Drug Survival Studies in Dermatology:Principles, Purposes, and Pitfalls

Reek, J.M.P.A. van den; Kievit, Wietske; Gniadecki, Robert; Goeman, Jelle J.; Zweegers, Jeffrey; Kerkhof, P.C.M. van de; Seyger, M.M.B.; Jong, E.M.G.J. de

doi:10.1038/jid.2015.171

Cited by 99 publications

(117 citation statements)

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“…The latter approach in measuring the effectiveness of biological therapies in psoriasis emerged in several publications in recent years [16, 82]. This outcome, often called drug survival (or with different synonyms, such as drug persistence or drug longevity), is an overall marker of treatment success and treatment adherence, as it represents information on drug efficacy, drug safety, and patient satisfaction.…”

Section: Discussionmentioning

confidence: 99%

“…Among other limitations in interpreting drug survival results, biological therapies with a longer half-life are more likely to be associated with a higher drug survival than therapies with a shorter half-life when adopting the Kaplan-Meier approach. However, as recently discussed [16, 28], different definitions of the grace period should be considered within each study according to the half-life of biological therapies. Sensitivity analyses may be used to test the robustness of the estimates.…”

Section: Discussionmentioning

confidence: 99%

“…In interpreting evidence based on biological drug survival in psoriatic patients some limitations should be acknowledged [16, 82, 87]. There is no recognized uniform definition on failure (i.e., drug discontinuation) and on censored patients.…”

Section: Discussionmentioning

confidence: 99%

“…This conclusion was based on improvement of the clinical outcome Psoriasis Area and Severity Index (PASI) response only. However, considering only a clinical outcome to measure the effectiveness of biological therapies in daily practice may not reflect the patients’ perception of treatment success [15, 16]. Recently, several articles proposed an alternative outcome for evaluating the effectiveness of biological therapies, called drug survival (or different synonyms, such as drug persistence) [16].…”

Section: Introductionmentioning

confidence: 99%

“…However, considering only a clinical outcome to measure the effectiveness of biological therapies in daily practice may not reflect the patients’ perception of treatment success [15, 16]. Recently, several articles proposed an alternative outcome for evaluating the effectiveness of biological therapies, called drug survival (or different synonyms, such as drug persistence) [16]. This is often used as a drug effectiveness measure in observational studies that provide insight into the delivery of care in routine practice to all patients, including elderly subjects and those with comorbidities, provide information for gaps of knowledge from efficacy to effectiveness of new therapies in the disease state population, provide insight into short- and long-term safety profiles in routine practice, and address questions that have not been evaluated in an RCT.…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness End Points in Real-World Studies on Biological Therapies in Psoriasis: Systematic Review with Focus on Drug Survival

Costanzo¹,

Malara²,

Pelucchi³

et al. 2018

Dermatology

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Psoriasis is a complex and chronic disease, and, in most cases, therapies are required during all patients’ lifetime. The efficacy and safety profiles of biological therapies are well established, but their effectiveness is still open to discussion. We performed a systematic review to summarize how the effectiveness of biological therapies for psoriasis is measured in real-world studies and to understand whether drug survival, a recent alternative outcome to clinical ones, is a recurrent and valid outcome of effectiveness. In March 2017, we searched for quantitative epidemiological data of psoriasis treatments using PubMed/Medline and EMBASE, and we included 65 publications. The retrospective study design (37%) was most frequent, followed by prospective registries (29%), prospective studies (19%), and retrospective administrative databases/claims. Drug survival was reported in over 60% of prospective registries and retrospective studies, and less frequently in prospective studies. A general consensus emerged in the definition of drug survival as the time patients remain under treatment with a specific therapy, and in its interpretation as an overall marker of treatment success and treatment adherence, as it represents simultaneously information on drug efficacy, drug safety, and patient satisfaction. In conclusion, notwithstanding some limitations, drug survival is a useful measurement of biological therapy effectiveness for psoriasis in daily practice. Its major advantage is that it can be computed also in already collected databases without any specific clinical information on psoriasis. This outcome, combined with evidence on clinical markers of effectiveness, can contribute to better understanding the performance of this expensive class of drugs.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Effectiveness End Points in Real-World Studies on Biological Therapies in Psoriasis: Systematic Review with Focus on Drug Survival

Costanzo¹,

Malara²,

Pelucchi³

et al. 2018

Dermatology

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A Comparison of Psoriasis Severity in Pediatric Patients Treated With Methotrexate vs Biologic Agents

et al. 2020

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and the European Working Group on Pediatric Psoriasis IMPORTANCE Few studies have compared the use of methotrexate and biologics, the most commonly used systemic medications for treatment of moderate to severe psoriasis in children.OBJECTIVE To assess the real-world, 6-month reduction in psoriasis severity and long-term drug survival (rate and duration of adherence to a specific drug) of methotrexate vs biologics in plaque psoriasis in children. DESIGN, SETTING, AND PARTICIPANTSA retrospective medical records review was conducted at 20 European and North American centers. Treatment response was based on site-reported Psoriasis Area and Severity Index (PASI) and/or Physician Global Assessment (PGA) scores at baseline and within the first 6 months of treatment. Participants included all 234 consecutively seen children with moderate to severe psoriasis who

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Outcomes Following a Mandatory Nonmedical Switch From Adalimumab Originator to Adalimumab Biosimilars in Patients With Psoriasis

et al. 2021

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MAIN OUTCOMES AND MEASURESThe primary outcome was 1-year drug retention in patients switching to adalimumab biosimilars compared with patients treated with adalimumab originator. Crude and adjusted retention rates for the adalimumab biosimilar cohort were compared with the adalimumab originator cohort with Cox proportional hazards regression using robust variance.RESULTS A total of 348 patients were included in the adalimumab biosimilar cohort (mean [SD] age, 52.2 [13.6] years; 251 [72.1%] male) and 378 patients in the adalimumab originator cohort (mean [SD] age, 51.1 [14.1] years; 272 [72.0%] male). The 1-year drug retention rates were 92.0% (95% CI, 89.0%-94.9%) for the adalimumab biosimilar cohort and 92.1% (95% CI, 89.4%-94.8%) for the adalimumab originator cohort. Similar hazard ratios were observed between the 2 cohorts. The crude hazard ratios were 1.02 (95% CI, 0.61-1.70; P = .94) for all causes of drug discontinuation, 0.82 (95% CI, 0.39-1.73; P = .60) for insufficient effect, and 1.41 (95% CI, 0.52-3.77; P = .50) for adverse events for the adalimumab biosimilar cohort when compared with the adalimumab originator cohort.

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Drug Survival Studies in Dermatology:Principles, Purposes, and Pitfalls

Cited by 99 publications

References 9 publications

Effectiveness End Points in Real-World Studies on Biological Therapies in Psoriasis: Systematic Review with Focus on Drug Survival

Effectiveness End Points in Real-World Studies on Biological Therapies in Psoriasis: Systematic Review with Focus on Drug Survival

A Comparison of Psoriasis Severity in Pediatric Patients Treated With Methotrexate vs Biologic Agents

Outcomes Following a Mandatory Nonmedical Switch From Adalimumab Originator to Adalimumab Biosimilars in Patients With Psoriasis

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