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Patient-reported outcomes with etanercept therapy in patients with plaque psoriasis who lost response to adalimumab
4411 Patient-reported outcomes with etanercept therapy in patients with plaque psoriasis who lost response to adalimumab Kim A. Papp, MD, Probity Medical Research; Stephen Tyring, MD, University of Texas Health Science Center and Center for Clinical Studies; Bradley S. Stolshek, PharmD, Amgen Inc.; Kara Creamer Rice, MS, Amgen Inc.; David H. Collier, MD, Amgen Inc.; Greg Kricorian, MD, Amgen Inc.; Jan Iles, MD, Amgen Inc.; Arunan Kaliyaperumal, PhD, Amgen Inc.; Jerry Bagel, MD, Psoriasis Treatment Center of Central New Jersey Objective: To evaluate patient-reported outcomes (PROs) with etanercept (ETN) therapy in patients with moderate to severe plaque psoriasis who lost satisfactory response to adalimumab (ADA). Methods: This phase 4, open-label, single-arm estimation study enrolled adults with moderate to severe plaque psoriasis who had secondary failure after adequate response to ADA. Previous satisfactory response to ADA was defined as static physician global assessment (sPGA) score 0/1 (clear/almost clear). If sPGA was unavailable, a 75% improvement in Psoriasis Area and Severity Index (PASI 75) or 75% improvement in psoriasis-affected body surface area (BSA) was also acceptable. Secondary failure of ADA was defined as sPGA $3 (moderate or worse) or loss of PASI 50 response within 6 months before initiating ETN therapy. At baseline, patients had sPGA $3, PASI score $10, and psoriasis-affected BSA $10%. Patients received ETN 50 mg twice weekly for 12 weeks followed by 50 mg once weekly for 12 weeks. PROs included patient assessments of itch, pain, and flaking (scale ¼ 0/none to 10/worst), treatment satisfaction (very dissatisfied to very satisfied), Dermatology Life Quality Index (DLQI; scale ¼ 0/no effect to 30/extremely large effect), and Work Productivity and Activity Impairment (WPAI) questionnaire (% time or % degree of impairment). Only employed patients completed WPAI work productivity outcomes. Data with 95% confidence intervals (CI) are reported as observed with no imputation for missing data. Results: Sixty-four patients (63% male, mean age 46.0 years) enrolled; 56 patients completed week 24. Mean (95% CI) scores at baseline and week 12, respectively, were: 6.5 (5.9e7.2) and 2.5 (1.9e3.1) for itch; 5.0 (4.2e5.8) and 1.3 (0.9e1.8) for pain; and 7.0 (6.4e7.5) and 2.7 (2.1e3.3) for flaking. At baseline, 4 patients (6.4%) were satisfied/very satisfied with treatment compared to 38 patients (63.3%) at week 12. Mean DLQI total score (95% CI) was 12.7 (11.0e14.3) at baseline and 4.8 (3.5e6.1) at week 12. At baseline and week 12, respectively, presenteeism was 24.8% (17.0%e32.5%) and 8.3% (3.9%e12.6%); absenteeism was 2.1% (0.1%e4.0%) and 0.1% (-0.1%e0.3%); work productivity loss was 23.3% (15.5%e31.1%) and 7.5% (3.5%e11.4%); and activity impairment was 36.0% (28.0%e44.0%) and 9.8% (5.7% e14.0%). Conclusion: PROs improved from baseline and were maintained through week 24 in patients with moderate to severe plaque psoriasis treated with ETN following secondary failure of ADA. Commercial support: This study was sponsored by Immunex, a wholly owned subsidiary of Amgen Inc. and by Wyeth, which was acquired by Pfizer in October 2009.
