Understanding the association between skin involvement and joint activity in patients with psoriatic arthritis: experience from the Corrona Registry.

Objective: To compare the characteristics of patients with psoriatic arthritis among patient groups stratified by degree of skin and joint involvement, and to evaluate the relationship between skin severity and joint activity. Methods: Body surface area (BSA) and Clinical Disease Activity Index (CDAI) at enrolment were analysed. Patient characteristics were stratified by skin severity and joint activity. Baseline patient characteristics, clinical and disease characteristics and patient-reported outcomes were compared. The strength of the relationship of skin severity and joint activity was evaluated using methods for categorical variables (χ Results: 1542 adult patients in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry enrolled between 21 May 2013 and 20 September 2016 were analysed. Most patients in the BSA \u3e3%/CDAI moderate/high subgroup had worse clinical and patient-reported outcomes. A significant (p Conclusion: Skin severity is modestly correlated with joint activity, and patients with higher skin severity are two times more likely to have increased joint involvement. Clinicians need to address both skin severity and joint activity in treatment decisions

L’ixékizumab permet d’obtenir une amélioration des symptômes du psoriasis génital rapide et plus importante que le placebo

Le psoriasis génital (PG) est une manifestation fréquente du psoriasis caractérisée par un prurit, des douleurs, et d’autres symptômes qui contribuent à l’apparition de troubles sexuels et à une baisse de la qualité de vie. Notre objectif était d’évaluer l’ixékizumab (IXE), un anticorps monoclonal de haute affinité ciblant de façon sélective l’interleukine-17A versus placebo (PBO), sur les symptômes du PG pendant 12 semaines dans un essai de phase 3b, randomisé, en double aveugle. Cent quarante patients atteints d’un PG modéré à sévère ont été randomisés (1 :1) pour recevoir un PBO ou 80mg d’IXE toutes les 2 semaines (dose initiale de 160mg). Les symptômes du PG ont été mesurés à l’aide de l’échelle des symptômes du psoriasis génital (Genital Psoriasis Symptom Scale [GPSS]) rapportés par le patient, composée d’échelles numériques (Numeric Rating Scale [NRS]) de 0 à 10 (0=aucun symptôme, 10=les pires symptômes imaginables) pour 8 symptômes fréquents (démangeaisons, douleurs, gêne, picotements, brûlures, rougeurs, desquamation, et fissures). Pour les items du score GPSS et les scores totaux, des comparaisons entre groupes de traitement ont été effectuées à l’aide de modèles mixtes pour l’analyse de mesures répétées. Pour les patients ayant un score de baseline NRS ≥ 3 pour les démangeaisons génitales, le pourcentage atteignant une amélioration ≥ 3 points par rapport à la baseline a été analysé au moyen d’une analyse de régression logistique et d’une imputation d’absence de réponse. IXE a permis d’obtenir une amélioration significative (p<0,001) du score total GPSS par rapport au PBO en 1 semaine et jusqu’à la semaine 12 ; la variation obtenue par la moyenne de la méthode des moindres carrés (gr)±erreur standard (ES) par rapport à la référence était de −31,57 (± 2,07) pour l’IXE et −2,82 (± 2,19) pour le PBO à la semaine 12. L’IXE était supérieur au PBO pour chacun des items du score GPSS à la semaine 1 (p<0,01) et à la semaine 12 (p<0,001). Les variations obtenues par la gr (± ES) par rapport à la référence pour chaque item du score GPSS à la semaine 12 (IXE et PBO, respectivement) étaient : démangeaisons : −4,02 (± 0,27) et −0,21 (± 0,29), douleurs : −3,84 (± 0,28) et −0,34 (± 0,29), gêne : −4,27 (± 0,28) et −0,42 (± 0,30), picotements : −3,74 (± 0,28) et −0,51 (± 0,30), brûlures : -−3,73 (± 0,27) et −0,53 (± 0,29), rougeurs : −4,45 (± 0,27) et −0,63 (± 0,29), desquamation : −3,80 (± 0,26) et −0,02 (± 0,27), et fissures : −3,74 (± 0,26) et −0,19 (± 0,28). Le taux de réponse de l’amélioration NRS ≥ 3 points des démangeaisons génitales était significativement plus élevé avec l’IXE dès la semaine 2 (p<0,001), et jusqu’à la semaine 12 (IXE : 59,7 %, PBO : 8,3 % ; p<0,001). Sur 12 semaines, les patients recevant de l’IXE ont eu des améliorations de la sévérité des symptômes de PG rapides et significativement plus importantes versus PBO

