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5 th World Psoriasis & Psoriatic Arthritis Conference 2018
cy and safety in patients with moderate-to-severe plaque psoriasis in two phase 3, double-blinded, randomized controlled trials( re- SURFACE 1: NCT01722331; reSURFACE 2: NCT01729754) 1. Objective: The analysis examined the association between qualityof-life improvements and the degree of skin clearance in patients enrolled in the two phase 3 trials and treated with tildrakizumab 100 mg or 200 mg at weeks 0, 4, then every 12 weeks. Methods: Both trials used a three-part design: Part 1( weeks 0 – 12) was placebo-controlled; Part 2( weeks 12 – 28) re-randomized placebo patients to receive tildrakizumab 100 or 200 mg; Part 3( weeks 28 – 64, reSURFACE 1; weeks 28 – 52, reSURFACE 2) rerandomized patients from the tildrakizumab arms with Psoriasis Area and Severity Index( PASI) response ≥50 at week 28 to receive the same, a higher, or a lower dose of tildrakizumab, or placebo( randomized withdrawal in reSURFACE 1). The Dermatology Life Quality Index( DLQI) questionnaire was administered at weeks 0, 12, 28, 40, and 52. Tildrakizumab-treated patients were pooled from the two trials and classified into 5 mutually exclusive groups based on their week-28 PASI response: PASI < 50, PASI 50 – 74, PASI 75 – 89, PASI 90 – 99, and PASI 100. Baseline characteristics, the proportion of patients with DLQI 0 / 1, and mean DLQI changes from baseline were examined for each PASI response group. Results: Overall, 575 patients on tildrakizumab 100 mg( male: 69.6 %; mean baseline age: 45.6 years) and 581 on tildrakizumab 200 mg( male: 73.0 %; mean baseline age: 45.9 years) were included. At week 28, 8.3 %, 22.0 %, 40.9 %, 66.3 %, and 86.5 %( 8.7 %, 35.2 %, 43.9 %, 70.4 %, and 85.9 %) of patients with PASI < 50, 50 – 74, 75 – 89, 90 – 99, and 100 achieved DLQI 0 / 1 for those on 100 mg( 200 mg), respectively. Patients with higher week-28 PASI response also had greater mean DLQI reductions from baseline at week 28( 100 mg: 5.7-13.4; 200 mg: 5.4 – 12.9). Similar patterns were observed among patients continuously treated with tildrakizumab 100 mg or 200 mg from baseline to week 52, with better PASI-response patients having greater proportions achieving DLQI 0 / 1 and greater DLQI reductions sustained from week 28 through week 52. Conclusion: Tildrakizumab-treated patients with higher levels of PASI response also demonstrated better quality-of-life improvements. Achieving PASI 100 was not necessarily associated with achieving DLQI 0 / 1, therefore both efficacy and quality-of-life improvements need to be evaluated separately to provide a complete picture of treatment success. Reference: 1. Reich K, Papp KA, Blauvelt A, et al. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis( reSURFACE 1 and reSUR- FACE 2): results from two randomised controlled, phase 3 trials. Lancet. 2017; 390( 10091): 276-288. This abstract has been accepted by 2018 EADV Spring Symposium.
P071 STATISTIC REVIEW OF PSORIASIS SYSTEMATIC THERAPIES IN NORTH GREECE Konstantinos Efthimiadis, Florentina-Silvia Delli State Clinical for Skin and Venereal Diseases Thessaloniki, Greece
Introduction: Psoriasis is a chronic disease that can have a significant effect on quality of life. Therefore, management of psoriasis involves both psychosocial and physical aspects of this disease, lately generally admitted as systemic. Numerous topical and systemic therapies are available for the treatment of the cutaneous manifestations of psoriasis. In our daily clinical practice, treatment modalities are chosen on the basis of disease severity estimated with PASI and DLQI, relevant comorbidities, and patient preference. Objective: To assess the frequencies of each systemic drug, classical or biological, used for the treatment of mild, moderate to severe psoriasis in our hospital care unit from January 2016 since December 2016.