4766 Patient-reported symptoms and signs in patients with moderatesevere plaque psoriasis treated with guselkumab or adalimumab: Results from VOYAGE 1, a phase III clinical trial Andrew Blauvelt, MD, Oregon Medical Research Center; Kim Papp, MD, K Papp Clinical Research and Probity Research, Inc.; Christopher E.M. Griffiths, MD, Dermatology Centre, Salford Royal Hospital, U of Manchester, Manchester Academic Health Science Cent; Chenglong Han, MD, Janssen Research & Development, LLC; Bruce Randazzo, MD, Janssen Research & Development, LLC; Yasmine Wasfi, MD, Janssen Research & Development, LLC; Shu Li, PhD, Janssen Research & Development, LLC; Alexa B. Kimball, MD, Depart of Dermatology, Harvard Medical School Background: Guselkumab, a selective IL-23 blocker, is highly efficacious for treating psoriasis (PsO). Patient-reported symptoms & signs were evaluated in PsO patients treated with GUS or adalimumab (ADA). Methods: VOYAGE 1 is a phase 3, randomized, double-blind, placebo- & active comparator-controlled trial. Eligible patients (age$18 years) had plaque PsO for $6 months, baseline IGA $3, PASI $12, and BSA involvement $10%, & were candidates for systemic therapy or phototherapy. At baseline, 837 patients were randomized to either GUS 100mg at wks0/4/12, & q8wk through wk44 (n ¼ 329), placebo (PBO) at wks 0/4/12 followed by GUS 100mg at wks16/20, & q8wk through wk44 (n ¼ 174); or ADA 80mg at wk0, 40mg at wk1, & 40mg q2wk through wk47 (n ¼ 334). The PsO Symptom & Sign Diary (PSSD) was used to assess severity of symptoms (itch, burning, stinging, skin tightness, & pain) & patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) with 0-10 numerical rating scales. The average score of five symptoms & the average score of six signs were used to calculate the symptom summary score & sign summary score (ranging 0100); higher scores indicated greater severity. Numeric data were analyzed with ANOVA model & categorical responses were analyzed using the CochraneManteleHaenszel test. Results: At baseline, mean (SD) PSSD symptom scores were 54.4( 6 24.63) & 53.9 ( 6 25.79) & mean sign scores were 56.9 ( 6 21.30) & 58.5( 6 21.73) for GUS & ADA,
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respectively. Compared to the ADA group, numerically greater improvements in both the mean symptom & sign scores were observed for the GUS group as early as wk4. At wk24, when compared to the ADA group, the GUS group had statistically greater improvements in the symptom (40.0 vs 36.0, P\.001) & sign (47.2 vs 40.1, P \.001) scores. Greater proportions of GUS patients achieved a clinically meaningful ($40 point) improvement in symptom (79.9% vs 63.8%, P \.001) & sign (78.7% vs 65.2%, P ¼.002) scores, and symptom-free score of 0 (36.3% vs 21.6%, P \.001) & sign-free score of 0 (29.4% vs 14.6%, P \.001). Differences between the GUS & ADA groups were maintained through wk48. Similarly, significantly greater improvements in individual PSSD symptom & sign scores were observed for GUS patients vs ADA patients at wk24 & 48. Conclusion: Treatment with GUS resulted in significantly greater improvements in patient-reported signs & symptoms of PsO when compared with ADA-treated patients. Commercial support: 100% sponsored by Janssen Research & Development, LLC.
4826 Patients at risk for psoriatic arthritis among those with psoriasis: Analysis from the Corrona Psoriasis Registry Philip Mease, MD, Swedish Medical Center and University of Washington; Jacqueline Palmer, PharmD, Novartis Pharmaceuticals Corporation; Bruce Strober, MD, University of Connecticut Health Center; Mark Lebwohl, MD, Icahn School of Medicine at Mount Sinai; Chitra Karki, MPH, Corrona, LLC; George Reed, PhD, Corrona, LLC; University of Massachusetts Medical School; Jeffrey Greenberg, MD, Corrona, LLC; New York University School of Medicine; Philip Helliwell, MD, University of Leeds Objective: Despite increasing awareness of the disease, undiagnosed psoriatic arthritis (PsA) remains high in patients with psoriasis (PsO). The Psoriasis Epidemiology Screening Tool (PEST) was developed to help identify PsA at an early stage. This study assessed the prevalence of PsA among patients with PsO and characterized patients with possibly undiagnosed PsA based on PEST scores. Methods: This study included all patients enrolled in the Corrona PsO registry with non-missing data on all 5 PEST questions. Demographics, disease characteristics, patient-reported outcomes and medication use were analyzed at the time of enrollment and compared between patients who may have undiagnosed PsA (PEST score $ 3) vs those with a PEST score\3 using t tests for continuous variables and chi-squared tests for categorical variables. Results: As of June 2016, 99.1% (1516/1529) of patients with PsO in the Corrona PsO registry had non-missing data on all 5 PEST questions; of these, 612 patients (40.4%) had dermatologist-reported PsA at