46 5 th World Psoriasis & Psoriatic Arthritis Conference 2018
P112 GASTROINTESTINAL SYMPTOMS ARE COMMON IN
U. S. PATIENTS WITH MODERATE-SEVERE PSORIASIS Steven Feldman 1, Steve Fakharzadeh 2, Jill Abell 2, Timothy Hoops 2, Bhaskar Srivastava 2, Erik Muser 2, Danielle Dungee 2, Sean Quinn 2, Megan Leone Perkins 3, Michael Kappelman 4
1
Wake Forest School of Medicine, Winston-Salem, NC, 2 Janssen Scientific Affairs, LLC, Horsham PA, 3 HealthiVibe, LLC, Arlington, VA, 4 University of North Carolina, Chapel Hill, NC, USA
Background / Objective: Patients with moderate-to-severe plaque psoriasis( PsO) are at increased risk of developing inflammatory bowel disease( IBD). A survey was conducted to evaluate the prevalence of gastrointestinal symptoms in PsO patients. Methods: An electronic survey was available to U. S. PsO patients with data collected from Jan-Feb. 2017. Patients with moderateto-severe plaque PsO and healthy controls( HC), with common co-morbidities allowed in both groups qualified for inclusion in the survey. Psoriasis patients were further categorized as those without recent exposure to biologic therapy( PsO-) vs those with recent( within 4 months) biologic exposure( PsO +). GI symptoms and signs, including frequency and severity, were compared across groups. CalproQuest( CPQ) scores, which have recently been proposed as a tool to identify patients with elevated fecal calprotectin levels and increased risk for IBD, were also calculated. Patients with inflammatory bowel disease( IBD), inflammatory bowel syndrome( IBS), or other gastrointestinal( GI) diagnoses with symptoms that overlap with IBD were excluded. Results: Overall, 915 patients with self-reported moderate-severe PsO and 1,411 healthy controls participated. Demographics were generally comparable between groups. GI symptoms and signs were significantly more prevalent in the PsO- and PsO + groups vs the HC group, respectively: pain- 20.6 % and 36.9 % vs 10.5 %; fullness / bloating- 37.2 % and 48.4 % vs 25.3 %; and diarrhea( 16.3 % and 29.3 % vs 12.2 %( all p-values = 0.002 except diarrhea for PsO- vs HC, p = 0.023). Mucous and blood in the stool followed a similar pattern. A significantly greater percentage of PsO- and PsO + patients had positive CPQ scores vs HCs, with the greatest percentage of positive CPQ scores in the PsO + group. Conclusion: GI symptoms and signs are common in patients with moderate-to-severe PsO, more so than in healthy controls. This suggests that physicians caring for patients with PsO may consider assessing for GI symptoms and signs, and monitoring for their progression with treatment of PsO to identify patients potentially at risk for developing IBD.
P113 SECUKINUMAB’ S LONG-TERM SAFETY REMAINS
FAVORABLE UP TO 5 YEARS OF TREATMENT Christopher Griffiths 1, A. Blauvelt 2, K. Reich 3, C. Leonardi 4, N. Mehta 5, T. Tsai 6, R. You 7, P. Papanastasiou 8, M. Milutinovic 8, P. van de Kerkhof 9
1
Dermatology Centre, Salford Royal Hospital, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK, 2 Oregon Medical Research Center, Portland, Oregon, USA, 3 Dermatologikum Berlin and Georg-August-University, Göttingen, Germany, 4 Saint Louis University Health Sciences Center, St. Louis, Missouri, 5 National Heart, Lung, and Blood Institute, Bethesda, Maryland, USA, 6 National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan, 7 China Novartis Institutes for BioMedical Research, Shanghai, China,
8
Novartis Pharma AG, Basel, Switzerland, 9 Department of Dermatology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
Introduction and Objectives: Psoriasis is a condition typically requiring long-term treatment, thus longitudinal data establishing the safety of approved therapies are required. We report exposure adjusted incidence rates( IRs per 100 patient years) for treatmentemergent adverse events( AEs) per year of treatment from a pooled analysis of all secukinumab psoriasis trials to date( 19 studies,
