve musculoskeletal structures as well as skin, nails, eyes, and gut. The management of PsA has changed tremendously in the last decade, thanks to an earlier diagnosis, an advancement in pharmacological therapies, and a wider application of a multidisciplinary approach. The commercialization of tumor necrosis factor inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, and infliximab) as well as interleukin (IL)-12/23 (ustekinumab) and IL-17 (secukinumab) inhibitors is representative of a revolution in the treatment of PsA...
2017: Open Access Rheumatology: Research and Reviews
https://www.readbyqxmd.com/read/28275925/systematic-review-with-meta-analysis-loss-of-response-and-requirement-of-anti-tnf%C3%AE-dose-intensification-in-crohn-s-disease
#15
REVIEW
Yun Qiu, Bai-Li Chen, Ren Mao, Sheng-Hong Zhang, Yao He, Zhi-Rong Zeng, Shomron Ben-Horin, Min-Hu Chen
BACKGROUND: To review the frequency with which anti-TNF-α loses its effect and dose "intensification" is required for Crohn's disease (CD) treatment. METHODS: Electronic databases were searched for eligible studies. Raw data from studies meeting inclusion criteria were pooled for effect estimates. Subgroup analyses were performed for exploration of heterogeneity regarding all outcomes. RESULTS: Eighty-six eligible studies were included. Estimates of loss of response (LOR) incidence ranged from 8 to 71%...
May 2017: Journal of Gastroenterology
https://www.readbyqxmd.com/read/28264816/eular-recommendations-for-the-management-of-rheumatoid-arthritis-with-synthetic-and-biological-disease-modifying-antirheumatic-drugs-2016-update
#16
Josef S Smolen, Robert Landewé, Johannes Bijlsma, Gerd Burmester, Katerina Chatzidionysiou, Maxime Dougados, Jackie Nam, Sofia Ramiro, Marieke Voshaar, Ronald van Vollenhoven, Daniel Aletaha, Martin Aringer, Maarten Boers, Chris D Buckley, Frank Buttgereit, Vivian Bykerk, Mario Cardiel, Bernard Combe, Maurizio Cutolo, Yvonne van Eijk-Hustings, Paul Emery, Axel Finckh, Cem Gabay, Juan Gomez-Reino, Laure Gossec, Jacques-Eric Gottenberg, Johanna M W Hazes, Tom Huizinga, Meghna Jani, Dmitry Karateev, Marios Kouloumas, Tore Kvien, Zhanguo Li, Xavier Mariette, Iain McInnes, Eduardo Mysler, Peter Nash, Karel Pavelka, Gyula Poór, Christophe Richez, Piet van Riel, Andrea Rubbert-Roth, Kenneth Saag, Jose da Silva, Tanja Stamm, Tsutomu Takeuchi, René Westhovens, Maarten de Wit, Désirée van der Heijde
Recent insights in rheumatoid arthritis (RA) necessitated updating the European League Against Rheumatism (EULAR) RA management recommendations. A large international Task Force based decisions on evidence from 3 systematic literature reviews, developing 4 overarching principles and 12 recommendations (vs 3 and 14, respectively, in 2013). The recommendations address conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) (methotrexate (MTX), leflunomide, sulfasalazine); glucocorticoids (GC); biological (b) DMARDs (tumour necrosis factor (TNF)-inhibitors (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, rituximab, tocilizumab, clazakizumab, sarilumab and sirukumab and biosimilar (bs) DMARDs) and targeted synthetic (ts) DMARDs (Janus kinase (Jak) inhibitors tofacitinib, baricitinib)...
June 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28214596/early-non-response-to-certolizumab-pegol-in-rheumatoid-arthritis-predicts-treatment-failure-at-one-year-data-from-a-randomised-phase-iii-clinical-trial
#17
Francis Berenbaum, Thao Pham, Pascal Claudepierre, Thibault de Chalus, Jean-Michel Joubert, Carine Saadoun, Lionel Riou França, Bruno Fautrel
OBJECTIVES: To compare different early clinical criteria of non-response determined at three months as predictors of clinical failure at one year in patients with rheumatoid arthritis starting therapy with certolizumab pegol. METHODS: Data were derived from a randomised Phase III clinical trial in patients with rheumatoid arthritis who failed to respond to methotrexate monotherapy. Patients included in this post-hoc analysis were treated with certolizumab pegol (400mg qd reduced to 200mg qd after one month) and with methotrexate...