Methods: Moderate to severe psoriasis was defined by PASI > 10 and / or DLQI > 10 and / or any PASI in a patient with psoriatic arthritis. Results: Most of our patients with mild to moderate psoriasis are using topical and classical therapies. A significant number of patients with severe psoriasis are using biological therapies and about a half of them were already used a classical or other biologic drug. Conclusion: Despite the fact that new biological drugs are available for psoriasis treatment, it seems that the patients with mild psoriasis are still treating with topical products. At least as far as it concerns our Mediterranean country, it seems that our patients difficult accept the biological therapies as first choice line treatment.
P073 PHARMAKOVIGILANCE OF SYSTEMIC ANTIPSORITIC
DRUGS: AN UPDATE FROM ROUTINE CARE Christina Sorbe 1, Laura Kühl 1, Stephan Jeff Rustenbach 1, Ralph von Kiedrowski 2, Marc Alexander Radtke 1, Matthias Augustin 1
1
University Medical Center Hamburg-Eppendorf, 2 Dermatological office, Selters
Introduction & Objectives: The spectrum of antipsoriatic systemic therapies is constantly changing. The short-term efficacy and safety of the various therapies are demonstrated in controlled clinical studies. The German Psoriasis Registry PsoBest aims to gain long-term evidence of safety and effectiveness in routine care. Updated interim data of long-term safety of biological and non-biological treatment of psoriasis is presented. Materials & Methods: The non-interventional German Psoriasis Registry PsoBest observes adult patients with moderate to severe psoriasis and / or psoriatic arthritis. Patients are registered at naïve systemic treatment start and are observed for 10 years in routine care. The registry aims to gain long-term evidence of safety and effectiveness of systemic antipsoriatic drugs. Data is collected in dermatological practices and walk-in clinics. Presented are standardised patient rates per 100 patient years( py) of exposure classified by system organ classes of MedDRA ®( SOC, Medical Dictionary for Regulatory Activities). Results: Until June 2017, 5,825 patients were registered and sufficient for analyses. They were predominantly male( 58.8 %), had a mean age of 47.7 years( SD 14.5) and 30.0 % of patients suffered psoriatic arthritis. 4,729 patient years( py) were observed on biologic treatments and 6,583 py on other systemic treatments. For all cause death, malignancies and other serious adverse events( SAE), there were no significant differences between the treatment cohorts. Highest SAE rates were observed in the SOCs Surgical and medical procedures( 3.5 and 2.6 patients / 100 py on biologics and non-biologics, respectively), General disorders and administration site conditions( 2.0 and 1.8 patients / 100 py), Infections and infestations( 1.6 and 1.1 patients / 100 py) and Neoplasms( 1.4 and 1.3 patients / 100 py). Events from other SOCs were observed for less than 1 patient / 100 py. Non-serious adverse events( AE) within the SOCs Skin and subcutaneous tissue disorders, Renal and urinary disorders, Blood and lymphatic system disorders, Gastrointestinal disorders, Nervous system disorders, Vascular disorders as well as Investigations were less frequent in biologic treatment compared to non-biologics( 2.2 vs. 5.3, 0.3 vs. 0.7, 0.4 vs. 2.3, 2.4 vs. 11.3, 1.3 vs. 2.7, 1.2 vs. 2.1 and 2.0 vs. 3.4 patients / 100 py, respectively, p ≤ 0.05). Non-serious infections were observed more often in biologics( 7.0 vs. 4.8 0 patients / 100 py, p ≤ 0.05). For the lately authorized treatments secukinumab and apremilast 253 and 111 py were observed, for biosimilar treatment 5 py. They showed no deviations from the previously observed safety profile of other systemic therapies. Conclusions: In the general, no increased risk of biological or non-biological treatments was observed. The specific differences in non-serious events will be evaluated in more detail in future www. medicaljournals. se / acta