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23 records – page 1 of 3.

Adalimumab for treatment of moderate to severe chronic plaque psoriasis of the hands and feet: efficacy and safety results from REACH, a randomized, placebo-controlled, double-blind trial.

https://arctichealth.org/en/permalink/ahliterature138480
Source
Arch Dermatol. 2011 Apr;147(4):429-36
Publication Type
Article
Date
Apr-2011
Author
Craig Leonardi
Richard G Langley
Kim Papp
Stephen K Tyring
Norman Wasel
Ronald Vender
Kristina Unnebrink
Shiraz R Gupta
Wendell C Valdecantos
Jerry Bagel
Author Affiliation
Central Dermatology, 1034 S Brentwood Blvd, Ste 600, St Louis, MO 63117, USA. leonardi@centralderm.com
Source
Arch Dermatol. 2011 Apr;147(4):429-36
Date
Apr-2011
Language
English
Publication Type
Article
Keywords
Adult
Anti-Inflammatory Agents - adverse effects - therapeutic use
Antibodies, Monoclonal - adverse effects - therapeutic use
Antibodies, Monoclonal, Humanized
Canada
Double-Blind Method
Foot
Hand
Humans
Male
Middle Aged
Nasopharyngitis - chemically induced
Psoriasis - drug therapy
Severity of Illness Index
Treatment Outcome
United States
Abstract
To determine the efficacy, safety, and sustainability of response to adalimumab therapy for moderate to severe chronic plaque psoriasis involving hands and/or feet.
Sixteen-week, randomized, double-blind, placebo-controlled evaluation of adalimumab therapy for moderate to severe chronic plaque psoriasis involving the hands and/or feet with a 12-week open-label extension (Randomized Controlled Evaluation of Adalimumab in Treatment of Chronic Plaque Psoriasis of the Hands and Feet [REACH]).
Multicenter outpatient study in the United States and Canada.
Patients with chronic plaque psoriasis on the hands and/or feet with a Physician's Global Assessment of hands and/or feet (hfPGA) score of "moderate" or above.
Patients were randomized 2:1 to adalimumab (80 mg at week 0, then 40 mg every other week starting at week 1) or to matching placebo.
Percentage of patients achieving an hfPGA score of "clear" or "almost clear" at week 16.
Seventy-two patients (adalimumab [n = 49];placebo [n = 23]) were evaluated. Baseline percentages of patients with moderate and severe hfPGA scores were 76% and 24%, respectively, for the adalimumab group and 74% and 26%, respectively, for the placebo group. At week 16, 31% and 4% of patients randomized to adalimumab and placebo, respectively, achieved an hfPGA score of clear or almost clear (P = .01). At week 28, 80% of the hfPGA clear or almost clear response was maintained from week 16 (25% for patients randomized to adalimumab). Adverse events in both groups were generally mild to moderate. In both periods combined, nasopharyngitis (27% and 13% for adalimumab- and placebo-treated patients, respectively) was most frequently reported.
Adalimumab is efficacious and well tolerated for treatment of chronic plaque psoriasis of hands and/or feet, with efficacy largely maintained to 28 weeks. Trial Registration clinicaltrials.gov Identifier: NCT00735787.
PubMed ID
21173304 View in PubMed
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[Biological treatments in pediatric IBD].

https://arctichealth.org/en/permalink/ahliterature282927
Source
Lakartidningen. 2017 Feb 21;114
Publication Type
Article
Date
Feb-21-2017
Author
Magnus Svensson
Eva Lindberg
Jonas F Ludvigsson
Source
Lakartidningen. 2017 Feb 21;114
Date
Feb-21-2017
Language
Swedish
Geographic Location
Sweden
Publication Type
Article
Keywords
Antibodies, Monoclonal - adverse effects - therapeutic use
Biological Therapy - adverse effects - statistics & numerical data
Child
Gastroenterologists
Humans
Inflammatory Bowel Diseases - drug therapy - epidemiology
Surveys and Questionnaires
Sweden - epidemiology
Tumor Necrosis Factor-alpha - antagonists & inhibitors
Abstract
Biological treatments in pediatric IBD In Sweden, there are an estimated 1?500 pediatric IBD patients. We sent out a survey regarding the use of biological treatments in pediatric IBD to pediatric gastroenterologists in Sweden. Of 1?098 recorded IBD patients, 17% had ongoing treatment with biological drugs. The drugs used were almost exclusively infliximab and adalimumab, i.e. anti-TNF-alpha. Use of biologics varied among responders. Anaphylactic reactions and other types of infusion reactions were the most frequent side effects.
PubMed ID
28245034 View in PubMed
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A Canadian phase II study evaluating the efficacy of rituximab in the management of patients with relapsed/refractory thrombotic thrombocytopenic purpura.