February 16, 2017: Joint, Bone, Spine: Revue du Rhumatisme
https://www.readbyqxmd.com/read/28165828/certolizumab-pegol-for-the-treatment-of-psoriasis
#18
A Campanati, D Benfaremo, M M Luchetti, G Ganzetti, A Gabrielli, A Offidani
Psoriasis is a chronic immunomediated and inflammatory disease involving mainly skin and joints, often associated with several metabolic and non-metabolic comorbidities. TNF-alpha inhibitors have shown long-term efficacy and safety/tolerability in psoriasis, and preliminary data support the use of certolizumab pegol (CZP) as well. Areas covered: The authors review the pharmacological properties of CZP, as well as its safety data and efficacy profile. They also review the quality of life outcomes related to CZP in psoriasis...
February 6, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28158970/tumor-necrosis-factor-alpha-inhibitors-have-no-effect-on-a-human-t-lymphotropic-virus-type-i-htlv-i-infected-cell-line-from-patients-with-htlv-i-associated-myelopathy
#19
Shoichi Fukui, Hideki Nakamura, Yoshiko Takahashi, Naoki Iwamoto, Hiroo Hasegawa, Katsunori Yanagihara, Tatsufumi Nakamura, Akihiko Okayama, Atsushi Kawakami
BACKGROUND: While tumor necrosis factor alpha (TNF-α) inhibitors (TNFi) and other biologics are very effective against autoimmune diseases, they can also cause infectious diseases. Therefore, it is important to clarify whether the TNFi sometimes used to treat patients with rheumatoid arthritis (RA) complicated with human T-lymphotropic virus type-I (HTLV-I) infection have the unintended side effect of promoting HTLV-I proliferation. METHODS: We used the HTLV-I-infected cell line HCT-5, derived from spinal fluid cells of a patient with HTLV-I associated myelopathy, to evaluate the production of cytokines and chemokines, TNF-α receptor (TNFR), the expression of HTLV-I associated genes, the HTLV-I proviral load (PVL), the expression of HTLV-I structural protein, and apoptosis...
February 3, 2017: BMC Immunology
https://www.readbyqxmd.com/read/28153828/clinical-benefit-of-1-year-certolizumab-pegol-czp-add-on-therapy-to-methotrexate-treatment-in-patients-with-early-rheumatoid-arthritis-was-observed-following-czp-discontinuation-2-year-results-of-the-c-opera-study-a-phase-iii-randomised-trial
#20
Tatsuya Atsumi, Yoshiya Tanaka, Kazuhiko Yamamoto, Tsutomu Takeuchi, Hisashi Yamanaka, Naoki Ishiguro, Katsumi Eguchi, Akira Watanabe, Hideki Origasa, Shinsuke Yasuda, Yuji Yamanishi, Yasuhiko Kita, Tsukasa Matsubara, Masahiro Iwamoto, Toshiharu Shoji, Osamu Togo, Toshiyuki Okada, Désirée van der Heijde, Nobuyuki Miyasaka, Takao Koike
OBJECTIVES: To investigate the clinical impact of 1-year certolizumab pegol (CZP) therapy added to the first year of 2-year methotrexate (MTX) therapy, compared with 2-year therapy with MTX alone. METHODS: MTX-naïve patients with early rheumatoid arthritis (RA) with poor prognostic factors were eligible to enter Certolizumab-Optimal Prevention of joint damage for Early RA (C-OPERA), a multicentre, randomised, controlled study, which consisted of a 52-week double-blind (DB) period and subsequent 52-week post treatment (PT) period...
February 2, 2017: Annals of the Rheumatic Diseases
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