Background The Psoriatic Arthritis Magnetic Resonance Imaging Scoring System (PsAMRIS) and MRI Whole-Body Scoring System for Inflammation in Peripheral Joints and Entheses in Inflammatory Arthritis (MRI-WIPE) have not been used together to assess treatment of psoriatic arthritis in a clinical trial. We aimed to assess the effect of apremilast treatment on inflammation, with outcomes measured by PsAMRIS and MRI-WIPE. Methods MOSAIC was a phase 4, multicentre, single-arm, open-label study conducted at 29 sites across ten countries (Belgium, Canada, Denmark, Germany, Italy, Russia, Spain, Switzerland, the UK, and the USA). Adults aged 18 years older with a documented diagnosis of psoriatic arthritis for a duration of 3 months to 5 years self-enrolled and were included if they met the classification criteria for active psoriatic arthritis at screening. Patients were required to have least three swollen and three tender joints with hand involvement and at least one active enthesitis site according the Spondyloarthritis Research Consortium of Canada enthesitis index or the Leeds enthesitis index. Patients were excluded if they had previous treatment with a biological disease-modifying antirheumatic drug or previous treatment with more than two conventional synthetic disease-modifying antirheumatic drugs. After a 5-day titration period, patients received apremilast 30 mg orally twice per day. Concomitant stable methotrexate up to 25 mg per week was permitted. The primary endpoint was change from baseline to week 24 in a composite inflammation score of bone marrow oedema, synovitis, and tenosynovitis in the hand as assessed by PsAMRIS. The full analysis set and safety population included all enrolled patients who received at least one dose of apremilast. This completed study is registered with ClinicalTrials.gov (NCT03783026). Findings Between Feb 6, 2019, and May 11, 2022, 123 patients were enrolled in the MOSAIC study. Ofthese 123 patients, 122 (99%) were treated with apremilast and included in the full analysis set and safety population. 67 (55%) of 122 patients were female, 55 (45%) were male, and 116 (95%) were White. 80 (66%) of 122 patients completed 48 weeks treatment. The least squares mean change from baseline to week 24 in the composite inflammation score of bone marrow oedema, synovitis, and tenosynovitis as assessed by PsAMRIS was -232 (95% CI -473 to 009). (78%) of 122 patients had at least one treatment-emergent adverse event. Six (5%) patients had a severe treatment- emergent adverse event and six (5%) patients had a serious treatment-emergent adverse event. No serious treatment- emergent adverse events were considered to be related to apremilast. Interpretation Apremilast improved inflammation in joints and entheses on assessment of MRI measures in the hand and the whole body. Our findings encourage the use of MRI, including whole-body MRI, as an objective outcome measure in trials in patients with psoriatic arthritis.

Introduction Le rhumatisme psoriasique (RPso) de forme oligoarticulaire (oligo) (≤4 articulations touchées), bien que fréquent, reste sous-étudié, la plupart des essais cliniques exigeant un nombre d’articulations gonflées (NAG) et douloureuses (NAD) ≥3. L’étude FOREMOST (NCT03747939) est le premier essai de phase 4 contrôlé randomisé qui démontre l’efficacité d’aprémilast (APR) vs placebo (PBO) chez les patients avec un RPso oligo récent [1]. Dans cette étude, le questionnaire Psoriatic Arthritis Impact of Disease 12 (PsAID-12) a été utilisé pour mesurer l’impact de la maladie perçu par les patients au travers de 12 items, ainsi que ses valeurs seuil d’activité de la maladie récemment décrites [2].Nous évaluons l’efficacité d’APR sur l’impact de la maladie perçu par le patient atteint d’un RPso oligo récent, mesuré par le score PsAID-12. Patients et méthodes L’étude FOREMOST a été menée auprès de patients avec un RPso récent (≤5ans) et une atteinte articulaire limitée (2–4 NAG et 2–4 NAD sur 66–68 articulations évaluées) [1]. Ils ont été randomisés entre APR et PBO (2:1) durant 24 semaines (S24), avec échappement précoce possible à S16, suivi d’une phase d’extension où tous ont reçu APR jusqu’à S48. L’évolution du PsAID-12 par rapport à l’inclusion a été calculée à S16 et S48, dans les groupes APR et PBO. La proportion de patients ayant atteint un état symptomatique acceptable pour le patient selon le PsAID-12 (PASS ; PsAID-12≤4) à S48, a également été évaluée chez ceux qui n’atteignaient pas un PASS (PsAID-12>4) à l’inclusion. En utilisant les seuils d’activité de la maladie du PsAID-12 [2], a été évaluée, jusqu’à S48, la proportion de patients atteignant REM/LDA* définie par le PsAID (PsAID-12≤1,95) et REM (PsAID-12≤1,15), chez ceux qui n’étaient ni en REM/LDA (PsAID-12>1,95), ni en REM (PsAID-12>1,15) à l’inclusion. L’analyse a porté sur les données observées.