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Moderate to Severe Plaque Psoriasis
BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; PASI, Psoriasis Area and Severity Index.
Secondary endpoint; LOCF; FAS
aBaseline mean PASI scores: Placebo, 19; Otezla, 19.
LOCF, last observation carried forward.
Prespecified exploratory endpoint; LOCF; FAS
In the planned hierarchical statistical testing sequence for ESTEEM, efficacy analyses preceding ScPGA were statistically significant, allowing for control of the overall type 1 error rate at 0.05 significance level in analysis of ScPGA.
Baseline ScPGA ≥3.
BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; FAS, full analysis set; LOCF, last observation carried forward; ScPGA, Scalp Physician Global Assessment.
Prespecified exploratory endpoint; LOCF; FAS
In the planned hierarchical statistical testing sequence for ESTEEM, efficacy analyses preceding NAPSI were statistically significant, allowing for control of the overall type 1 error rate at 0.05 significance level in analysis of NAPSI.
In patients with nail psoriasis at baseline (NAPSI score ≥1; 66.1% [558/844]).
BID, twice daily; BL, baseline; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; FAS, full analysis set; LOCF, last observation carried forward; NAPSI, Nail Psoriasis Severity Index.
Secondary endpoint; LOCF; FAS
Pruritus was measured on a 100-mm VAS.
Baseline mean pruritus VAS scores (mm): Otezla, 66.2; Placebo, 65.2.
VAS, visual analog scale.
Secondary endpoint; LOCF; FAS
aBaseline mean DLQI scores: Placebo, 12.1; Otezla, 12.7.
BID, twice daily; DLQI, Dermatology Life Quality Index; FAS, full analysis set; LOCF, last observation carried forward.
Exploratory analysis; data as observed
FAS.
Week 16: primary endpoint; all other time points: exploratory endpoints.
Randomized treatment withdrawal phase (weeks 32 to 52) where additional psoriasis therapies, including topicals and/or phototherapy, could have been added to PASI‑75 nonresponders. Please see study design for additional information.
BID, twice daily; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; FAS, full analysis set; PASI, Psoriasis Area and Severity Index.
Exploratory analysis; data as observed
FAS.
Week 16: secondary endpoint; all other time points: exploratory endpoints.
Baseline mean PASI scores: Placebo, 19; Otezla, 19.
Randomized treatment withdrawal phase (weeks 32 to 52) where additional psoriasis therapies, including topicals and/or phototherapy, could have been added to PASI‑75 nonresponders. Please see study design for additional information.
Exploratory analysis; data as observed
FAS.
Baseline ScPGA ≥3.
Statistical analyses were conducted in a hierarchical manner for efficacy endpoints, including ScPGA score, to control the overall type 1 error rate.
Randomized treatment withdrawal phase (weeks 32 to 52) where additional psoriasis therapies, including topicals and/or phototherapy, could have been added to PASI‑75 nonresponders. Please see study design for additional information.
ScPGA, Scalp Physician Global Assessment.
Exploratory analysis; data as observed
FAS.
In patients with nail psoriasis at baseline (NAPSI score ≥1; 66.1% [558/844]).
Statistical analyses were conducted in a hierarchical manner for efficacy endpoints, including NAPSI score, to control the overall type 1 error rate.
Randomized treatment withdrawal phase (weeks 32 to 52) where additional psoriasis therapies, including topicals and/or phototherapy, could have been added to PASI‑75 nonresponders. Please see study design for additional information.
BL, baseline; NAPSI, Nail Psoriasis Severity Index.
Exploratory analysis; data as observed
FAS.
Baseline mean pruritus VAS scores (mm): Placebo, 65.2; Otezla, 66.2.
Week 16: secondary endpoint; all other timepoints: exploratory endpoints.
Randomized treatment withdrawal phase (weeks 32 to 52) where additional psoriasis therapies, including topicals and/or phototherapy, could have been added to PASI‑75 nonresponders. Please see study design for additional information.
VAS, visual analog scale.
Primary endpoint; ITT population; Ml analysis
ScPGA is evaluated on a 5-point scale (0 [clear], 1 [almost clear], 2 [mild], 3 [moderate], 4 [severe]), assessing the severity of erythema, scaling, and plaque elevation.
ScPGA response was defined as the proportion of patients achieving ScPGA response score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline (Otezla 43.3% vs placebo 13.7%; P<0.0001).
