Safety of efalizumab therapy in patients with moderate to severe psoriasis: an open-label extension of a phase IIIb trial.

Abstract:

BACKGROUND:Psoriasis is a chronic autoimmune disease characterized by infiltration of the dermis and epidermis by activated T cells and the hyperproliferation and abnormal differentiation of keratinocytes. It is a life-long disease with alternating periods of remission and recurrence. Efalizumab is a humanized, recombinant, T-cell targeting monoclonal antibody, approved for use in adults with chronic moderate to severe plaque psoriasis. OBJECTIVE:To assess the safety of continued or newly initiated treatment with efalizumab for up to 48 weeks in patients with psoriasis who were treated previously with efalizumab or placebo. METHODS:This study was an open-label, 48-week extension of a previously published 12-week, randomized, double-blind, parallel-group, placebo-controlled, multicentre, phase IIIb study, carried out in the US and Canada between 24 October 2002 and 2 July 2004. Patients were followed and treated at the study clinic in an outpatient setting and also were trained to self-administer the drug at home. Patients comprising individuals with chronic moderate to severe plaque psoriasis who had completed the 12-week, placebo-controlled segment of the study were eligible for enrolment in the extension phase. Of the 686 patients enrolled in the study, 636 (92.7%) enrolled in the open-label extension of the study, 418 of whom had received 12 weeks of efalizumab therapy and 218 of whom had received 12 weeks of placebo. All patients entering the open-label phase of the study received efalizumab 1 mg/kg/wk for an additional 48 weeks, for a maximum exposure of up to 60 weeks. Safety was evaluated by an assessment of adverse events, including infections and serious adverse events. RESULTS:The rate of withdrawal due to adverse events remained low throughout the trial, ranging from 1.2% to 6.6% during the 12-week segments of the open-label extension phase of the trial. The incidence of adverse events decreased with increased exposure to efalizumab; the incidence during the initial 12 weeks of exposure to efalizumab was 79.0% compared with 72.9% for patients exposed to placebo. Patients treated with efalizumab for 13-24 weeks, 25-36 weeks, 37-48 weeks and 49-60 weeks experienced adverse events at an incidence of 66.8%, 54.3%, 49.6% and 48.5%, respectively. The incidence of serious adverse events ranged from 1.6% to 3.5% during the 12-week segments of efalizumab therapy, compared with an incidence of 3.4% for placebo-treated patients. The incidence of infection ranged from 9.9% to 14.7% during the 12-week segments of efalizumab therapy, compared with an incidence of 19.1% for placebo-treated patients. Malignancies were reported with an incidence of

journal_name

Drug Saf

journal_title

Drug safety

authors

Hamilton T,Menter A,Caro I,Compton P,Sobell J,Papp KA

doi

10.2165/00002018-200831080-00008

subject

Has Abstract

pub_date

2008-01-01 00:00:00

pages

715-26

issue

8

eissn

0114-5916

issn

1179-1942

pii

3188

journal_volume

31

pub_type

杂志文章,随机对照试验
  • Early steps in the development of a claims-based targeted healthcare safety monitoring system and application to three empirical examples.

    abstract:BACKGROUND:Several efforts are under way to develop and test methods for prospective drug safety monitoring using large, electronic claims databases. Prospective monitoring systems must incorporate signalling algorithms and techniques to mitigate confounding in order to minimize false positive and false negative signal...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/11594770-000000000-00000

    authors: Wahl PM,Gagne JJ,Wasser TE,Eisenberg DF,Rodgers JK,Daniel GW,Wilson M,Schneeweiss S,Rassen JA,Patrick AR,Avorn J,Bohn RL

    更新日期:2012-05-01 00:00:00

  • Drug-induced skin, nail and hair disorders.

    abstract::Drug eruptions are among the most common adverse drug reactions, affecting approximately 3% of hospitalised patients. Although the rate of severe cutaneous adverse reactions to medications is low, these reactions can affect anyone who takes medication, and can result in death or disability. Two general patterns can be...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200730110-00003

    authors: Valeyrie-Allanore L,Sassolas B,Roujeau JC

    更新日期:2007-01-01 00:00:00

  • Effect of competition bias in safety signal generation: analysis of a research database of spontaneous reports in France.

    abstract:BACKGROUND:Automated disproportionality analysis of spontaneous reporting is increasingly used routinely. It can theoretically be influenced by a competition bias for signal detection owing to the presence of reports related to well-established drug-event associations. OBJECTIVE:The aim of the study was to explore the...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/BF03261981

    authors: Pariente A,Avillach P,Salvo F,Thiessard F,Miremont-Salamé G,Fourrier-Reglat A,Haramburu F,Bégaud B,Moore N,Association Française des Centres Régionaux de Pharmacovigilance (CRPV).