* REM/LDA : rémission ou faible activité de la maladie. Résultats Au total, 308 patients ont été randomisés (APR : n=203 ; PBO : n=105) ; la durée moyenne du RPso et du PsAID-12 étaient respectivement de 10 mois et 4,72. À S16, la variation moyenne du PsAID-12 par rapport à l’inclusion était de –1,51 avec APR et de –0,44 avec PBO ; des améliorations supplémentaires ont été observées chez les patients poursuivant APR et les patients passés du PBO à APR, jusqu’à S48 (–1,63 et –1,59, respectivement). À S16, 53,4 % (62/116) des patients qui n’avaient pas un PsAID-12 PASS à l’inclusion, l’ont atteint avec APR, contre 25,9 % (14/54) sous PBO (Figure 1A). À S16, 31,2 % (48/154) des patients qui n’étaient pas en PsAID-REM/LDA à l’inclusion, ont atteint l’objectif thérapeutique PsAID-REM/LDA avec APR, contre 13,2 % (10/76) avec PBO (Figure 1B), et 19,3 % (31/161) des patients qui n’étaient pas en PsAID-REM à l’inclusion, ont atteint un PsAID-REM avec APR, contre 7,4 % (6/81) avec PBO. Un maintien de ces améliorations a été observé chez les patients avec APR jusqu’à S48. Conclusion Le traitement par APR a permis, vs PBO, à une proportion plus importante de patients d’atteindre un état symptomatique acceptable, un état symptomatique associé à une LDA ou REM à S16, résultats maintenus à S48. Ces résultats démontrent l’efficacité d’APR pour réduire l’impact de la maladie chez les patients avec un RPso oligo récent et pourraient guider la prise de décision médicale partagée.

Psoriasis involvement in special areas (e.g., scalp or nails) is associated with a great disease burden yet it is often inadequately treated with topical treatments. The efficacy and tolerability of apremilast plus existing topical therapy in Japanese patients with mild to moderate plaque psoriasis were demonstrated in PROMINENT, a phase 3b, multicenter, open-label, single-arm study. We evaluated the efficacy of apremilast across disease severities and special areas involved in these patients. In PROMINENT, patients received apremilast 30 mg twice daily for 16 weeks in addition to their existing topical therapy, with the option of topical therapy reduction at the discretion of their physician while continuing apremilast treatment from Weeks 16 to 32. We performed a post hoc analysis, assessing apremilast efficacy and safety in Japanese patients stratified by baseline static Physician Global Assessment (sPGA) score (2 [mild] or 3 [moderate]) and special area involvement. Of patients with baseline sPGA = 2 and sPGA = 3, 62.7

Background: Genital psoriasis can be stigmatizing, is highly prevalent among patients with psoriasis, and has limited treatment options. Apremilast is a unique oral immunomodulating phosphodiesterase 4 inhibitor approved for psoriasis treatment. Objective: To assess the efficacy and safety of apremilast 30 mg twice daily in patients with genital psoriasis. Methods: DISCREET, a phase 3, placebo-controlled trial (NCT03777436), randomized patients with moderate-to-severe genital psoriasis (stratified by affected body surface area \10% or >= 10%) to apremilast or placebo for a 16-week period, followed by an apremilast extension period. Week 16 results are presented. Results: Patients were randomized to apremilast (n = 143) or placebo (n = 146). At Week 16, 39.6% and 19.5% of apremilast and placebo patients, respectively, achieved a modified static Physician Global Assessment of Genitalia response (primary endpoint; score of 0/1, >= 2 -point reduction); treatment difference was significant (20.1%, P = .0003). Improvements in genital signs and symptoms, skin involvement, and quality of life were observed. Common treatment-emergent adverse events were diarrhea, headache, nausea, and nasopharyngitis. Conclusions: Apremilast demonstrated statistically and clinically meaningful genital Physician Global Assessment responses and improvement of signs, symptoms, severity, and quality of life in this first randomized, controlled study of an oral systemic treatment in patients with genital psoriasis. ( J Am Acad Dermatol 2024;90:485-93.)

