Practical experience of ustekinumab in the treatment of psoriasis: experience from a multicentre, retrospective case cohort study across the U.K. and Ireland

Laws, Philip; Downs, A. M. R.; Parslew, Richard; Dever, Bernadette; Smith, Catherine; Barker, Jonathan; Moriarty, B.; Murphy, Ruth; Kirby, Brian; Burden, A. D.; McBride, Sandy; Anstey, Alexander Vincent; O’Shea, Sally J.; Ralph, Nicola; Buckley, C.; Griffiths, C.E.M.; Warren, Richard B

doi:10.1111/j.1365-2133.2011.10638.x

Cited by 36 publications

(43 citation statements)

References 11 publications

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“…The efficacy results in our patients are consistent with those of a multicenter retrospective case cohort study from the UK and Ireland [5], with a PASI75 response rate of 63% at 16 weeks, and confirm those in a previous preliminary report [6], when 86% of patients achieved a PASI75 response at week 36. Our long-term results appear to be better than those in an Italian multicenter cohort of 79 patients, with a PASI75 response rate of 58% at 7 months [7], but are consistent with those of the open label extension of the PHOENIX trials up to 3 years [1], when PASI75 response rates were maintained through year 3 (45-mg group: 63%; 90-mg group: 72%).…”

Section: Discussionsupporting

confidence: 80%

“…Body fat (or perhaps central fat) might impair the achievement of the maximum therapeutic effect of ustekinumab despite weight-based dosing, but further data from pivotal trials and real world cohorts are required to prove this hypothesis. On the other hand, lower response rates have been associated with extremely heavy weight in clinical practice: PASI75 response rates have been reported to be 75.0 and 55.6% for weight groups 100-110 and >110 kg, respectively, but this is an unlikely explanation for our findings, since the latter group accounted for only 3 out of 11 patients in our series [5]. …”

Section: Discussioncontrasting

confidence: 48%

“…Laws et al [5] observed a small, nonsignificant trend towards treatment failure at week 16, which in our cohort becomes statistically significant at both weeks 16 and 28. There was no difference in the PASI75 response rates between patients exposed to anti-TNF agents and anti-TNF naïve patients in a Danish series [14], but the mean observation time in this cohort was 143 days, and our results at week 28 and week 36 were not statistically significant either.…”

Section: Discussionmentioning

confidence: 81%

“…Patients in real life do differ from those enrolled in clinical trials [4], and cohort studies and registries are required to provide efficacy and safety data in clinical practice. The positive benefit-risk ratio and efficacy of ustekinumab in the real world have been confirmed in initial short-term studies, including a multicenter retrospective case cohort study from the UK and Ireland [5] and our previous report with 36 patients [6]. Efficacy results at 7 months of treatment are also available from an Italian multicenter cohort of 79 patients [7].…”

Section: Introductionmentioning

confidence: 74%

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Long-Term Efficacy, Safety and Drug Survival of Ustekinumab in a Spanish Cohort of Patients with Moderate to Severe Plaque Psoriasis

Puig¹,

Ruiz‐Salas²

2015

Dermatology

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Objective: To investigate the efficacy and safety of ustekinumab in clinical practice and the influence of several variables on response rates as well as on drug survival. Methods: Retrospectively collected efficacy and safety data of a cohort of 67 consecutive patients treated with ustekinumab for moderate to severe psoriasis for at least 28 weeks and a maximum of 3 years. Drug survival was analyzed by the Kaplan-Meier method with log-rank test. Results: PASI75 response rates were numerically higher in patients treated with 45 mg and patients naïve to tumor necrosis factor (TNF)-blocking agents, at all time points. Drug survival was not significantly affected by any variable. Conclusion: Male sex, weight >100 kg, obesity, and previous failure of one or more TNF inhibitors were associated with a diminished response to treatment. Obesity or previous exposure to anti-TNF agents was not associated with a diminished drug survival in this Spanish cohort.