https://arctichealth.org/en/permalink/ahliterature152882
Source
Kidney Int Suppl. 2009 Feb;(112):S55-8
Publication Type
Article
Date
Feb-2009
Author
Stephen R Foley
Kathryn Webert
Donald M Arnold
Gail A Rock
William F Clark
David Barth
David M Sutton
Author Affiliation
Department of Pathology and Molecular Medicine, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada. foleyr@hhsc.ca
Source
Kidney Int Suppl. 2009 Feb;(112):S55-8
Date
Feb-2009
Language
English
Publication Type
Article
Keywords
ADAM Proteins - immunology
Antibodies, Monoclonal - adverse effects - therapeutic use
Antibodies, Monoclonal, Murine-Derived
Autoantibodies - blood
B-Lymphocytes - drug effects - immunology
Canada
Clinical Trials, Phase II as Topic
Humans
Immunosuppressive Agents - adverse effects - therapeutic use
Patient Selection
Plasma Exchange
Purpura, Thrombotic Thrombocytopenic - blood - drug therapy - immunology
Recurrence
Risk assessment
Treatment Failure
von Willebrand Factor - metabolism
Abstract
Rituximab is a chimeric monoclonal antibody that targets the human CD-20 antigen present on malignant and normal B lymphocytes. Recent clinical studies have shown a significant response rate when this drug is given to selected patients with thrombotic thrombocytopenic purpura (TTP). Given that the clinical manifestations of TTP may be the direct result of an auto-antibody against a regulatory Von Willebrand factor enzyme (ADAMTS13), it makes biological sense to consider a therapy that has the ability to diminish or eradicate antibody-producing B cells. Despite initial positive results, there is a need to identify which patients derive durable benefit from this agent. As in other conditions that utilize therapeutic immunosuppression, there is a risk that the addition of rituximab may also lead to serious opportunistic infections.
PubMed ID
19180138 View in PubMed
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Chimeric monoclonal antibody to tumor necrosis factor alpha (infliximab) in psoriasis.

https://arctichealth.org/en/permalink/ahliterature169241
Source
Indian J Dermatol Venereol Leprol. 2006 Mar-Apr;72(2):133-5
Publication Type
Article
Author
J. Sridhar
Plk Desylva
Y D Singh
Author Affiliation
INHS Kalyani, Visakhapatnam, Andhra Pradesh, India. sridharjandhya@yahoo.com.
Source
Indian J Dermatol Venereol Leprol. 2006 Mar-Apr;72(2):133-5
Language
English
Publication Type
Article
Keywords
Antibodies, Monoclonal - adverse effects - therapeutic use
Humans
Middle Aged
Pilot Projects
Psoriasis - drug therapy - pathology
Tumor Necrosis Factor-alpha - antagonists & inhibitors
Abstract
Insights into the pathogenesis of psoriasis have provided opportunities to target key steps in the disease process. Tumor necrosis factor-alpha (TNF- alpha) being crucial to the pathogenesis of psoriasis, monoclonal antibodies against this cytokine have proved useful in its treatment.
To study the efficacy of chimeric monoclonal antibody to TNF- alpha (infliximab) in Indian patients with recalcitrant psoriasis vulgaris.
Three patients with recalcitrant psoriasis vulgaris were studied. Baseline haemogram, biochemical parameters, chest radiograph and Mantoux skin test were performed. A loading dose regimen of 5 mg/kg infliximab was administered at weeks 0, 2 and 6. PASI assessment, adverse drug event monitoring and laboratory assessments were carried out at 2-week intervals until week 10. Patients were followed up until week 22 for relapse.
Infliximab was well tolerated. The mean PASI was 25.4 at presentation and declined to 5.5 at 10 weeks. PASI 75 was attained at a mean of 9.6 weeks. Relapse occurred at a mean of 18.6 weeks after the first infusion.
This study on Indian patients brings out the importance of cytokine-based therapies in psoriasis. Indigenous production could make these therapies a viable therapeutic option for psoriasis patients in the near future.
PubMed ID
16707820 View in PubMed
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Does cancer that occurs during or after anti-tumor necrosis factor therapy have a worse prognosis? A national assessment of overall and site-specific cancer survival in rheumatoid arthritis patients treated with biologic agents.