Background: Psoriatic disease and cardiometabolic conditions are connected by immune-mediated mechanisms. Apremilast is an inhibitor of phosphodiesterase 4, which modulates a broad range of inflammatory and metabolic processes.

Background: Psoriatic arthritis (PsA) is characterized by inflammatory arthritis, enthesitis, dactylitis, and spondylitis. Apremilast is an oral immunomodulating phosphodiesterase-4 inhibitor approved for treatment of PsA. Results from the MOSAIC study demonstrated that treatment with apremilast in patients with active PsA led to significant improvements in objective MRI indices of inflammation of the hand as assessed by the PsA MRI Score (PsAMRIS) [1] as well as significant reduction in total peripheral inflammation, including significant improvement in peripheral joint inflammation and enthesitis, as assessed by whole-body MRI (WB-MRI) [2]. Objectives: To evaluate the efficacy of apremilast on MRI endpoints, clinical outcomes, and patient reported outcomes (PROs) in patients with PsA treated with apremilast 30 mg BID in the MOSAIC study. Methods: MOSAIC (NCT03783026) was a phase 4, multicenter, single-arm, open-label study in patients with active PsA (≥3 months but ≤5 years since diagnosis, meeting CASPAR criteria) evaluating apremilast as monotherapy or in combination with stable methotrexate. Patients were treated with apremilast for 48 weeks and had contrast-enhanced MRI of the hand and WB-MRI performed at baseline, Week 24, and Week 48. All images were read and adjudicated by 2 experienced readers blinded to clinical information and acquisition time. MRI endpoints included change from baseline in the composite and total inflammation scores of hand bone marrow edema, synovitis, and tenosynovitis in fingers 2–5 as assessed by PsAMRIS at Weeks 24 and 48, as well as total peripheral inflammation index as assessed by WB-MRI. Clinical outcomes included change from baseline to Weeks 24 and 48 in swollen joint count (SJC), tender joint count (TJC), Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) score, and evaluator’s global assessment of disease activity. PROs included change from baseline in Psoriatic Arthritis Impact of Disease 12 items (PsAID-12), patient assessed disease activity and pain and Health Assessment Questionnaire-Disability Index (HAQ-DI score). Results: A total of 122 patients were enrolled and received apremilast. Mean age was 47 years and 55% were women. Disease duration was limited (mean 1.9 years). At baseline, mean (SD) for MRI endpoints were composite inflammation 18.5 (17.8), total inflammation 25.8 (24.2), and peripheral inflammation 28.8 (22.5); mean (SD) SJC was 8.0 (7.2), TJC 14.6 (11.3), cDAPSA 31.9 (16.5), and evaluator’s global assessment of disease activity 5.2 (1.5); mean (SD) PsAID-12 4.75 (1.87), patient’s global assessment of disease activity 5.6 (1.8), patient’s assessment of pain 5.6 (1.8), and HAQ-DI 1.01 (0.57). Apremilast treatment resulted in significant changes from baseline to Weeks 24 and 48 in the composite inflammation score and total inflammation score by PsAMRIS, and peripheral inflammation index by WB-MRI (Figure 1). Significant reductions were observed with clinical outcomes and PROs at weeks 24 and 48, including SJC, TJC, cDAPSA, evaluator’s global assessment of disease activity, PsAID-12, patient’s global assessment of disease activity, patient’s assessment of pain, and HAQ-DI (Figure 2). Conclusion: Patients with PsA treated with apremilast had significant improvements in MRI endpoints, clinical outcomes, and PROs at Weeks 24 and 48, confirming the effect of apremilast on clinical and inflammatory manifestations of PsA. These results offer important insights on the effect of apremilast in PsA and highlight the value of using MRI of the hand and whole body as measures of inflammatory disease activity and change following treatment. REFERENCES: [1] Østergaard M, et al. Ann Rheum Dis. 2023;82:341-42.