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https://www.readbyqxmd.com/read/28629289/mania-induced-by-adalimumab-in-a-patient-with-ankylosing-spondylitis
#1
Elias Ghossoub, Mohamad Habli, Imad Uthman, Fadi T Maalouf
Objectives Monoclonal antibodies such as antagonists of tumor necrosis factor-alpha have been shown to have beneficial effects on the well-being of patients with inflammatory illnesses. However, mood episodes triggered by such agents have been reported. We herein report the case of mania induced by adalimumab treatment in an adult with ankylosing spondylitis, which later resolved once adalimumab was discontinued and mood stabilizers were initiated. Methods A 25-year-old man, with prior history of dysthymia, was diagnosed with ankylosing spondylitis and started on adalimumab...
August 2016: International Journal of Psychiatry in Medicine
https://www.readbyqxmd.com/read/28598787/severe-adverse-drug-reactions-to-biological-disease-modifying-anti-rheumatic-drugs-in-elderly-patients-with-rheumatoid-arthritis-in-clinical-practice
#2
Leticia Leon, Alejandro Gomez, Cristina Vadillo, Esperanza Pato, Luis Rodriguez-Rodriguez, Juan Angel Jover, Lydia Abasolo
OBJECTIVES: Biological DMARDs are widely used in the treatment of rheumatoid arthritis (RA) but their relationship with adverse drug reaction (ADR) is important. RA is now known to increase in incidence and prevalence with age. Our objective was to assess the incidence of severe ADR in the long term, compare safety between the different bDMARDs and identify other possible risk factors for severe ADR in elderly RA patients. METHODS: A 14-year retrospective longitudinal study was performed...
June 6, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28597181/clinical-signs-pathophysiology-and-management-of-cutaneous-side-effects-of-anti-tumor-necrosis-factor-agents
#3
REVIEW
Siegfried Segaert, Caroline Hermans
Approximately one in four patients treated with anti-TNF agents (infliximab, etanercept, adalimumab, certolizumab, and golimumab) develops cutaneous adverse events, typically months to years after the initiation of treatment, with xerosis cutis, eczema (often psoriasiform), psoriasis, palmoplantar pustulosis, cutaneous infections, alopecia, and skin cancer being the most frequently encountered. The typical skin lesion of anti-tumor necrosis factor (TNF)-treated patients is orange-red psoriasiform eczema affecting the flexures, genitalia, scalp, or face, with high susceptibility to bacterial superinfection with Staphylococcus aureus...
June 8, 2017: American Journal of Clinical Dermatology
https://www.readbyqxmd.com/read/28595194/long-term-effiicacy-and-safety-of-certolizumab-pegol-in-an-unselected-crohn-s-disease-population-the-facts-iii-survey
#4
Stephan R Vavricka, Milos Spasojevic, Gerhard Rogler, Alain M Schoepfer, Frank Seibold, Jan Borovicka, Pascal Frei, Jonas Zeitz, Thomas Greuter, Christine Manser, Michael Scharl, Benjamin Misselwitz, Alex Straumann, Pierre Michetti, Luc Biedermann
BACKGROUND: Long-term data of certolizumab pegol (CZP) in Crohn's disease (CD) from pivotal registry trials are limited. We therefore aimed to evaluate the long-term efficacy of CZP in clinical practice in Switzerland. METHODS: In the First Approved Certolizumab Therapeutic Experience in Switzerland-III phase IV multicenter cohort, patients receiving CZP were prospectively included all over Switzerland in (non-) academic hospitals and private practice. RESULTS: We included 104 CD patients (52 male; only 22...
