Etanercept as Monotherapy in Patients with Psoriasis

Leonardi, Craig L.; Powers, Jerold L.; Matheson, Robert; Goffe, Bernard S.; Zitnik, Ralph; Wang, Andrea; Gottlieb, Alice B.

doi:10.1056/nejmoa030409

Cited by 1,089 publications

(990 citation statements)

References 19 publications

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“…Significant skin responses were also observed early in treatment; patients treated with adalimumab achieved the PASI50 response after 2 weeks and the PASI75 response after 4 weeks, with peak responses at about week 16. This difference in response rates between the joints and skin is consistent with the evidence showing that, for some TNF antagonists, full response in the skin may require a higher dose and take longer to achieve than in the joints (20,22,41,42). This suggests that sites of inflammation in psoriatic skin might have a different biologic response to TNF antagonists than that exhibited by such sites in the joints, as has also been suggested for the intestinal response in Crohn's disease (43)(44)(45).…”

Section: Discussionsupporting

confidence: 86%

Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double‐blind, randomized, placebo‐controlled trial

Mease

Gladman

Ritchlin

et al. 2005

Arthritis & Rheumatism

842

629

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Objective. Adalimumab, a fully human, antitumor necrosis factor monoclonal antibody, was evaluated for its safety and efficacy compared with placebo in the treatment of active psoriatic arthritis (PsA).Methods. Patients with moderately to severely active PsA and a history of inadequate response to nonsteroidal antiinflammatory drugs were randomized to receive 40 mg adalimumab or placebo subcutaneously every other week for 24 weeks. Study visits were at baseline, weeks 2 and 4, and every 4 weeks thereafter. The primary efficacy end points were the American College of Rheumatology 20% improvement (ACR20) response at week 12 and the change in the modified total Sharp score of structural damage at week 24. Secondary end points were measures of joint disease, disability, and quality of life in all patients, as well as the severity of skin disease in those patients with psoriasis involving at least 3% of body surface area.Results. At week 12, 58% of the adalimumabtreated patients (87 of 151) achieved an ACR20 response, compared with 14% of the placebo-treated patients (23 of 162) (P < 0.001). At week 24, similar ACR20 response rates were maintained and the mean change in the modified total Sharp score was ؊0.2 in patients receiving adalimumab and 1.0 in those receiving placebo (P < 0.001). Among the 69 adalimumabtreated patients evaluated with the Psoriasis Area and Severity Index (PASI), 59% achieved a 75% PASI improvement response at 24 weeks, compared with 1% of the 69 placebo-treated patients evaluated (P < 0.001). Disability and quality of life measures were also significantly improved with adalimumab treatment compared with placebo. Adalimumab was generally safe and welltolerated.Conclusion. Adalimumab significantly improved joint and skin manifestations, inhibited structural changes on radiographs, lessened disability due to joint damage, and improved quality of life in patients with moderately to severely active PsA.Psoriatic arthritis (PsA) is a chronic, inflammatory arthritis occurring in individuals with psoriasis. Psoriasis occurs in 2-3% of the US population (1). The reported range of prevalence of PsA in patients with psoriasis is 6-39%, depending on the population studied

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Section: Discussionsupporting

confidence: 86%

Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double‐blind, randomized, placebo‐controlled trial

Mease

Gladman

Ritchlin

et al. 2005

Arthritis & Rheumatism

842

629

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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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“…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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Etanercept as Monotherapy in Patients with Psoriasis

Abstract: The treatment of psoriasis with etanercept led to a significant reduction in the severity of disease over a period of 24 weeks.

Cited by 1,089 publications

References 19 publications

Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double‐blind, randomized, placebo‐controlled trial

Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double‐blind, randomized, placebo‐controlled trial

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

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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