Dose adjustment of biologic therapies for psoriasis in dermatological practice: a retrospective study

Esposito, Maria; Gisondi, Paolo; Conti, Andrea; Giunta, Alessandro; Giglio, Micol Del; Mercurio, Marco Di; Veneziano, Leonardo Squinello Nogueira; Ferrucci, G.; Bianchi, Luca; Chimenti, Sergio; Girolomoni, Giampiero

doi:10.1111/jdv.14145

Cited by 38 publications

(78 citation statements)

References 15 publications

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“…28 In clinical practice, this has resulted in dose optimization in order to increase or maintain clinical responses. [29][30][31] In particular, patients with higher BMI or body weight have demonstrated lower response rates with many fixed-dose biologic treatments, 5,6,[8][9][10][11][12] leading some biologics to be used with weight-based dosing or more frequent dosing schedules in order to achieve comparable efficacy in these patients. 7,32,33 Another factor that adversely affects efficacy with some biologics is prior exposure to or failure on a biologic.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of risankizumab in patients with moderate‐to‐severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa‐1 and UltIMMa‐2 studies

Strober

Menter

Gordon

et al. 2020

Acad Dermatol Venereol

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Background Risankizumab is a humanized IgG monoclonal antibody that selectively inhibits interleukin-23 through binding the p19 subunit. In Phase 3 trials, risankizumab demonstrated superior efficacy compared with adalimumab and ustekinumab in patients with moderate-to-severe plaque psoriasis. Here, we evaluated the impact of baseline characteristics on efficacy of risankizumab compared with ustekinumab in patients with moderate-to-severe plaque psoriasis. Methods This analysis included all patients initially randomized to risankizumab or ustekinumab from the replicate, double-blinded, randomized, placebo-controlled phase 3 trials, UltIMMa-1 (NCT02684370) and UltIMMa-2 (NCT02684357). Patients received either risankizumab (150 mg) or ustekinumab (weight-based; 45 or 90 mg per label) at weeks 0, 4, 16, 28 and 40. Efficacy was assessed as the proportion of patients achieving ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) at weeks 16 and 52 by baseline patient demographics, disease characteristics and prior biologic exposure. Mean per cent improvement in PASI was calculated by body weight and body mass index at week 52. Missing efficacy data were imputed as non-responders for categorical variables and last observation carried forward for continuous variables. Logistic regression analyses assessed for interactions between treatment and five independent variables (age, sex, weight, baseline PASI score and presence of psoriatic arthritis) at both weeks 16 and 52. Results Baseline patient demographics, disease characteristics and prior biologic exposure were similar between patients randomized to risankizumab (n = 598) and ustekinumab (n = 199). At weeks 16 and 52, risankizumab demonstrated superior efficacy compared with ustekinumab across these patient characteristics (P < 0.01). Logistic regression analyses demonstrated that risankizumab was superior to ustekinumab at weeks 16 and 52 in all models tested (P < 0.0001 for all). Conclusions Risankizumab demonstrated consistent and superior efficacy compared with ustekinumab regardless of patient demographics, disease characteristics or prior biologic exposure.

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Section: Discussionmentioning

confidence: 99%

Efficacy of risankizumab in patients with moderate‐to‐severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa‐1 and UltIMMa‐2 studies

Strober

Menter

Gordon

et al. 2020

Acad Dermatol Venereol

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“…Since this study only included clinical trials and not real-world evidence, only licensed doses of interventions were included. Several studies have been conducted which report that dose adjustments are used routinely in clinical practice (66,67).…”

Section: Strengths and Limitationsmentioning

confidence: 99%

Targeted therapies for patients with moderate-to-severe psoriasis: a systematic review and network meta-analysis of PASI response at 1 year

Yasmeen¹,

Sawyer²,

Malottki³

et al. 2020

Journal of Dermatological Treatment

102

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Purpose: To compare PASI outcomes of approved biologics and apremilast after 1 year of treatment. Methods: A systematic review identified RCTs and long-term extensions reporting PASI 75, 90, and 100 responses in adults with moderate-to-severe psoriasis. Data for analysis were modeled using a Bayesian multinomial likelihood model with probit link. Results: Twenty-eight studies reporting PASI responses were included in the network meta-analysis. Differences in study design led to a stepwise approach to synthesis, consisting of two analyses. The primary analysis included nine RCTs investigating comparative efficacy at 1 year. Results indicated risankizumab, brodalumab, and guselkumab were the most effective therapies, followed by ixekizumab and secukinumab; all demonstrated superiority to ustekinumab and etanercept. The secondary analysis extended the primary analysis with 19 further studies comparing active interventions to placebo outcomes extrapolated from induction. The interventions generating the highest PASI response were the same as the primary analysis. These therapies were more effective than apremilast, ustekinumab, adalimumab, certolizumab, etanercept, and infliximab. Conclusions: This NMA demonstrated that evaluated IL-17 and IL-23 inhibitors outperformed other biological therapies after 1 year. Risankizumab had a higher probability of achieving PASI outcomes than all other biologics, except brodalumab and guselkumab, where no significant difference could be concluded.

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“…However, studies have suggested that off-label dosing is commonly used in clinical practice, including a study which found an adjustment rate of 15.4%. 1 The aim of this study was to determine the frequency of off-label dosing in biologic-naive patients with psoriasis on etanercept, why these deviations occurred, and whether dosage adjustments may provide better clinical responses.…”

mentioning

confidence: 99%

Dosage Adjustments in Patients With Psoriasis on Etanercept: A Retrospective Chart Review

Lee

Thomas

Egeberg

et al. 2020

Journal of Psoriasis and Psoriatic Arthritis

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Etanercept, 1 of 11 Food and Drug Administration (FDA)–approved biologics used for the treatment for psoriasis, may often be used at off-label dosages. The aim of this retrospective chart review was to determine the frequency of off-label dosing in a single center and the reasons for these deviations as well as the outcomes. The results of this study demonstrated that nearly two-thirds (64.7%) of patients treated with etanercept had some form of dosage adjustment during their treatment course. Dosage increases were reported most often; all were due to inefficacy of etanercept at the FDA-approved dosing. Interruptions and decreased dosages were reported among 36.4% and 18.2% of patients, respectively. Our study confirms previous data suggesting use of off-label doses of etanercept is commonplace, and a trial of increased etanercept dosing may be worthwhile for biologic-naive patients achieving suboptimal clinical response on standard dosing before switching to another biologic.

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Dose adjustment of biologic therapies for psoriasis in dermatological practice: a retrospective study

Abstract: Dose adjustment is a common clinical practice, consisting of frequent dose reduction when a disease prolonged remission is obtained or dose increase to improve efficacy on Pso and PsA disease parameters.

Cited by 38 publications

References 15 publications

Efficacy of risankizumab in patients with moderate‐to‐severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa‐1 and UltIMMa‐2 studies

Efficacy of risankizumab in patients with moderate‐to‐severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa‐1 and UltIMMa‐2 studies

Targeted therapies for patients with moderate-to-severe psoriasis: a systematic review and network meta-analysis of PASI response at 1 year

Dosage Adjustments in Patients With Psoriasis on Etanercept: A Retrospective Chart Review

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