Investigator-initiated, open-label trial of ustekinumab for the treatment of moderate-to-severe palmoplantar psoriasis

Au, Shiu Chung; Goldminz, Ari M.; Kim, Noori; Dumont, Nicole; Michelon, Melissa; Volf, Eva; Hession, Meghan T.; Lizzul, Paul F.; Andrews, Israel D.; Kerensky, Todd; Wang, Andrew; Yaniv, Shimrat; Gottlieb, Alice B.

doi:10.3109/09546634.2012.672710

Cited by 58 publications

(74 citation statements)

References 53 publications

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“…The SD for changes in DLQI scores is approximately 7 units; 16 thus, if 80% of the 210 patients scheduled for enrollment ( n = 167) were evaluable for the analysis of change in DLQI scores from baseline, then the distance from the boundaries of the two‐sided 95% confidence interval (CI) to the point estimate would be 1.07 units.…”

Section: Methodsmentioning

confidence: 99%

Observational study on quality of life, safety, and effectiveness of first‐line cetuximab plus chemotherapy in KRAS wild‐type metastatic colorectal cancer patients: the ObservEr Study

Pinto¹,

Fabio

Rosati

et al. 2016

Cancer Medicine

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Cetuximab improves efficacy when added to chemotherapy for metastatic colorectal cancer (mCRC). Effective management of skin reactions from cetuximab improves quality of life (QoL), and treatment compliance in clinical trials. No data are available from real‐world settings. The ObservEr observational, multicenter, prospective study evaluated QoL, the incidence of skin reactions, and management of chemotherapy plus cetuximab in first‐line for mCRC. The primary endpoint was QoL measured with the Dermatology Life Quality Index (DLQI) and EORTC QLQ‐C30. Secondary endpoints were the incidence of skin and serious adverse events, median overall and progression‐free survival, tumor response, and resection rates. Between May 2011 and November 2012, 228 patients with KRASwt mCRC were enrolled at 28 Italian centers, 225 evaluable, median age 65 years. QoL did not change during treatment and was not affected by the choice of prophylactic or reactive skin management. The incidence of cetuximab‐specific grade ≥3 skin reactions was 14%, with no grade 4/5 events. Skin reactions correlated with survival (P = 0.016), and their incidence was influenced by chemotherapy regimen (oxaliplatin vs. irinotecan—Incidence rate ratio [IRR] 1.72, P < 0.0001) and gender (male vs. female—IRR 1.38, P = 0.0008). Compliance at first postbaseline evaluation was 97.75%. Median overall survival was 23.6 months, median progression‐free survival 8.3 months. Cetuximab plus chemotherapy did not compromise QoL in the routine clinical setting when patients receive close monitoring plus prophylactic or reactive management of skin reactions. We observed the same correlation between overall survival (OS) and skin reactions reported in controlled clinical trials, also in this setting.

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Section: Methodsmentioning

confidence: 99%

Observational study on quality of life, safety, and effectiveness of first‐line cetuximab plus chemotherapy in KRAS wild‐type metastatic colorectal cancer patients: the ObservEr Study

Pinto¹,

Fabio

Rosati

et al. 2016

Cancer Medicine

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“…So war in einer Studie gegenüber Placebo kein Vorteil zu sehen [65]. In einer anderen Studie zeigten sich dagegen bei einer Dosis von 90 mg bessere Erfolge [68]. [74]).…”

Section: Introductionunclassified

Pustulöse Psoriasis

et al. 2016

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A number of pustular skin diseases share clinical, pathogenetic, and epidemiological aspects with plaque-type psoriasis, and their classification as a separate clinical entity or as a subtype of psoriasis remains controversial, which is also reflected in the multitude of their names. They include generalized pustular psoriasis with its subtypes, acrodermatitis continua suppurativa (Hallopeau), acute pustulosis palmopantaris, palmoplantar pustular psoriasis, and pustular variants of a mostly TNF-blocker triggered paradoxical psoriasiform dermatitis. In this article, the epidemiology, clinical picture, pathogenesis, genetics, and therapy of these pustular skin diseases are described.

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“…Au and colleagues studied the role of UST in 20 subjects with moderate-to-severe psoriasis of the palms and soles [Au et al 2013]. They treated patients who have previously failed topical steroids with UST at weeks 0, 4 and 16.…”

Section: Efficacymentioning

confidence: 99%

“…At 24 weeks, mean values showed 56% improvement in Dermatology Life Quality Index, and 34% improvement in pain Visual Analogue Scale score (all p < 0.05). It was concluded that UST dosed at 90 mg is effective in controlling signs and symptoms of palmoplantar psoriasis [Au et al 2013]. …”

Section: Efficacymentioning

confidence: 99%

Ustekinumab in the treatment of psoriatic arthritis: latest findings and clinical potential

Gottlieb

Narang

2013

Therapeutic Advances in Musculoskeletal

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Ustekinumab (UST) is a fully human immunoglobulin G1κ (IgG1κ) monoclonal antibody against common sub-unit p40 of interleukin-12 (IL-12) and interleukin-23 (IL-23). IL-12 and IL-23 are essential components of the Th1 and Th17 inflammatory pathways, respectively, and are the key mediators of psoriasis. Psoriatic arthritis (PsA), an important systemic inflammatory disorder, has similar pathogenesis to psoriasis. Many of PsA patients do not respond to tumor necrosis factor (TNF) inhibitor therapy, highlighting the need for additional treatment modalities with distinct mechanisms of action. Also, many patients stop responding to these agents after a certain period of use. A significant number of patients have a recurrent course or a persistent disease process. To meet these challenges a new agent working on different inflammatory aspect of PsA is needed. UST has been demonstrated to be effective, safe on short-term use and convenient in the treatment of plaque psoriasis and PsA. Long-term safety is still a concern. Until recently, the exact role of UST in the management of PsA had not been very clear. This article reviews the mechanism of action, pharmacokinetics, efficacy, safety profile and the clinical potential of UST in patients with PsA. We also discuss the three major trials conducted to show the efficacy and safety of UST in PsA.

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Investigator-initiated, open-label trial of ustekinumab for the treatment of moderate-to-severe palmoplantar psoriasis

Abstract: This study demonstrates that ustekinumab dosed at 90 mg is effective in controlling signs and symptoms of palmoplantar psoriasis.

Cited by 58 publications

References 53 publications

Observational study on quality of life, safety, and effectiveness of first‐line cetuximab plus chemotherapy in KRAS wild‐type metastatic colorectal cancer patients: the ObservEr Study

Observational study on quality of life, safety, and effectiveness of first‐line cetuximab plus chemotherapy in KRAS wild‐type metastatic colorectal cancer patients: the ObservEr Study

Pustulöse Psoriasis

Ustekinumab in the treatment of psoriatic arthritis: latest findings and clinical potential

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