[2] Østergaard M, et al. Ann Rheum Dis. 2023;82:2000-01. Acknowledgements: This clinical trial was sponsored by Amgen Inc. Medical writing support was funded by Amgen Inc. and provided by Martha Mutomba (on behalf of Amgen Inc) and Jessica Ma, employee of and stockholder in Amgen Inc. Disclosure of Interests: Philip J. Mease AbbVie, Amgen Inc., Eli Lilly, Janssen, Novartis, Pfizer, and UCB, AbbVie, Acelvrin, Amgen Inc., Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun, UCB, Aclaris, Boehringer Ingelheim, GlaxoSmithKline, Moonlake Pharma, Takeda, and Ventyx, AbbVie, Acelvrin, Amgen Inc., Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun, and UCB, Walter P Maksymowych AbbVie, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB, AbbVie, Novartis, Pfizer, and UCB, Mikael Boesen AbbVie, Celgene, Eli Lilly, Image Analysis Group, Novartis, Pfizer, and UCB, AbbVie, Celgene, Eli Lilly, Image Analysis Group, Novartis, Pfizer, and UCB, AbbVie, Celgene, and Novartis, Robert G Lambert Calyx, CARE Arthritis Limited, and Image Analysis Group, Guillermo Valenzuela AbbVie, Amgen Inc., AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, Genentech, Horizon, Janssen, Mallinckrodt, Novartis, Pfizer, Pharmacia, Radius, Regeneron, Sanofi, Takeda, and UCB, AbbVie, Alexion, Amgen Inc., Boehringer Ingelheim, Celgene, Eli Lilly, Esaote, Exagen, Genentech, Gilead, Global Health Living, Horizon, Image Analysis Group, Janssen, Merck, Novartis, Pfizer, Regeneron, Sandoz, Sanofi, and UCB, Mallinckrodt and Novartis, Michael Bubb Amgen Inc., BMS, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, and UCB, Olga Kubassova: None declared, Frank Behrens Abbvie, Pfizer, Roche, Chugai, UCB, BMS, Amgen, Celgene, MSD, Novartis, Janssen, Lilly, Sanofi, Biogen, Sandoz, GSK, Abbvie, Pfizer, UCB, BMS, Celgene, Amgen, Novartis, Janssen, Lilly, MSD, Sanofi, GSK, Abbvie, Pfizer, Roche, Chugai, Prophylix, Rallybio, BMS, Novartis, Amgen, Janssen, Jyotsna Reddy Amgen Inc, Amgen Inc, Stephen Colgan Amgen Inc, Amgen Inc, Yuri Klyachkin Amgen Inc, Amgen Inc, Cynthia Deignan Amgen Inc, Amgen Inc, Zhenwei Zhou Amgen Inc, Amgen Inc, Mikkel Østergaard Amgen Inc, Amgen IncFigure 1Improvements in MRI scores of inflammation during apremilast therapy. Figure 2Improvements in clinical disease activity scores and patient-reported outcomes during apremilast therapy.

Objectives Oligoarticular psoriatic arthritis (PsA) is frequent but rarely studied. The objective was to assess the efficacy of apremilast in early oligoarticular PsA. Methods FOREMOST (NCT03747939) was a phase 4 multicentre, randomised, double-blind, placebo-controlled trial. Patients had early (symptom duration <= 5 years) oligoarticular PsA (>1but <= 4 swollen and >1but <= 4 tender joints; 2-8 total active joints). Patients were randomised 2:1 to apremilast 30mg two times per day or placebo for 24 weeks, with an early escape at week 16. The primary endpoint was the proportion of patients at week 16 who achieved minimal disease activity (MDA)-Joints (modification of MDA mandating <= 1 swollen joint and <= 1 tender joint) based on sentinel joints (those affected at baseline) with a combination of non-responder imputation and multiple imputations. Exploratory analysis assessed all joints. Results Of 308 patients randomised (apremilast: n=203; placebo: n=105), mean (SD) PsA duration was 9.9 (10.2) months, mean (SD) age was 50.9 (12.5) years and 39.9% of patients were using a conventional synthetic disease-modifying antirheumatic drug. MDA-Joints (sentinel joints (primary endpoint) and all joints) were achieved by significantly more patients with apremilast (33.9% and 21.3%) vs placebo (16.0% and 7.9%) at week 16 (p=0.0008and nominal p=0.0028, respectively). Greater improvements in patient-reported outcomes, clinical disease activity and skin involvement were also seen with apremilast versus placebo. Conclusions FOREMOST is the first randomised controlled trial designed for early oligoarticular PsA and showed apremilast improves clinical and patient-reported outcomes. This trial may inform the optimal management of PsA in these patients.