June 9, 2017: Digestive Diseases
https://www.readbyqxmd.com/read/28589389/-safety-and-efficacy-of-off-label-use-of-biologic-therapies-in-patients-with-inflammatory-rheumatic-diseases-refractory-to-standard-of-care-therapy-data-from-a%C3%A2-nationwide-german-registry-graid2
#5
F Proft, H Schulze-Koops, M Grunke, E Schrezenmeier, F Halleck, J Henes, L Unger, E Schmidt, C Fiehn, A Jacobi, C Iking-Konert, C Kneitz, R E Schmidt, B Bannert, R E Voll, R Fischer-Betz, I Kötter, H P Tony, J Holle, M Aringer, A Erler, F Behrens, G R Burmester, T Dörner
BACKGROUND: The German Registry of Autoimmune Diseases 2 (GRAID2) is a retrospective, non-interventional, multicenter registry study collecting data from patients with inflammatory, mainly rheumatic diseases refractory to standard of care therapy and treated with an off-label biologic therapy. The retrospective documentation comprised case history, diagnosis, course of disease (including safety and global efficacy). The objective was to evaluate the global clinical outcome and safety of off-label biologic therapy in clinical practice...
June 6, 2017: Zeitschrift Für Rheumatologie
https://www.readbyqxmd.com/read/28583061/infection-after-total-knee-arthroplasty-by-m-catarrhalis-associated-with-rheumatoid-arthritis-and-dmards-therapy
#6
Perry Evangelista, Gregory Evangelista, Lauren Ogrich
Moraxella catarrhalis is not commonly associated with prosthetic joint infection (PJI). We present the first case of a patient with rheumatoid arthritis on certolizumab, an antitumor necrosis factor therapy, who developed PJI following a total knee replacement.
April 2017: Bulletin of the Hospital for Joint Diseases
https://www.readbyqxmd.com/read/28551823/indirect-comparisons-of-the-efficacy-of-biological-agents-in-patients-with-active-ankylosing-spondylitis-a-systematic-review-and-meta-analysis
#7
Patompong Ungprasert, Patricia J Erwin, Matthew J Koster
Patients with ankylosing (AS) often do not have a satisfactory response to, or could not tolerate, non-steroidal anti-inflammatory drugs (NSAIDs). Several biologic agents are available for such patients. However, the comparative efficacy of these treatments remains unknown as head-to-head randomized controlled trials (RCTs) are not available. RCTs examining the efficacy of biologic agents in patients with AS who had inadequate response to, or could not tolerate, NSAIDs were identified. If at least two RCTs were available for a given biologic agent, the pooled odds ratio (OR) and 95% confidence interval (CI) of achieving 20% improvement according to the Ankylosing Spondylitis Assessment Study group response criteria 20 (ASAS20) across trials were calculated...
May 28, 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/28550592/certolizumab-pegol-for-treating-rheumatoid-arthritis-following-inadequate-response-to-a-tnf-%C3%AE-inhibitor-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#8
REVIEW
Iñigo Bermejo, Matt Stevenson, Rachel Archer, John W Stevens, Edward Goka, Mark Clowes, David L Scott, Adam Young
As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer (UCB Pharma) of certolizumab pegol (CZP; Cimzia(®)) to submit evidence of its clinical and cost effectiveness for the treatment of rheumatoid arthritis (RA) following inadequate response to a tumour necrosis factor-α inhibitor (TNFi). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
May 26, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28543445/psoriasis-in-those-planning-a-family-pregnant-or-breast-feeding-the-australasian-psoriasis-collaboration
#9
REVIEW
Marius Rademaker, Karen Agnew, Megan Andrews, Katherine Armour, Chris Baker, Peter Foley, John Frew, Kurt Gebauer, Monisha Gupta, Debra Kennedy, Gillian Marshman, John Sullivan
The Australasian Psoriasis Collaboration has reviewed the evidence for managing moderate to severe psoriasis in those who are pregnant or are breast-feeding, or planning a family. The severity of the psoriasis, associated comorbidities and specific anti-psoriasis treatment, along with other exposures, can have a deleterious effect on pregnancy outcomes. Psoriasis itself increases the risk of preterm and low birthweight babies, along with spontaneous and induced abortions, but no specific birth defects have been otherwise demonstrated...
May 23, 2017: Australasian Journal of Dermatology
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
#10
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
#11
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
#12
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
#13
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
#14
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...
July 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
#15
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
#16
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...
July 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28405087/leukocytoclastic-vasculitis-drug-reaction-to-certolizumab-pegol
#17
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
#18
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
#19
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...
June 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/28353055/accounting-for-pharmacokinetic-variability-of-certolizumab-pegol-in-patients-with-crohn-s-disease
#20
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
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