enrollment. Among the remaining 904 patients without dermatologist-reported PsA, 112 patients (12.4%) had a PEST score $ 3 and were considered to possibly have undiagnosed PsA. These patients were significantly older (52.9 vs 49.2 years), more likely to be female (55.4% vs 42.8%), had a higher BMI (32.2 vs 29.5 kg/m2), were less likely to have full/part-time work (53.2% vs 70.9%) and were more likely to have certain comorbidities (eg, hypertension, hyperlipidemia and depression/anxiety) at enrollment vs patients with a PEST score \3 (all P\.05). Patients with a PEST score $ 3 also had significantly longer duration of PsO (17.3 vs 14.6 years; P \.001) and were more likely to have nail PsO (21.4% vs 10.9%; P ¼.001). Both groups were similar in terms of PsO disease severity (BSA, IGA and PASI); however, patients with PEST score $ 3 had significantly worse EQ5D health state (67.0 vs 76.4), DLQI score (8.1 vs 6.2), pain (28.3 vs 21.3) and fatigue (41.7 vs 25.0; all P \.05). Conclusion: A validated screening tool (PEST) identified patients in the Corrona PsO registry who may have undiagnosed PsA; these patients exhibited similar severity of PsO as those with a PEST score \ 3, but had higher BMI and worse quality of life, pain and fatigue. These findings highlight the value of screening for PsA among patients with PsO to improve PsA diagnosis and patient outcomes. Commercial support: This study is sponsored by Corrona, LLC. The Corrona Psoriasis Registry is funded by Novartis Pharmaceutical Corporation and Eli Lilly and Company. Corrona, LLC, has been supported through contracted subscriptions in the last two years by AbbVie and Amgen.
J AM ACAD DERMATOL
AB191
4766 Patient-reported symptoms and signs in patients with moderatesevere plaque psoriasis treated with guselkumab or adalimumab: Results from VOYAGE 1, a phase III clinical trial Andrew Blauvelt, MD, Oregon Medical Research Center; Kim Papp, MD, K Papp Clinical Research and Probity Research, Inc.; Christopher E.M. Griffiths, MD, Dermatology Centre, Salford Royal Hospital, U of Manchester, Manchester Academic Health Science Cent; Chenglong Han, MD, Janssen Research & Development, LLC; Bruce Randazzo, MD, Janssen Research & Development, LLC; Yasmine Wasfi, MD, Janssen Research & Development, LLC; Shu Li, PhD, Janssen Research & Development, LLC; Alexa B. Kimball, MD, Depart of Dermatology, Harvard Medical School Background: Guselkumab, a selective IL-23 blocker, is highly efficacious for treating psoriasis (PsO). Patient-reported symptoms & signs were evaluated in PsO patients treated with GUS or adalimumab (ADA). Methods: VOYAGE 1 is a phase 3, randomized, double-blind, placebo- & active comparator-controlled trial. Eligible patients (age$18 years) had plaque PsO for $6 months, baseline IGA $3, PASI $12, and BSA involvement $10%, & were candidates for systemic therapy or phototherapy. At baseline, 837 patients were randomized to either GUS 100mg at wks0/4/12, & q8wk through wk44 (n ¼ 329), placebo (PBO) at wks 0/4/12 followed by GUS 100mg at wks16/20, & q8wk through wk44 (n ¼ 174); or ADA 80mg at wk0, 40mg at wk1, & 40mg q2wk through wk47 (n ¼ 334). The PsO Symptom & Sign Diary (PSSD) was used to assess severity of symptoms (itch, burning, stinging, skin tightness, & pain) & patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding) with 0-10 numerical rating scales. The average score of five symptoms & the average score of six signs were used to calculate the symptom summary score & sign summary score (ranging 0100); higher scores indicated greater severity. Numeric data were analyzed with ANOVA model & categorical responses were analyzed using the CochraneManteleHaenszel test. Results: At baseline, mean (SD) PSSD symptom scores were 54.4( 6 24.63) & 53.9 ( 6 25.79) & mean sign scores were 56.9 ( 6 21.30) & 58.5( 6 21.73) for GUS & ADA,
JUNE 2017
respectively. Compared to the ADA group, numerically greater improvements in both the mean symptom & sign scores were observed for the GUS group as early as wk4. At wk24, when compared to the ADA group, the GUS group had statistically greater improvements in the symptom (40.0 vs 36.0, P\.001) & sign (47.2 vs 40.1, P \.001) scores. Greater proportions of GUS patients achieved a clinically meaningful ($40 point) improvement in symptom (79.9% vs 63.8%, P \.001) & sign (78.7% vs 65.2%, P ¼.002) scores, and symptom-free score of 0 (36.3% vs 21.6%, P \.001) & sign-free score of 0 (29.4% vs 14.6%, P \.001). Differences between the GUS & ADA groups were maintained through wk48. Similarly, significantly greater improvements in individual PSSD symptom & sign scores were observed for GUS patients vs ADA patients at wk24 & 48. Conclusion: Treatment with GUS resulted in significantly greater improvements in patient-reported signs & symptoms of PsO when compared with ADA-treated patients. Commercial support: 100% sponsored by Janssen Research & Development, LLC.