Introduction Bien que le rhumatisme psoriasique (RPso) de forme oligoarticulaire (oligo) se caractérise par une atteinte articulaire limitée (≤4 articulations touchées), il est associé à une morbidité élevée, incluant fatigue et douleur. Le questionnaire PsAID-12, (Psoriatic Arthritis Impact of Disease) est un outil multidimensionnel de mesure des résultats rapportés par les patients qui évalue les symptômes et l’impact du RPso, en prenant en compte les caractéristiques clés de la maladie telles que la fatigue, la douleur et l’atteinte cutanée [1].Nous évaluons la fatigue et la douleur chez les patients atteints de RPso oligo récent inclus dans l’étude FOREMOST, ainsi que les bénéfices rapportés par les patients du traitement par aprémilast (APR) par rapport au placebo (PBO) pendant 48 semaines (S48). Patients et méthodes FOREMOST (NCT03747939) est une étude de phase IV, multicentrique, randomisée, en double aveugle, contrôlée vs PBO. Les patients éligibles avaient un RPso récent (≤5ans) et une atteinte articulaire limitée (2–4 articulations gonflées (NAG) et 2–4 articulations douloureuses (NAD) sur 66–68 articulations évaluées). Ils ont été randomisés entre APR et PBO (2:1) et suivis 24 semaines, avec un échappement précoce possible à S16, suivi d’une phase d’extension où tous ont reçu APR jusqu’à S48. Les PROs* analysés comprenaient les questionnaires PsAID-12 (0 [meilleur état de santé] - 10 [pire état de santé]) et Short Form (SF)-36 (échelle de 0 à 100 ; 0 [pire état de santé] - 100 [meilleure état de santé]). Les scores PsAID-12 (total, fatigue et douleur), et SF-36 relatifs à la fonction physique, à la douleur corporelle et à la vitalité sont présentés en analyse post-hoc.*Patient Reported Outcomes. Résultats Au total, 308 patients ont été randomisés (APR : n=203, PBO : n=105 dont 24 passés à APR à S16), la durée moyenne du RPso était de 9,9 mois et l’âge moyen était de 50,9ans. À l’inclusion, la plupart des patients ont signalé une activité élevée de la maladie au travers du PsAID-12 (total, fatigue et douleur) (Figure 1). Ces scores se sont améliorés dans le groupe APR, à la différence du PBO, à S16 (Fig. 2, Fig. 3). Deux fois plus de patients sous APR vs PBO ont obtenu une variation minimale cliniquement importante (MCID ; augmentation ≥3 points du score PsAID-12 Total). Le maintien de ces améliorations a été observé chez les patients sous APR ou passés du PBO à APR jusqu’à S48. Les scores SF-36 moyens de la fonction physique, de la douleur corporelle et de la vitalité pour APR vs PBO étaient respectivement de 43,2 vs 41,6, 44,4 vs 41,2 et 47,2 vs 44,4 à S16 ; ces différences se sont réduites à S48, quand tous les patients sont passés à APR (APR/APR vs PBO/APR : 44,3 vs 43,9, 45,0 vs 45,3 et 47,9 vs 47,9). À S16, plus de patients sous APR par rapport à ceux sous PBO ont atteint une MCID (augmentation ≥5 points) du score de vitalité ; cette amélioration s’est maintenue à S48 pour les patients sous APR. Conclusion Les patients atteints de RPso oligo récent recrutés dans le cadre de l’étude FOREMOST ont rapporté une activité élevée de la maladie liée à la fatigue et à la douleur, ce qui indique que ces deux caractéristiques ont un impact sur le fardeau de la maladie. Le traitement par APR a permis une amélioration de la fatigue et de la douleur avec un maintien à S48.

Background: Oligoarticular psoriatic arthritis (PsA, ≤4 joints affected), although common, is understudied, as most clinical trials require patients (pts) to have ≥3 swollen and tender joints. The FOREMOST study (NCT03747939) is the first large, phase 4, multicenter, randomized, placebo (PBO)-controlled trial to demonstrate efficacy of apremilast (APR) in clinical outcomes in pts with early oligoarticular PsA, and the first trial to investigate clinical outcomes in this pt population. Here we applied the PsA Impact of Disease (PsAID-12) Questionnaire, a 12-item pt-reported outcome measure, and its recently described cutoff values, to better understand the burden of oligoarticular PsA disease from the pt’s perspective. