Efficacy and safety of etanercept and adalimumab with and without a loading dose for psoriasis: A systematic review

Gilbert, Kathleen E.; Manalo, Iviensan F.; Wu, Jashin J.

doi:10.1016/j.jaad.2015.04.012

Cited by 9 publications

(5 citation statements)

References 4 publications

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“…11 A systematic review investigated the efficacy and safety of etanercept and adalimumab with and without a loading dose for the treatment of psoriasis. 12 The data for etanercept and adalimumab showed that starting with a loading dose resulted in a more rapid and higher percentage of psoriatic skin improvement only in the short term. Moreover, the authors observed a reduction of antiadalimumab antibody formation with the loading dose.…”

Section: Discussionmentioning

confidence: 99%

“…In particular, in the study by Gordon et al ., PASI 75 response rates at week 12 and 60 were achieved by 87% vs. 84%, and 83% vs. 80% of patients receiving ixekizumab with the loading dose vs. those who did not receive the loading dose, respectively; there was no significant difference between the two subgroups . A systematic review investigated the efficacy and safety of etanercept and adalimumab with and without a loading dose for the treatment of psoriasis . The data for etanercept and adalimumab showed that starting with a loading dose resulted in a more rapid and higher percentage of psoriatic skin improvement only in the short term.…”

Section: Discussionmentioning

confidence: 99%

“…Efficacy was evaluated by comparing the Psoriasis Area and Severity Index (PASI) 75 and PASI 90 response rates at week 8, 12, 16, 32 and 48. Results For patients who received the labelled dose vs. those who did not, PASI 75 response rates were achieved at week 8,12,16,32 and 48 by 60% vs. 40% (P < 0Á01), 72% vs. 61% (P < 0Á01), 77% vs. 75%, 85% vs. 77% and 79% vs. 78%, respectively. PASI 90 responses were achieved at the same time points by 45% vs. 31% (P < 0Á01), 49% vs. 40% (P < 0Á01), 54% vs. 47%, 55% vs. 47% and 57% vs. 54% for those who received the labelled dose vs. those who did not, respectively.…”

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confidence: 98%

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Efficacy of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis

et al. 2019

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Summary Background Secukinumab is administered at the labelled dose of 300 mg at weeks 0, 1, 2, 3, 4 (loading dose) and every 4 weeks thereafter. Objectives To investigate the efficacy of secukinumab administered without the initial loading dose in patients with psoriasis. Methods This was a retrospective observational study including adult patients with psoriasis (n = 156) treated with secukinumab 300 mg administered either according to the labelled dose (n = 75) or without the initial loading dose (n = 81). Efficacy was evaluated by comparing the Psoriasis Area and Severity Index (PASI) 75 and PASI 90 response rates at week 8, 12, 16, 32 and 48. Results For patients who received the labelled dose vs. those who did not, PASI 75 response rates were achieved at week 8, 12, 16, 32 and 48 by 60% vs. 40% (P < 0·01), 72% vs. 61% (P < 0·01), 77% vs. 75%, 85% vs. 77% and 79% vs. 78%, respectively. PASI 90 responses were achieved at the same time points by 45% vs. 31% (P < 0·01), 49% vs. 40% (P < 0·01), 54% vs. 47%, 55% vs. 47% and 57% vs. 54% for those who received the labelled dose vs. those who did not, respectively. A greater proportion of patients receiving secukinumab without the loading dose discontinued treatment because of inefficacy (25% vs. 13%, P < 0·05), particularly those with body weight greater than 80 kg. Conclusions Secukinumab administered without the loading dose is associated with a higher proportion of primary inefficacy, and achieved inferior results compared with the labelled dose at week 8 and week 12, but showed similar efficacy thereafter. What's already known about this topic? Secukinumab is an interleukin (IL)‐17A inhibitor for chronic plaque psoriasis administered by subcutaneous injections at the labelled dose of 300 mg at weeks 0, 1, 2, 3, 4 (loading dose) and every 4 weeks thereafter (maintenance dose). Dose adjustment is common in clinical practice, and can consist of dose reduction when a prolonged remission is obtained or a dose increase in order to improve efficacy. What does this study add? The efficacy of secukinumab administered without the initial weekly loading dose was significantly inferior compared with the labelled dose in the short term, but was similar after week 16 and up to week 48. A greater proportion of patients receiving secukinumab without the loading dose showed primary inefficacy, particularly those with body weight greater than 80 kg.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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confidence: 98%

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Efficacy of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis

et al. 2019

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“…Our work focused on AIRDs alone and the question is whether the effects of dose loading are comparable to other disease entities in which bDMARDs are prescribed, such as in psoriasis, IBD, or ophthalmological conditions. In psoriasis, for example, a review has been performed describing the efficacy and safety of dose loading of etanercept and adalimumab [ 18 ]. This study concluded that for etanercept dose loading resulted in more rapid and higher percentages of patients showing skin improvements, while for adalimumab there was insufficient evidence.…”

Section: Discussionmentioning

confidence: 99%

The pharmacological and clinical aspects behind dose loading of biological disease modifying anti-rheumatic drugs (bDMARDs) in auto-immune rheumatic diseases (AIRDs): rationale and systematic narrative review of clinical evidence

et al. 2020

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Background Dose loading of biological disease modifying anti-rheumatic drugs (bDMARDs) in auto-immune rheumatic diseases (AIRDs) is performed to achieve steady state drug concentrations earlier after treatment start compared to dosing regimens without loading. Although loading inherently results in increased costs, treatment targets in terms of reduced disease activity may be achieved at an earlier state. It is an interesting topic that, surprisingly, has not received much attention in literature. Methods In this review, we aimed at providing a theoretical description of the pharmacodynamic / -kinetic rationale for dose loading of bDMARDs in AIRDs and to systematically review the clinical evidence on the effectiveness of dose loading on disease activity in AIRDs. Results Only a small number of studies ( n = 5) has been published comparing the effectiveness of dose loading versus a regimen without dose loading of bDMARDs in AIRDs, addressing abatacept ( n = 2), certolizumab pegol ( n = 1), and secukinumab (n = 2). These studies provide insufficient evidence on superiority of dose loading in terms of disease activity compared to a dosing regimen without loading, while safety issues might be comparable. Conclusions Although dose loading is commonly adopted for several bDMARDs in AIRDs, scientific evidence on its effectiveness and safety is surprisingly scarce and does not suggest superiority compared to a regimen without dose loading. More research in this field, also with regard to the pharmaco-economic consequences of dose loading, is urgently needed.

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“…1 Despite widespread use, there is limited evaluation of whether drug regimens with loading doses yield better clinical outcomes compared with nonloading dose regimens, especially given their increased cost and resulting pressure on physicians from payors to forego them. [2][3][4] Published reasons for loading dose use include the need for more drug to achieve than maintain disease control, to neutralize or prevent the formation of anti-drug antibodies and to achieve therapeutic drug levels in protein-losing enteropathies, like Crohn's disease and ulcerative colitis. 1,5,6 However, there is no clear pattern of biologic therapy use, as regimens with loading doses are recommended for some biologics but not others, sometimes independent of half-life and drug.…”

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confidence: 99%

Dermatologic inflammatory conditions require high loading and maintenance doses of biologic therapy

Greif

Porter

Kimball

2022

Acad Dermatol Venereol

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Biologic therapies are used to treat multiple inflammatory diseases, including psoriasis. In most regimens, loading doses are used to reduce the time to therapeutic drug levels and, ideally, shorten the time to clinical response. 1 Despite widespread use, there is limited evaluation of whether drug regimens with loading doses yield better clinical outcomes compared with nonloading dose regimens, especially given their increased cost and resulting pressure on physicians from payors to forego them. [2][3][4] Published reasons for loading dose use include the need for more drug to achieve than maintain disease control, to neutralize or prevent the formation of anti-drug antibodies and to achieve therapeutic drug levels in protein-losing enteropathies, like Crohn's disease and ulcerative colitis. 1,5,6 However, there is no clear pattern of biologic therapy use, as regimens with loading doses are recommended for some biologics but not others, sometimes independent of half-life and drug. 1 This study seeks Table 1 FDA-approved biologic therapy regimens by therapy and indication 5,7 Adalimumab PsO/Uveitis: 80 mg initial dose, followed by 40 mg every other wk starting one wk after initial dose PsA/RA/AS: 40 mg every other wk CD/UC/HS: Day 1: 160 mg, day 15: 80 mg, day 29: maintenance 40 mg every other wk Adalimumab-adbm PsO: 80 mg initial dose, followed by 40 mg every other wk starting one wk after initial dose PsA/RA/AS: 40 mg every other wk CD/UC: Day 1: 160 mg, day 15: 80 mg, day 29: maintenance 40 mg every other wk BrodalumabPsO: 210 mg at wks 0, 1 and 2, followed by 210 mg every 2 wks Certolizumab pegolPsO: 400 mg every other wk PsA/RA: 400 mg initially and at wks 2 and 4, followed by 200 mg every other wk AS/nr-axSpA: 400 mg initially at wks 2 and 4, followed by 200 mg every other wk or 400 mg every 4 wks CD: 400 mg initially and at wks 2 and 4, followed by 400 mg every 4 wks Etanercept PsO: 50 mg twice wkly for 3 months, followed by 50 mg once wkly PsA/RA: 50 mg once wkly with or without methotrexate AS: 50 mg once wkly Etanercept-szzs PsO: 50 mg twice wkly for 3 months, followed by 50 mg once wkly

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Efficacy and safety of etanercept and adalimumab with and without a loading dose for psoriasis: A systematic review

Cited by 9 publications

References 4 publications

Efficacy of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis

Efficacy of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis

The pharmacological and clinical aspects behind dose loading of biological disease modifying anti-rheumatic drugs (bDMARDs) in auto-immune rheumatic diseases (AIRDs): rationale and systematic narrative review of clinical evidence

Dermatologic inflammatory conditions require high loading and maintenance doses of biologic therapy

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