    更新日期:2012-10-01 00:00:00

  • Coronary Events After Dispensing of Ibuprofen: A Propensity Score-Matched Cohort Study Versus Paracetamol in the French Nationwide Claims Database Sample.

    abstract:INTRODUCTION:Non-steroidal anti-inflammatory drugs are associated with a dose and duration-dependent coronary risk. There is little information concerning analgesic-dose ibuprofen, among the most widely used drugs worldwide. OBJECTIVE:Our objective was to measure the risks of acute coronary syndrome (ACS) after dispen...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-018-0686-7

    authors: Duong M,Abouelfath A,Lassalle R,Droz C,Blin P,Moore N

    更新日期:2018-11-01 00:00:00

  • Safety of Human Papillomavirus Vaccines: An Updated Review.

    abstract::Human papillomavirus (HPV) vaccines are now included in immunisation programmes in 71 countries. Unfortunately, uptake has been impacted in some countries by reduced confidence in the safety of the HPV vaccine. In 2013, we published an extensive review demonstrating a reassuring safety profile for bivalent (2vHPV) and...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.1007/s40264-017-0625-z

    authors: Phillips A,Patel C,Pillsbury A,Brotherton J,Macartney K

    更新日期:2018-04-01 00:00:00

  • Feasibility and Educational Value of a Student-Run Pharmacovigilance Programme: A Prospective Cohort Study.

    abstract:INTRODUCTION:Pharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme....

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-016-0502-1

    authors: Schutte T,Tichelaar J,Reumerman MO,van Eekeren R,Rolfes L,van Puijenbroek EP,Richir MC,van Agtmael MA

    更新日期:2017-05-01 00:00:00

  • Adverse effects of coumarin anticoagulants.

    abstract::The biochemistry of vitamin K metabolism and the role of vitamin K-dependent gamma-carboxylation of the vitamin K-dependent coagulation factors are now well understood. Likewise, there is a clear understanding of the role of oral anticoagulants in the inhibition of these coagulation factors. However, the effect of ora...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199309040-00004

    authors: Pineo GF,Hull RD

    更新日期:1993-10-01 00:00:00

  • Incidence of infusion-associated reactions with rituximab for treating multiple sclerosis: a retrospective analysis of patients treated at a US centre.

    abstract:BACKGROUND:Rituximab is a monoclonal antibody approved for treating CD20-positive B-cell non-Hodgkin's lymphoma and rheumatoid arthritis but is used off-label for treating many autoimmune disorders, including multiple sclerosis (MS). Similarly to other monoclonal antibodies, the incidence of infusion-related reactions ...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/11585960-000000000-00000

    authors: Brown BA,Torabi M

    更新日期:2011-02-01 00:00:00

  • Pharmacovigilance of Regenerative Medicine Under the Amended Pharmaceutical Affairs Act in Japan.

    abstract::Two Japanese regulatory agencies, the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency announced the implementation of a new review system called 'Conditional Approval,' specifically for the emerging field of regenerative medicine, in an amendment to the Pharmaceutical Affairs ...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.1007/s40264-017-0517-2

    authors: Inokuma Y

    更新日期:2017-06-01 00:00:00

  • Safety of zafirlukast: results of a postmarketing surveillance study on 7976 patients in England.

    abstract:OBJECTIVES:A prescription event monitoring (PEM) postmarketing surveillance study was carried out to examine the safety of zafirlukast as used in general practice in England. METHODS:Exposure data were obtained from the first National Health Service (NHS) prescription dispensed for patients whose prescription details ...

    journal_title:Drug safety

    pub_type: 临床试验,杂志文章

    doi:10.2165/00002018-200730050-00005

    authors: Twaites BR,Wilton LV,Shakir SA

    更新日期:2007-01-01 00:00:00

  • Clinical implications of pharmacogenetic variation on the effects of statins.

    abstract::The last decade has seen an increase in the trend of HMG-CoA reductase inhibitor (statin) usage in the Western world, which does not come as a surprise noting that the latest American Heart Association heart and stroke statistics indicate an alarming prevalence of 80  million Americans (one in three) with one or more ...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/11584380-000000000-00000

    authors: Maggo SD,Kennedy MA,Clark DW

    更新日期:2011-01-01 00:00:00

  • Measles vaccination and inflammatory bowel disease: controversy laid to rest?

    abstract::The increasing incidence of Crohn's disease has lead to speculation about changes in exposures to environmental or infectious agents. Considerable attention has focused on the role of measles infection and/or vaccination in the pathogenesis of Crohn's disease and ulcerative colitis. Current evidence regarding the asso...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200124130-00001

    authors: Davis RL,Bohlke K

    更新日期:2001-01-01 00:00:00

  • Allergic reactions to medicines derived from Pelargonium species.