4,674 patients, 10,061 patient-years exposure; secukinumab exposure up to 5 years). Methods: AE IRs were examined per year for subjects receiving secukinumab, and for 52 weeks only for those receiving etanercept( ETN), ustekinumab( UST), or placebo( PBO). Results: Duration of exposure through 52 weeks of secukinumab treatment 300 mg, ETN 50 mg, UST 45 / 90 mg, and PBO was 1467.4, 296.9, 318.1, and 301 patient-years, respectively. Exposure duration through 2, 3, 4, and 5 years of secukinumab 300 mg treatment was 859.6, 423, 377.5, and 90 patient-years. Over 52 weeks for secukinumab, ETN, UST, and PBO, respectively, exposure adjusted IRs were overall comparable across treatments: total AEs( 275.6, 245.7, 252.2, 355.8); nasopharyngitis( 28.4, 35.9, 31.2, 35.9); headache( 12.6, 15, 14.6, 23.7); upper respiratory infections [ URI ]( 9.1, 5.9, 9.9, 8.8); opportunistic infections( 0.2, 0.3, 0.3, 0.3); Candida infections( 4.7, 1.4, 1.6, 1.7); neutropenia( 0.5, 1.4, 0, 0); major adverse cardiovascular events [ MACE ]( 0.5, 0.3, 0.3, 1.3); Crohn’ s disease( 0.1, 0, 0, 0); ulcerative colitis( 0.1, 0.3, 0, 0); and malignant or unspecified tumors [ excluding nonmelanoma skin cancer [ NMSC ]]( 0.4, 0.3, 0.3, 0.3). Secukinumab 300 mg pooled safety remained favorable over time with no increases in AEs( exposure adjusted IRs for up to Year 1 to Year 5, respectively): total AEs( 275.6, 168.1, 160.2, 111.9, 13.9); nasopharyngitis( 28.4, 21.2, 24.1, 11.8, 3.4); headache( 12.6, 5.4, 4.3, 4.9, 0); URI( 9.1, 7.3, 6.1, 5.5, 0); opportunistic infections( 0.2, 0.1, 0, 0, 0); Candida infections( 4.7, 3.6, 1.9, 1.3, 1.1); neutropenia( 0.5, 0.1, 0, 0, 0); MACE( 0.5, 0.1, 0.5, 0, 0); Crohn’ s disease( 0.1, 0, 0, 0, 0); ulcerative colitis( 0.1, 0.4, 0.2, 0.3, 0); and malignant or unspecified tumors [ excluding NMSC ]( 0.4, 0.4, 0.2, 0, 0). Conclusions: This comprehensive pooled analysis supports the favorable long-term safety profile of secukinumab in patients with psoriasis; no new safety signals were identified for up to 5 years of treatment and secukinumab’ s safety profile was consistent with that established in a large phase 3 program. Findings previously published at the AAD Annual Meeting, February 16 – 20, 2018, San-Diego, California.
P114 IMPACT OF IMPROVEMENT IN SKIN AND JOINT ON QUALITY OF LIFE IN ACTIVE PSORIATIC ARTHRITIS
PATIENTS Arthur Kavanaugh 1, Alice Gottlieb 2, Akimichi Morita 3, Joseph F Merola 4, Julie Birt 5, Chen-Yen Lin 5, Catherine L Shuler 5, Diamant
Thaçi 6 1
University of California, San Diego, CA, 2 Department of Dermatology, New York Medical College at Metropolitan Hospital, New York, NY, USA,
3
Nagoya City University Medical School, Nagoya, Japan, 4 Harvard Medical School, Brigham and Women’ s Hospital, Boston, MA, 5 Eli Lilly and Company, Indianapolis, IN, USA, 6 University Hospital Schleswig Holstein Campus Luebeck, Ratzeburger Allee, Germany
Introduction: Psoriatic arthritis( PsA) is a chronic immunemediated inflammatory disease affecting peripheral and axial joints. For patients with active psoriasis, the added burden of skin disease can further reduce health-related quality of life( HRQoL) of patients with joint disease. Objective: To determine the contribution of joint and skin improvements in HRQoL of patients with active PsA during Phase 3 clinical trials investigating ixekizumab( IXE) treatment. Methods: The double-blind Phase 3 trials( SPIRIT) investigated the treatment of IXE, a high-affinity monoclonal antibody selectively targeting interleukin-17A, for patients with active PsA. The integrated database of 2 SPIRIT trials consisted of biologic disease-modifying antirheumatic drug( DMARD)-naïve patients( SPIRIT-P1, NCT01695239) or inadequate responders to tumor necrosis factor( TNF)-inhibitors( SPIRIT-P2, NCT02349295). Patients were randomized to 80mg IXE every 4 weeks( Q4W, www. medicaljournals. se / acta