See Scalp Itch NRS Response and Whole Body Itch NRS Response at week 16
Exploratory analysis; ITT population; NRI analysis
Consider open-label extension (OLE) study limitations when interpreting results. The OLE study was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial.
Note: For each timepoint in a treatment arm, n = number of observed responded patients, N = total number of patients, and response rate (%) was calculated as 100*n/N. For assessments before week 16, N includes all randomized patients. For assessments after week 16, N includes only patients who entered the OLE phase.
ScPGA is evaluated on a 5-point scale (0 [clear], 1 [almost clear], 2 [mild], 3 [moderate], 4. [severe]), assessing the severity of erythema, scaling, and plaque elevation.
ScPGA response was defined as the proportion of patients achieving ScPGA response score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline.
Bars represent 2-sided 95% confidence interval.
BID, twice daily; ITT, intent to treat; MI, multiple imputation; NRI, nonresponder imputation; ScPGA, Scalp Physician Global Assessment; SE, standard error.
Secondary endpoint; ITT population; MI analysis
Patients rated their scalp itch on a scale of 0 (no itch) to 10 (worst imaginable itch).
Analyses were based on patients in the ITT population with baseline scalp itch NRS score ≥4.
Scalp itch NRS response was defined as a ≥4-point reduction (improvement) from baseline. At baseline, the mean scalp itch NRS score was 6.7, with scales ranging from 0 to 10.
Due to the MI method used to analyze the data, the n value for patients who achieved response may be in decimals.
Error bars represent 95% confidence interval.
ITT population; NRI analysis
Consider open-label extension (OLE) study limitations when interpreting results. The OLE study was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial.
Note: For each timepoint in a treatment arm, n = number of observed responded patients, N = total number of patients, and response rate (%) was calculated as 100*n/N. For assessments before week 16, N includes all randomized patients. For assessments after week 16, N includes only patients who entered the OLE phase.
Patients rated their scalp itch on a scale of 0 (no itch) to 10 (worst imaginable itch). Analyses were based on patients in the ITT population with baseline scalp itch NRS score ≥4.
Scalp itch NRS response was defined as a ≥4-point reduction (improvement) from baseline.
The placebo-controlled phase by visit (week 2, 4, 8, 12, 16) were secondary endpoints; OLE phase by visit (weeks 20, 24, 32) were exploratory endpoints.
Bars represent 2-sided 95% confidence interval.
BID, twice daily; ITT, intent to treat; MI, multiple imputation; NRI, nonresponder imputation; NRS, numeric rating scale; SE, standard error.
Secondary endpoint; ITT population; MI analysis
Patients rated their whole body itch on a scale of 0 (no itch) to 10 (worst imaginable itch). Analyses were based on patients in the ITT population with baseline whole body NRS score ≥4. At baseline, the mean whole body itch NRS score was 7.2, with the scales ranging from 0 to 10.
Whole body itch NRS response was defined as a ≥4-point reduction (improvement) from baseline.
Due to the MI method used to analyze the data, the n value for subjects who achieved response may be in decimals.
Error bars represent 95% confidence interval.
ITT population; NRI analysis
Consider open-label extension (OLE) study limitations when interpreting results. The OLE study was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial.
Note: For each timepoint in a treatment arm, n = number of observed responded patients, N = total number of patients, and response rate (%) was calculated as 100*n/N. For assessments before week 16, N includes all randomized patients. For assessments after week 16, N includes only patients who entered the OLE phase.
Patients rated their whole body itch on a scale of 0 (no itch) to 10 (worst imaginable itch). Analyses were based on patients in the ITT population with baseline whole body itch NRS score ≥4.
Whole body itch NRS response was defined as a ≥4-point reduction (improvement) from baseline.
The placebo-controlled phase by visit (weeks 2, 4, 8, 12, 16) were secondary endpoints; OLE phase by visit (weeks 20, 24, 32) were exploratory endpoints.
Bars represent 2-sided 95% confidence interval.
BID, twice daily; ITT, intent to treat; MI, multiple imputation; NRI, nonresponder imputation; NRS, numeric rating scale; SE, standard error.
Primary endpoint; LOCF; mITT
Patients were randomized and received ≥1 dose of study drug and had both baseline PASI and at least one post-treatment PASI evaluation.