    abstract::Pelargonium (Pelargonium sidoides DC and P. reniforme Curtis) is reported to have immune modulating properties and antibacterial activity, and Pelargonium extracts have been used for the treatment of respiratory tract and gastrointestinal infections. Introduced in the early 1980s in Germany, Umckaloabo (ISO Arzneimitt...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200730080-00004

    authors: de Boer HJ,Hagemann U,Bate J,Meyboom RH

    更新日期:2007-01-01 00:00:00

  • Lipodystrophy syndrome in patients with HIV infection: quality of life issues.

    abstract::Current antiretroviral therapy has lead to longer survival in patients infected with HIV, but it is also associated with new and important problems. Body fat redistribution and metabolic abnormalities, the so-called lipodystrophy syndrome, are among the most prevalent and worrisome ones. While an increasing number of ...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200124030-00001

    authors: Martínez E,Garcia-Viejo MA,Blanch L,Gatell JM

    更新日期:2001-01-01 00:00:00

  • Monitoring outcomes of pregnancy following drug exposure: a company-based pregnancy registry program.

    abstract::Women who discover they are pregnant after exposure to a drug and pregnant women who have a condition that requires continued treatment during pregnancy are told to balance the benefits and risks of the exposure to justify continuation of treatment, discontinuation of treatment or, possibly, pregnancy termination. How...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200427060-00001

    authors: Shields KE,Wiholm BE,Hostelley LS,Striano LF,Arena SR,Sharrar RG

    更新日期:2004-01-01 00:00:00

  • Risks and benefits of drugs used in the management of the hyperactive child.

    abstract::Childhood hyperactivity is a common behavioural complaint. The therapeutic options for physicians caring for children with hyperactivity are considerable and varied; current recommendations call for a multidisciplinary approach, including when necessary the use of drug therapy. Central nervous system stimulants are th...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199309010-00004

    authors: Fox AM,Rieder MJ

    更新日期:1993-07-01 00:00:00

  • Improving follow-up rates in spontaneous adverse drug reaction reporting: effectiveness of a targeted letter used by a regional centre in the UK.

    abstract:BACKGROUND:Spontaneous reports of suspected adverse drug reactions to regulatory bodies and market authorization holders are important in pharmacovigilance. Follow-up information, which can be difficult to obtain, is often required from reporters; therefore, we developed targeted follow-up letters that we hoped would m...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/11318940-000000000-00000

    authors: Anton C,Cox AR,Ferner RE

    更新日期:2009-01-01 00:00:00

  • Clinical features and management of severe dermatological reactions to drugs.

    abstract::Cutaneous adverse drug reactions are a frequent occurrence and have been reported in more than 2% of hospitalised patients. Among the most commonly involved drugs are sulphonamides, penicillins, anticonvulsants and non-steroidal anti-inflammatory drugs. Two groups of mechanisms are involved in the pathogenesis of drug...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199005010-00005

    authors: Raviglione MC,Pablos-Mendez A,Battan R

    更新日期:1990-01-01 00:00:00

  • Paraquat poisoning. An overview of the current status.

    abstract::Paraquat is a bipyridyl compound with no known chronic toxicity or teratogenicity. It is poorly absorbed when inhaled, but causes severe illness when ingested orally, death usually occurring within 2 days of ingestion of 50 mg/kg. At lower doses death may be delayed for several weeks. The toxic compound accumulates in...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199005040-00002

    authors: Bismuth C,Garnier R,Baud FJ,Muszynski J,Keyes C

    更新日期:1990-07-01 00:00:00

  • The use of analgesics in patients with asthma.

    abstract::Aspirin (acetylsalicylic acid) and other nonsteroidal anti-inflammatory drugs (NSAIDs) cause deterioration in respiratory function in approximately 10% of adults with asthma and a smaller proportion of children with asthma. We propose evidence-based guidelines for the safe use of NSAIDs in individuals with asthma foll...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-200124110-00004

    authors: Levy S,Volans G

    更新日期:2001-01-01 00:00:00

  • Benefits and risks of transfer from oral agents to insulin in type 2 diabetes mellitus.

    abstract::The treatment of type 2 diabetes mellitus remains controversial. Since most patients are overweight or obese, regimens based on dietary modification and increased physical exercise are logical and safe treatment approaches. However, the long term impact of these interventions is frequently disappointing and pharmacoth...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199921010-00002

    authors: Evans A,Krentz AJ

    更新日期:1999-07-01 00:00:00

  • Validation of statistical signal detection procedures in eudravigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling.

