Amy S. Paller, MD, Elaine C. Siegfried, MD, David M

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Presentation transcript:

Long-term safety and efficacy of etanercept in children and adolescents with plaque psoriasis Amy S. Paller, MD, Elaine C. Siegfried, MD, David M. Pariser, MD, Kara Creamer Rice, MS, Mona Trivedi, MD, Jan Iles, MD, David H. Collier, MD, Greg Kricorian, MD, Richard G. Langley, MD Journal of the American Academy of Dermatology Volume 74, Issue 2, Pages 280-287.e3 (February 2016) DOI: 10.1016/j.jaad.2015.09.056 Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Fig 1 Plaque psoriasis, patient disposition. OLE, Open-label extension. Journal of the American Academy of Dermatology 2016 74, 280-287.e3DOI: (10.1016/j.jaad.2015.09.056) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Fig 2 Plaque psoriasis, efficacy outcomes in children and adolescents treated with etanercept. The percentage of patients with 75% improvement in Psoriasis Area and Severity Index score (PASI 75) (A), 90% improvement in Psoriasis Area and Severity Index score (PASI 90) (B), and static physician global assessment (sPGA) status of clear/almost clear (score 0/1) (C) from week 96 through week 264 is shown. The number of patients with available data is shown below each graph. Data are reported as observed, without imputation for missing data. Error bars represent 95% confidence interval (CI). Journal of the American Academy of Dermatology 2016 74, 280-287.e3DOI: (10.1016/j.jaad.2015.09.056) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Supplemental Fig 1 Study schema. aDuring the double-blind treatment phase, patients were randomized (1:1) to etanercept or placebo weekly. After week 4, patients could enter an escape group and receive open-label etanercept through week 12 if their Psoriasis Area and Severity Index (PASI) score either increased by >50% over baseline and by a minimum of 4 points at 1 visit or increased by >25% and by a minimum of 4 points at each of 2 consecutive visits. bAll patients, including those who entered the escape group during weeks 4 through 12, received open-label etanercept. Patients who did not achieve a 50% improvement in PASI score (PASI 50) at week 24 or a 75% improvement in PASI score (PASI 75) at week 36 could discontinue the study or add topical standard-of-care therapy and continue to receive open-label etanercept until week 48. cAt week 36, patients with a PASI 50 at week 24 or PASI 75 at week 36 were randomized (1:1) to etanercept or placebo. Patients who lost their PASI 75 response resumed open-label etanercept through week 48. EOS, End of study; OLE, open-label extension. Journal of the American Academy of Dermatology 2016 74, 280-287.e3DOI: (10.1016/j.jaad.2015.09.056) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Supplemental Fig 2 The 75% improvement in Psoriasis Area and Severity Index score (PASI 75) and 90% improvement in Psoriasis Area and Severity Index score (PASI 90) responses in patients who developed anti-etanercept antibodies. The percentage of patients who achieved PASI 75 (A) and PASI 90 (B) response from baseline of the parent study is shown for patients who developed anti-etanercept antibodies (open circles) and all patients (closed diamonds). No patient developed neutralizing antibodies. CI, Confidence interval. Journal of the American Academy of Dermatology 2016 74, 280-287.e3DOI: (10.1016/j.jaad.2015.09.056) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions

Supplemental Fig 3 The percentage of patients categorized as healthy weight (body mass index [BMI] 5th-84th percentile∗; open diamonds), overweight (BMI 85th-94th percentile; gray squares), and obese (BMI ≥95th percentile; black triangles) who achieved a 75% improvement in Psoriasis Area and Severity Index score (PASI 75) response from baseline of the parent study. ∗Barlow SE; Expert Committee. Expert Committee recommendations regarding the prevention, assessment, and treatment of child and adolescent overweight and obesity: summary report. Pediatrics 2007;120(Suppl):S164-92. CI, Confidence interval. Journal of the American Academy of Dermatology 2016 74, 280-287.e3DOI: (10.1016/j.jaad.2015.09.056) Copyright © 2015 American Academy of Dermatology, Inc. Terms and Conditions