LIBERATE, Evaluation in a Placebo-Controlled Study of Oral Apremilast and Etanercept in Plaque Psoriasis; LOCF, last observation carried forward; mITT, modified intent-to-treat; PASI, Psoriasis Area and Severity Index.
Prespecified exploratory analysis; LOCF; mITT
Baseline mean PASI scores: Placebo, 19.4; Otezla, 19.3.
Prespecified exploratory analysis; LOCF; mITT
Baseline ScPGA ≥3.
ScPGA, Scalp Physician Global Assessment.
Prespecified exploratory analysis; LOCF; mITT
In patients with a baseline value and at least one post-baseline value.
Baseline mean NAPSI scores: Placebo, 4.14; Otezla, 4.18.
BL, baseline; NAPSI, Nail Psoriasis Severity Index.
Prespecified exploratory analysis; LOCF; mITT
Pruritus was measured on a 100-mm VAS.
Baseline mean pruritus VAS scores (mm): Placebo, 62.5; Otezla, 62.6.
95% confidence interval.
BL, baseline; VAS, visual analog scale.
Secondary endpoint; LOCF; mITT
Baseline mean DLQI scores: Placebo, 11.4; Otezla, 13.6.
DLQI, Dermatology Life Quality Index.
*Actual clinical trial patient. Individual results may vary.
†Actual clinical trial patient from STYLE.1 Individual results may vary.
ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; PASI, Psoriasis Area and Severity Index.
STYLE: Efficacy and Safety of Apremilast in Patients with Moderate to Severe Plaque Psoriasis of the Scalp; ScPGA, scalp physician global assessment.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 3. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 4. Data on file, Amgen Inc. 5. Thaçi D, Kimball A, Foley P, et al. J Eur Acad Dermatol Venereol. 2017;31(3):498-506. 6. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 3. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 4. Data on file, Amgen Inc. 5. Thaçi D, Kimball A, Foley P, et al. J Eur Acad Dermatol Venereol. 2017;31(3):498-506. 6. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 3. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 4. Data on file, Amgen Inc. 5. Thaçi D, Kimball A, Foley P, et al. J Eur Acad Dermatol Venereol. 2017;31(3):498-506. 6. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 3. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 4. Data on file, Amgen Inc. 5. Thaçi D, Kimball A, Foley P, et al. J Eur Acad Dermatol Venereol. 2017;31(3):498-506. 6. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 3. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 4. Data on file, Amgen Inc. 5. Thaçi D, Kimball A, Foley P, et al. J Eur Acad Dermatol Venereol. 2017;31(3):498-506. 6. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 3. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 4. Data on file, Amgen Inc. 5. Thaçi D, Kimball A, Foley P, et al. J Eur Acad Dermatol Venereol. 2017;31(3):498-506. 6. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 3. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 4. Data on file, Amgen Inc. 5. Thaçi D, Kimball A, Foley P, et al. J Eur Acad Dermatol Venereol. 2017;31(3):498-506. 6. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Van Voorhees A, Gold LS, Lebwohl M, et al. Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study. J Am Acad Dermatol. 2020. doi:10.1016/j.jaad.2020.01.072 3. Data on file, Amgen Inc.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Van Voorhees A, Gold LS, Lebwohl M, et al. Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study. J Am Acad Dermatol. 2020. doi:10.1016/j.jaad.2020.01.072 3. Data on file, Amgen Inc.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Van Voorhees A, Gold LS, Lebwohl M, et al. Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study. J Am Acad Dermatol. 2020. doi:10.1016/j.jaad.2020.01.072 3. Data on file, Amgen Inc.
References: 1. Otezla [package insert]. Thousand Oaks, CA: Amgen Inc. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. 3. Paul C, Cather J, Gooderham M, et al. Br J Dermatol. 2015;173(6):1387-1399. 4. Data on file, Amgen Inc. 5. Thaçi D, Kimball A, Foley P, et al. J Eur Acad Dermatol Venereol. 2017;31(3):498-506. 6. Reich K, Gooderham M, Green L, et al. J Eur Acad Dermatol Venereol. 2017;31(3):507-517.
Reference: 1. Data on file, Amgen Inc.
Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.
Contraindications
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Please click here for Full Prescribing Information.
Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.
Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.
Contraindications
Warnings and Precautions
Adverse Reactions
Use in Specific Populations
Please click here for Full Prescribing Information.