Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial

Menter, Alan; Tyring, Stephen K.; Gordon, Kenneth B.; Kimball, Alexa B.; Leonardi, Craig L.; Langley, Richard; Strober, Bruce; Kaul, Martin; Gu, Yihua; Okun, Martin; Papp, Kim

doi:10.1016/j.jaad.2007.09.010

Cited by 798 publications

(804 citation statements)

References 14 publications

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“…In all, 38 RCTs (identified in 38 reports)20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57 met the eligibility criteria and were included, as shown in Figure 1. These trials involved a total of 18 024 patients with plaque psoriasis.…”

Section: Resultsmentioning

confidence: 99%

“…Eighteen RCTs compared TNFi (four adalimumab,20, 21, 22, 23, 24 nine etanercept,26, 27, 28, 29, 30, 31, 32, 34, 35 five infliximab36, 37, 38, 39, 40) with placebo, with three studies reporting MACEs; four RCTs compared ustekinumab (anti‐IL‐12/23) with placebo46, 47, 48 with no MACEs reported. One RCT compared ixekizumab with placebo without MACEs reported 56, 57.…”

Section: Resultsmentioning

confidence: 99%

“…Patients in 27 RCTs20, 21, 22, 25, 27, 28, 29, 30, 31, 34, 35, 36, 37, 38, 39, 40, 43, 45, 46, 47, 48, 50, 52, 53, 57 did not experience MACEs while exposed to any interventions but 10 MACEs were observed during the randomized controlled phase of nine studies 23, 26, 32, 33, 42, 44, 49, 51. Overall, the pooled analysis of these nine trials found that there was no statistically significant difference in the risk of MACEs when comparing biologic therapies with placebo (pooled OR 1·45, 95% CI 0·34–6·24, P = 0·62), as shown in Figure 2a.…”

Section: Resultsmentioning

confidence: 99%

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Impact of biologic therapies on risk of major adverse cardiovascular events in patients with psoriasis: systematic review and meta-analysis of randomized controlled trials

et al. 2017

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SummaryConcerns have been raised regarding an increased risk of major adverse cardiovascular events (MACEs) (myocardial infarction, cerebrovascular accident or cardiovascular death) in patients treated with anti‐interleukin (IL)‐12/23 agents for moderate‐to‐severe psoriasis. We aimed to examine the risk of MACEs in adult patients with plaque psoriasis that are exposed to biologic therapies via a meta‐analysis of randomized controlled trials (RCTs). Data were obtained from systematic searches in the Cochrane Library, MEDLINE and Embase, U.S. Food and Drug Administration, European Medicines Agency, individual pharmaceutical companies online search platforms and five trials registers (up to 31 March 2016). We selected RCTs reporting adverse events in adults with plaque psoriasis receiving at least one licensed dose of biologic therapy, conventional systematic therapy or placebo. We calculated Peto odds ratios (ORs) with 95% confidence intervals (CIs) and calculated I 2 statistics to assess heterogeneity. Overall, 38 RCTs involving 18 024 patients were included. No MACEs were observed in 29 studies, while nine RCTs reported 10 patients experiencing MACEs. There was no statistically significant difference in risk of MACEs associated with the use of biologic therapies overall (OR 1·45, 95% CI 0·34–6·24); tumour necrosis factor‐α inhibitors (adalimumab, etanercept and infliximab) (OR 0·67, 95% CI 0·10–4·63); anti‐IL‐17A agents (secukinumab and ixekizumab) (OR 1·00, 95% CI 0·09–11·09) or ustekinumab (OR 4·48, 95% CI 0·24–84·77). No heterogeneity was observed in these comparisons. In conclusion, the limited existing evidence suggests that licensed biologic therapies are not associated with MACEs during the short randomized controlled periods in clinical trials.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Impact of biologic therapies on risk of major adverse cardiovascular events in patients with psoriasis: systematic review and meta-analysis of randomized controlled trials

et al. 2017

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“…Efficacy Adalimumab: Several studies were performed with adalimumab [19][20][21]. One study [43] was not included in the analysis because of a low number of patients per treatment arm (n=23).…”