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Section: Discussionsupporting

confidence: 80%

Section: Discussioncontrasting

confidence: 48%

Section: Discussionmentioning

confidence: 81%

Section: Introductionmentioning

confidence: 74%

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Long-Term Efficacy, Safety and Drug Survival of Ustekinumab in a Spanish Cohort of Patients with Moderate to Severe Plaque Psoriasis

Puig¹,

Ruiz‐Salas²

2015

Dermatology

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“…These trials led to the approval and post-trial use of ustekinumab as an available therapeutic option in daily clinical practice. However, there are few data from one center on patients treated continuously over 12 months outside randomized clinical trials [18,19] or long-term registries [20,21]. …”

Section: Introductionmentioning

confidence: 99%

What Happened after the Clinical Trials: Long-Term Safety and Efficacy of Ustekinumab in Daily Clinical Practice

Talamonti

Galluzzo²,

Bianchi³

et al. 2014

Dermatology

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Background: Ustekinumab has been investigated in patients with psoriasis by randomized clinical trials. There are few data on ustekinumab use under ‘real life' conditions outside long-term registries. Objective: The aim of our study was to evaluate the efficacy and safety of ustekinumab as a long-term therapy in real life. Methods: We retrospectively analyzed the data of 71 patients who had been treated with ustekinumab up to 2 years. Efficacy data were analyzed both by ‘as treated' and ‘intention to treat-last observation carried forward'. Results: A significant improvement in the Psoriasis Area and Severity Index score was observed at 4 weeks and further improvements were observed throughout the treatment. Adverse events were generally mild. Conclusions: In routine administration ustekinumab seems to be more efficient than reported by randomized clinical trials. Our results are encouraging and can answer the patients' biggest concern on whether ustekinumab is an effective and safe drug for long-term use.

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Association of Serum Ustekinumab Levels With Clinical Response in Psoriasis

et al. 2019

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; for the British Association of Dermatologists Biologic and Immunomodulators Register (BADBIR) Study Group and the Psoriasis Stratification to Optimise Relevant Therapy (PSORT) Consortium IMPORTANCE High-cost biologic therapies have transformed the management of immune-mediated inflammatory diseases. To optimize outcomes and reduce costs, dose adjustment informed by measurement of circulating drug levels has been shown to be effective in various settings. However, limited evidence exists for this approach with the interleukin 12 and interleukin 23 inhibitor ustekinumab. OBJECTIVE To evaluate clinical utility of therapeutic drug monitoring for ustekinumab in patients with psoriasis. DESIGN, SETTING, AND PARTICIPANTS A prospective observational cohort of 491 adults with psoriasis was recruited to the multicenter Biomarkers of Systemic Treatment Outcomes in Psoriasis study within the British Association of Dermatologists Biologic and Immunomodulators Register from June 2009 to December 2017; samples from some patients were taken between 2009 and 2011 as part of a pilot study with the same inclusion criteria. EXPOSURE Serum ustekinumab level measured at any point during the dosing cycle using an enzyme-linked immunosorbent assay. MAIN OUTCOMES AND MEASURES Disease activity measured using the Psoriasis Area and Severity Index (PASI) score. Treatment response outcomes were PASI75 (75% reduction in PASI score from baseline [primary outcome]), PASI90 (90% reduction of PASI score from baseline), and absolute PASI score of 1.5 or less. RESULTS A total of 491 patients (171 women and 320 men; mean [SD] age, 45.7 [12.8] years) had 1 or more serum samples (total, 853 samples obtained 0-56 weeks from start of treatment) and 1 or more PASI scores within the first year of treatment. Antidrug antibodies were detected in only 17 of 490 patients (3.5%). Early measured drug levels (1-12 weeks after starting treatment) were associated with PASI75 response 6 months after starting treatment (odds ratio, 1.38; 95% CI, 1.11-1.71) when adjusted for baseline PASI score, age, and ustekinumab dose. However, this finding was not consistent across the other PASI outcomes (PASI90 and PASI score of Յ1.5). CONCLUSIONS AND RELEVANCE This real-world study provides evidence that measurement of early serum ustekinumab levels could be useful to direct the treatment strategy for psoriasis. Adequate drug exposure early in the treatment cycle may be particularly important in determining clinical outcome.

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Practical experience of ustekinumab in the treatment of psoriasis: experience from a multicentre, retrospective case cohort study across the U.K. and Ireland

Abstract: Ustekinumab is a novel biologic agent for psoriasis. When used in everyday clinical practice it demonstrates high levels of short-term therapeutic efficacy with an acceptable short-term safety profile.

Cited by 36 publications

References 11 publications

Long-Term Efficacy, Safety and Drug Survival of Ustekinumab in a Spanish Cohort of Patients with Moderate to Severe Plaque Psoriasis

Long-Term Efficacy, Safety and Drug Survival of Ustekinumab in a Spanish Cohort of Patients with Moderate to Severe Plaque Psoriasis

What Happened after the Clinical Trials: Long-Term Safety and Efficacy of Ustekinumab in Daily Clinical Practice

Association of Serum Ustekinumab Levels With Clinical Response in Psoriasis

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