Ixekizumab Improved Patient-Reported Genital Psoriasis Symptoms and Impact of Symptoms on Sexual Activity vs Placebo in a Randomized, Double-Blind Study

Contains fulltext : 200214.pdf (Publisher’s version ) (Open Access)INTRODUCTION: Genital psoriasis (GenPs) is common and distressing for patients, but is often not discussed with physicians, and no previous clinical trials have assessed the effects of biologics specifically on GenPs and its associated symptoms. AIM: To report results for novel patient-reported outcomes (PROs) for the assessment of symptoms and the sexual impact of GenPs before and after treatment in the IXORA-Q study. METHODS: IXORA-Q (NCT02718898) was a phase III, randomized, double-blind, placebo-controlled study of ixekizumab (80 mg/2 weeks after 160-mg initial dose) vs placebo for GenPs. Men and women >/=18 years old with moderate-to-severe GenPs and body surface area (BSA) >/=1% were assessed through 12 weeks. MAIN OUTCOME MEASURE: GenPs symptoms were assessed using the 8-item Genital Psoriasis Symptoms Scale (GPSS), Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ), and Genital Psoriasis Sexual Impact Scale (GPSIS) (validation data presented in the supplemental materials), and the Dermatology Life Quality Index (DLQI) item 9. RESULTS: For patients receiving ixekizumab (N = 75) vs placebo (N = 74), statistically significant improvement in GenPs symptoms were seen from week 1 onward (GPSS total and individual items, all P /=1%. STRENGTH & LIMITATIONS: To our knowledge, this is the first phase III, randomized, placebo-controlled, double-blinded clinical trial to evaluate the effect of any treatment on the symptoms and sexual impact related to GenPs. The study did not include an active comparator owing to the lack of any well-established treatment for moderate-to-severe GenPs, and the period assessed herein was of relatively short duration. CONCLUSION: These validated PRO measures may aid in future clinical studies of GenPs and in facilitating discussions of GenPs symptoms and their impact between patients and clinicians. Yosipovitch G, Foley P, Ryan C. Ixekizumab improved patient-reported genital psoriasis symptoms and impact of symptoms on sexual activity vs placebo in a randomized, double-blind study. J Sex Med 2018;15:1645-1652

Disease response and patient-reported outcomes among initiators of ixekizumab

Objectives There is limited real-world evidence on using ixekizumab in psoriasis patients. Therefore, we characterized patients with psoriasis initiating ixekizumab and report 6-month changes in disease and patient-reported outcomes. Methods Adult patients with psoriasis who initiated ixekizumab and completed a 6-month follow-up visit were enrolled from the Corrona Psoriasis Registry. Disease characteristics and outcomes were assessed at ixekizumab initiation. Outcomes included the mean 6-month change in Psoriasis Area and Severity Index (PASI), body surface area (BSA), Investigator Global Assessment (IGA), and IGA*BSA. Results From baseline to follow-up in all patients (n = 136), means decreased for IGA*BSA (−45.5) and BSA (−12.4), and a higher % achieved an absolute PASI ≤ 5 (84.6%), BSA 0–3 (72.1%), and IGA 0/1 (50.7%). Within stratified groups, means decreased for PASI <12 for IGA*BSA (−21.1) and BSA (−6.3); PASI≥12 for IGA*BSA (−94.8) and BSA (−24.6); weight <100 kg for IGA*BSA (−45.1) and BSA (−12.4); weight ≥100 kg for IGA*BSA (−46.2) and BSA (−12.3); concomitant PsA for IGA*BSA (−56.0) and BSA (−15.3); and in no concomitant PsA for IGA*BSA (−36.9) and BSA (−10.0). Conclusions We provide real-world evidence on the benefits of ixekizumab for treating psoriasis, regardless of baseline disease severity, weight, or concomitant PsA