4826 Patients at risk for psoriatic arthritis among those with psoriasis: Analysis from the Corrona Psoriasis Registry Philip Mease, MD, Swedish Medical Center and University of Washington; Jacqueline Palmer, PharmD, Novartis Pharmaceuticals Corporation; Bruce Strober, MD, University of Connecticut Health Center; Mark Lebwohl, MD, Icahn School of Medicine at Mount Sinai; Chitra Karki, MPH, Corrona, LLC; George Reed, PhD, Corrona, LLC; University of Massachusetts Medical School; Jeffrey Greenberg, MD, Corrona, LLC; New York University School of Medicine; Philip Helliwell, MD, University of Leeds Objective: Despite increasing awareness of the disease, undiagnosed psoriatic arthritis (PsA) remains high in patients with psoriasis (PsO). The Psoriasis Epidemiology Screening Tool (PEST) was developed to help identify PsA at an early stage. This study assessed the prevalence of PsA among patients with PsO and characterized patients with possibly undiagnosed PsA based on PEST scores. Methods: This study included all patients enrolled in the Corrona PsO registry with non-missing data on all 5 PEST questions. Demographics, disease characteristics, patient-reported outcomes and medication use were analyzed at the time of enrollment and compared between patients who may have undiagnosed PsA (PEST score $ 3) vs those with a PEST score\3 using t tests for continuous variables and chi-squared tests for categorical variables. Results: As of June 2016, 99.1% (1516/1529) of patients with PsO in the Corrona PsO registry had non-missing data on all 5 PEST questions; of these, 612 patients (40.4%) had dermatologist-reported PsA at enrollment. Among the remaining 904 patients without dermatologist-reported PsA, 112 patients (12.4%) had a PEST score $ 3 and were considered to possibly have undiagnosed PsA. These patients were significantly older (52.9 vs 49.2 years), more likely to be female (55.4% vs 42.8%), had a higher BMI (32.2 vs 29.5 kg/m2), were less likely to have full/part-time work (53.2% vs 70.9%) and were more likely to have certain comorbidities (eg, hypertension, hyperlipidemia and depression/anxiety) at enrollment vs patients with a PEST score \3 (all P\.05). Patients with a PEST score $ 3 also had significantly longer duration of PsO (17.3 vs 14.6 years; P \.001) and were more likely to have nail PsO (21.4% vs 10.9%; P ¼.001). Both groups were similar in terms of PsO disease severity (BSA, IGA and PASI); however, patients with PEST score $ 3 had significantly worse EQ5D health state (67.0 vs 76.4), DLQI score (8.1 vs 6.2), pain (28.3 vs 21.3) and fatigue (41.7 vs 25.0; all P \.05). Conclusion: A validated screening tool (PEST) identified patients in the Corrona PsO registry who may have undiagnosed PsA; these patients exhibited similar severity of PsO as those with a PEST score \ 3, but had higher BMI and worse quality of life, pain and fatigue. These findings highlight the value of screening for PsA among patients with PsO to improve PsA diagnosis and patient outcomes. Commercial support: This study is sponsored by Corrona, LLC. The Corrona Psoriasis Registry is funded by Novartis Pharmaceutical Corporation and Eli Lilly and Company. Corrona, LLC, has been supported through contracted subscriptions in the last two years by AbbVie and Amgen.
J AM ACAD DERMATOL
AB191