https://arctichealth.org/en/permalink/ahliterature137213
Source
Arthritis Rheum. 2011 Jul;63(7):1812-22
Publication Type
Article
Date
Jul-2011
Author
Pauline Raaschou
Julia F Simard
Martin Neovius
Johan Askling
Author Affiliation
Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.
Source
Arthritis Rheum. 2011 Jul;63(7):1812-22
Date
Jul-2011
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal - adverse effects - therapeutic use
Antirheumatic Agents - adverse effects - therapeutic use
Arthritis, Rheumatoid - drug therapy - epidemiology
Female
Humans
Incidence
Male
Middle Aged
Neoplasms - epidemiology - etiology
Prognosis
Registries
Risk factors
Sweden - epidemiology
Tumor Necrosis Factor-alpha - antagonists & inhibitors
Abstract
Tumor necrosis factor (TNF) may affect tumor development and spreading. While data on the incidence of cancer following anti-TNF therapy have been published, the purpose of this study was to examine the clinical presentation and outcome of cancers that develop during or after anti-TNF therapy.
By linking data from Swedish clinical registries of rheumatoid arthritis (RA) patients, including Anti-Rheumatic Therapy in Sweden (ARTIS), the Swedish Biologics Register, with nationwide data on hospitalizations and outpatient visits for RA, we assembled a cohort of 78,483 RA patients who were alive in 1999 or who entered the cohort thereafter. Of these, 8,562 patients started therapy with a biologic agent (98% started an anti-TNF) during the period from January 1, 1999 to December 31, 2007. Linkage to the Swedish Cancer Register and other registers identified first primary cancers occurring during 1999-2007 as well as post-cancer survival through March 31, 2009. Through this linkage, we identified 314 cancers in patients who were undergoing, or had a history of, treatment with biologic agents and 4,650 cancers in patients who were biologics-naive at the time of cancer diagnosis. The distributions of tumor stage among the biologics-exposed and the biologics-naive patients were compared. The relative risk of death among the biologics-exposed versus the 586 matched biologics-naive cancer cases were assessed by Cox regression analyses. Through chart review in a defined subset, we gathered additional clinical information and validated the diagnoses.
For all cancers combined, the distribution of cancer stages at the time of cancer diagnosis was largely similar between those in the biologics-exposed and the matched biologics-naive groups. Based on the total of 113 deaths among those with cancer in the biologics-exposed group versus the 256 deaths among those with cancer in the biologics-naive group, the relative risk of death following cancer associated with exposure to anti-TNF was 1.1 (95% confidence interval 0.8-1.6).
During routine care, cancers that occur following anti-TNF therapy are not characterized by any markedly altered stage at presentation or by altered post-cancer survival rates.
Notes
Comment In: Arthritis Rheum. 2011 Jul;63(7):1773-521305509
PubMed ID
21305513 View in PubMed
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Efalizumab discontinuation: a practical strategy.

https://arctichealth.org/en/permalink/ahliterature150841
Source
J Dermatolog Treat. 2009;20(3):132-6
Publication Type
Article
Date
2009
Author
Rupa Pugashetti
John Koo
Author Affiliation
Department of Dermatology, University of California, San Francisco, CA 94118, USA.
Source
J Dermatolog Treat. 2009;20(3):132-6
Date
2009
Language
English
Publication Type
Article
Keywords
Adverse Drug Reaction Reporting Systems
Antibodies, Monoclonal - adverse effects - therapeutic use
Canada
Drug and Narcotic Control
Drug-Related Side Effects and Adverse Reactions
Europe
Female
Humans
Leukoencephalopathy, Progressive Multifocal - chemically induced - diagnosis - epidemiology
Male
Psoriasis - drug therapy
Risk assessment
United States
Withholding Treatment
Abstract
Efalizumab is a recombinant, humanized IgG1 monoclonal antibody used in the treatment of plaque psoriasis. Efalizumab specifically targets T cells, leading to the subsequent inhibition of T-cell activation. The recent cases (three confirmed and one unconfirmed but suspected case) of the demyelinating disease progressive multifocal leukoencephalopathy (PML) have resulted in efalizumab being pulled from the market by European and Canadian regulatory agencies. Furthermore, manufacturer Genentech, Inc. has voluntarily withdrawn efalizumab from the United States market as of April 2009. In light of these events, this report is a practical guide to transitioning patients from efalizumab to alternative psoriasis therapies. The major consideration is the possibility for efalizumab-associated rebound of psoriasis. According to limited available literature and in the experience of the authors, the most effective agent for minimizing or preventing rebound is cyclosporine at the maximum dermatologic dose of 5 mg/kg per day.
PubMed ID
19459081 View in PubMed
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Effectiveness and safety of infliximab in rheumatoid arthritis: analysis from a Canadian multicenter prospective observational registry.