Section: Review Double-blind Studies and Methodologymentioning

confidence: 99%

Biologicals in the Treatment of Plaque Psoriasis: Drug Selection by Means of the SOJA Method

Janknegt¹

2016

J Pharma Care Health Sys

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The treatment of plaque psoriasis is changing because of the introduction of new treatment options. The goal of this article is to allow a transparent and rational choice of medicines by means of the System of Objectified Judgement Analysis. The following selection criteria (relative weight) were applied: approved indications (40), drug interactions (60), clinical efficacy (400), safety (300), dosage frequency (100) and documentation (100). Acquisition cost was not taken into consideration to allow a preselection on quality aspects only. Adalimumab, etanercept, infliximab and ustekinumab were compared on these criteria. Infliximab and ustekinumab showed the highest scores and are the most suitable medicines for the treatment of severe plaque psoriasis. Of course, cost will play a key role in the final selection in individual hospitals. Weight Approved indications 40 Drug Interactions 60Clinical efficacy 400Safety 300Dosage frequency 100 Documentation 100Total 1000 Selection Criteria Approved IndicationsThe number of licensed indications is a good measure of the applicability and documentation of the drugs. Although this analysis is limited to the treatment of plaque psoriasis, the fact that a drug is approved for (almost) all indications listed below is, from a formulary point of view, advantageous to another drug, which is approved for only one or two applications.The percentage of the maximum score for approved indications was obtained as follows (Table 2): IndicationMaximum Score (%)Plaque psoriasis 50% Psoriatric arthritis 20%Rheumatoid arthritis 10% Spondylitis ankylopoetica 10%Inflammatory bowel disease 10% Drug interactionsInteractions play a role only in patients who use other drugs which may interact with biologicals. However, it is a relevant criterion from a formulary point of view.The score for each drug was dependent on the frequency and severity of observed drug interactions. Clinical efficacyClinical efficacy is always a very important selection criterion for any group of drugs. The score for each drug was derived from the results of double-blind comparative studies. SafetyThe extent and the severity of adverse effects is another important selection criterion for drugs. A distinction was made between "minor" side effects, such as gastrointestinal disturbances or skin reactions, occurring in clinical trials and severe or even life-threatening adverse reactions observed with large scale use of the drugs. The evaluation of the "minor" adverse effects was based on results of double blind comparative clinical studies.

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“…20,674 articles were found, of which 20,592 were excluded, resulting in 82 articles in which 41 clinical trials comparing biologics with placebo (six adalimumab 17,18,19,20,21,22,23,24,25,26,27 , three alefacept 28,29,30,31,32,33,34,35,36,37 , one briakinumab 38,39 , one certolizumab 40 , seven efalizumab 41,42,43,44,45,46,47,48,49,50,51 , eight etanercept 52,53,54,55,56,57,58,59,60,61,62,63,64 , one golimumab 65,66 , eight infliximab …”

Section: Study Selectionmentioning

confidence: 99%

Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials

et al. 2013

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Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials Eficácia e segurança de agentes biológicos no tratamento da psoríase moderada a grave: uma meta-análise de ensaios clínicos randomizados e controlados Eficacia y seguridad de los agentes biológicos en el tratamiento de la psoriasis moderada a severa: un metaanálisis de ensayos aleatorios y controlados

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Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial

Cited by 798 publications

References 14 publications

Impact of biologic therapies on risk of major adverse cardiovascular events in patients with psoriasis: systematic review and meta-analysis of randomized controlled trials

Impact of biologic therapies on risk of major adverse cardiovascular events in patients with psoriasis: systematic review and meta-analysis of randomized controlled trials

Biologicals in the Treatment of Plaque Psoriasis: Drug Selection by Means of the SOJA Method

Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials

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