    abstract:BACKGROUND:Screening large databases of spontaneous case reports of possible adverse drug reactions (ADRs) is an established method of identifying hitherto unknown adverse effects of medicinal products; however, there is a lack of consensus concerning the value of formal statistical screening procedures in guiding such...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/11534410-000000000-00000

    authors: Alvarez Y,Hidalgo A,Maignen F,Slattery J

    更新日期:2010-06-01 00:00:00

  • Tyrosine kinase inhibitors: their on-target toxicities as potential indicators of efficacy.

    abstract::Tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of certain forms of cancers, raising hopes for many patients with otherwise unresponsive tumours. While these agents are generally well tolerated, clinical experience with them has highlighted their unexpected association with serious toxic effects on...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.1007/s40264-013-0050-x

    authors: Shah DR,Shah RR,Morganroth J

    更新日期:2013-06-01 00:00:00

  • Cardiovascular Profile of Valbenazine: Analysis of Pooled Data from Three Randomized, Double-Blind, Placebo-Controlled Trials.

    abstract:INTRODUCTION:Valbenazine is a novel vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. OBJECTIVE:Using data from double-blind, placebo-controlled trials, analyses were conducted to evaluate the cardiovascular effects of once-daily valbenazine in patients with a psyc...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-017-0623-1

    authors: Thai-Cuarto D,O'Brien CF,Jimenez R,Liang GS,Burke J

    更新日期:2018-04-01 00:00:00

  • Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study.

    abstract:INTRODUCTION:Real-world data on the comparative effectiveness and safety of switching among different epoetins (including originators and biosimilars) are limited. In light of current debate about interchangeability, prescribers, some patient groups and decision makers are calling for additional post-marketing evidence...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-019-00845-y

    authors: Belleudi V,Trotta F,Addis A,Ingrasciotta Y,Ientile V,Tari M,Gini R,Pastorello M,Scondotto S,Cananzi P,Traversa G,Davoli M,Trifirò G,Italian Biosimilar Network (ItaBioNet).

    更新日期:2019-12-01 00:00:00

  • All-Cause Mortality Associated with Tramadol Use: A Case-Crossover Study.

    abstract:INTRODUCTION:Although the mortality risk associated with tramadol use in children has triggered the revision of tramadol drug labeling, the mortality risk in adults has not been thoroughly explored. OBJECTIVE:The objective of this study was to evaluate whether tramadol use is associated with mortality in various risk ...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.1007/s40264-018-00786-y

    authors: Jeong S,Tchoe HJ,Li J,Shin JY

    更新日期:2019-06-01 00:00:00

  • Effects of estazolam and flurazepam on cardiopulmonary function in patients with chronic obstructive pulmonary disease.

    abstract::Benzodiazepine drugs have been shown to suppress respiratory function in patients with chronic obstructive pulmonary disease (COPD). We designed a placebo-controlled crossover study to compare the effects of a new benzodiazepine, estazolam ('ProSom'), with those of flurazepam ('Dalmane') on cardiopulmonary function in...

    journal_title:Drug safety

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.2165/00002018-199207020-00006

    authors: Cohn MA,Morris DD,Juan D

    更新日期:1992-03-01 00:00:00

  • Safety aspects of parenteral iron in patients with end-stage renal disease.

    abstract::Absolute and functional iron deficiency is the most common cause of epoetin (recombinant human erythropoietin) hyporesponsiveness in renal failure patients. Diagnostic procedures for determining iron deficiency include measurement of serum iron levels, serum ferritin levels, saturation of transferrin and percentage of...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.2165/00002018-199717040-00004

    authors: Sunder-Plassmann G,Hörl WH

    更新日期:1997-10-01 00:00:00

  • Quantitative Risk-Benefit Analysis of Probiotic Use for Irritable Bowel Syndrome and Inflammatory Bowel Disease.

    abstract::Probiotics have seen widespread use for a variety of gastrointestinal problems, especially in two common disorders: irritable bowel syndrome and inflammatory bowel disease. Since a wide variety of probiotic preparations has been used, and despite a large number of studies performed, a great deal of heterogeneity exist...

    journal_title:Drug safety

    pub_type: 杂志文章,评审

    doi:10.1007/s40264-015-0349-x

    authors: Bennett WE Jr

    更新日期:2016-04-01 00:00:00

  • Liver damage associated with minocycline use in acne: a systematic review of the published literature and pharmacovigilance data.

    abstract:OBJECTIVE:Minocycline is an antibacterial drug used in the treatment of acne. Concern has been expressed over the possibility of severe adverse reactions to minocycline, including hepatitis. This study set out to identify and characterise reported cases of hepatotoxicity associated with the use of minocycline. METHODS...

    journal_title:Drug safety

    pub_type: 杂志文章

    doi:10.2165/00002018-200023040-00006

    authors: Lawrenson RA,Seaman HE,Sundström A,Williams TJ,Farmer RD

    更新日期:2000-10-01 00:00:00