https://arctichealth.org/en/permalink/ahliterature256508
Source
Arthritis Care Res (Hoboken). 2014 Aug;66(8):1142-51
Publication Type
Article
Date
Aug-2014
Author
Carter Thorne
William G Bensen
Denis Choquette
Andrew Chow
Majed Khraishi
Christopher J Atkins
John T Kelsall
Allen J Lehman
May Shawi
Hayssam Khalil
Francois Nantel
Emmanouil Rampakakis
John S Sampalis
Susan Otawa
Author Affiliation
Southlake Regional Health Centre, Newmarket, and University of Toronto, Toronto, Ontario, Canada.
Source
Arthritis Care Res (Hoboken). 2014 Aug;66(8):1142-51
Date
Aug-2014
Language
English
Publication Type
Article
Keywords
Adult
Aged
Antibodies, Monoclonal - adverse effects - therapeutic use
Antirheumatic Agents - adverse effects - therapeutic use
Arthritis, Rheumatoid - drug therapy
Canada
Female
Humans
Male
Middle Aged
Prospective Studies
Registries
Treatment Outcome
Abstract
To describe the profile of rheumatoid arthritis (RA) patients treated with infliximab in Canadian routine care and to assess the real-world effectiveness and safety of infliximab.
Biologics-naive RA patients from the Biologic Treatment Registry Across Canada were stratified based on their enrollment year. Effectiveness was assessed with the changes in clinical/laboratory parameters and patient-reported outcomes and the achievement of minimal disease activity and remission. Safety was assessed with the incidence of treatment-emergent adverse events (AEs).
Among 628 patients, 45.9%, 34.6%, and 19.6% were enrolled between 2002-2005, 2005-2008, and 2008-2011, respectively. Patients recruited in more recent years had significantly lower Disease Activity Score with a 28-joint count using the C-reactive protein level (DAS28-CRP), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), swollen joint count in 28 joints, tender joint count in 28 joints, physician's global assessment of disease activity, patient's global assessment of disease activity, Health Assessment Questionnaire disability index, pain, erythrocyte sedimentation rate, and CRP level (P
PubMed ID
24470077 View in PubMed
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Efficacy and safety of adalimumab in Canadian patients with moderate to severe Crohn's disease: results of the Adalimumab in Canadian SubjeCts with ModErate to Severe Crohn's DiseaSe (ACCESS) trial.

https://arctichealth.org/en/permalink/ahliterature131362
Source
Can J Gastroenterol. 2011 Aug;25(8):419-25
Publication Type
Article
Date
Aug-2011
Author
Remo Panaccione
Edward V Loftus
David Binion
Kevin McHugh
Shamsul Alam
Naijun Chen
Benoît Guerette
Parvez Mulani
Jingdong Chao
Author Affiliation
University of Calgary, Calgary, Alberta, USA. rpanacci@ucalgary.ca
Source
Can J Gastroenterol. 2011 Aug;25(8):419-25
Date
Aug-2011
Language
English
Publication Type
Article
Keywords
Adult
Anti-Inflammatory Agents - adverse effects - therapeutic use
Antibodies, Monoclonal - adverse effects - therapeutic use
Antibodies, Monoclonal, Humanized
Canada
Crohn Disease - drug therapy - physiopathology
Efficiency
Female
Follow-Up Studies
Humans
Injections, Subcutaneous
Male
Middle Aged
Quality of Life
Remission Induction - methods
Severity of Illness Index
Treatment Outcome
Tumor Necrosis Factor-alpha - antagonists & inhibitors
Abstract
To evaluate open-label adalimumab therapy for clinical effectiveness, fistula healing, patient-reported outcomes and safety in Canadian patients with moderate to severe Crohn's disease (CD) who were either naive to or previously exposed to antitumour necrosis factor (anti-TNF) therapy.
Patients with moderate to severe CD (CD activity index [CDAI] score of greater than 220, or Harvey-Bradshaw index [HBI] of 7 or greater) were eligible. Patients received open-label adalimumab as induction (160 mg and 80 mg subcutaneously [sc]) at weeks 0 and 2, respectively and maintenance (40 mg sc every other week) therapy. At or after eight weeks, patients with flare or nonresponse could have their dosage increased to 40 mg sc weekly. Patients were followed for a minimum of six months or until adalimumab was commercially available in Canada.
Of the 304 patients enrolled, 160 were infliximab experienced, while 144 were anti-TNF naive. HBI remission (HBI score of 4 or lower) at week 24 was achieved by 53% of anti-TNF-naive and 36% of infliximab-experienced patients (P
Notes
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PubMed ID
21912766 View in PubMed
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Etanercept, infliximab, and leflunomide in established rheumatoid arthritis: clinical experience using a structured follow up programme in southern Sweden.

https://arctichealth.org/en/permalink/ahliterature13947
Source
Ann Rheum Dis. 2002 Sep;61(9):793-8
Publication Type
Article
Date
Sep-2002
Author
P. Geborek
M. Crnkic
I F Petersson
T. Saxne
Author Affiliation
Department of Rheumatology, Lund University Hospital, S-221 85 Lund, Sweden. pierre.geborek@reum.lu.se
Source
Ann Rheum Dis. 2002 Sep;61(9):793-8
Date
Sep-2002
Language
English
Publication Type
Article
Keywords
Anti-Inflammatory Agents, Non-Steroidal - adverse effects - therapeutic use
Antibodies, Monoclonal - adverse effects - therapeutic use
Antirheumatic Agents - adverse effects - therapeutic use
Arthritis, Rheumatoid - drug therapy - pathology
Chi-Square Distribution
Clinical Protocols
Comparative Study
Feasibility Studies
Female
Humans
Immunoglobulin G - adverse effects - therapeutic use
Isoxazoles - adverse effects - therapeutic use
Male
Middle Aged
Monitoring, Physiologic
Product Surveillance, Postmarketing
Prospective Studies
Pyrimidines - antagonists & inhibitors
Receptors, Tumor Necrosis Factor - therapeutic use
Sweden
Treatment Outcome
Tumor Necrosis Factor-alpha - antagonists & inhibitors - immunology
Abstract
OBJECTIVE: To explore the feasibility of prospectively monitoring treatment efficacy and tolerability of infliximab, etanercept, and leflunomide over a two year period in patients with established rheumatoid arthritis (RA) in clinical practice using a structured protocol. METHODS: All patients with RA at seven centres in southern Sweden, for whom at least two disease modifying antirheumatic drugs, including methotrexate, had failed or not been tolerated, who started treatment with either infliximab, etanercept, or leflunomide were included. They were evaluated at predefined times using a standardised protocol including items required for evaluating response to the American College of Rheumatology (ACR) or EULAR criteria. All adverse events were recorded using World Health Organisation terminology. Concomitant treatment and survival while receiving a drug were recorded. RESULTS: During the study 166 patients were treated with etanercept, 135 with infliximab, and 103 with leflunomide. Treatment response as determined by the ACR and EULAR response criteria was similar for the tumour necrosis factor (TNF) blockers. The TNF blockers performed significantly better than leflunomide both as determined by the response criteria and by survival on drug analysis. Thus 79% and 75% continued to receive etanercept or infliximab compared with 22% of patients who started leflunomide after 20 months. The spectrum of side effects did not differ from those previously reported in the clinical trials. The initial two year experience of a protocol for postmarketing surveillance of etanercept, infliximab, and leflunomide shows that a structured protocol with central data handling can be used in clinical practice for documenting the performance of newly introduced drugs. CONCLUSIONS: Efficacy data for the TNF blockers comply with results in clinical trials, whereas leflunomide appeared to perform worse than in clinical trials. Prolonged monitoring is required to identify possible rare side effects.
PubMed ID
12176803 View in PubMed
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23 records – page 1 of 3.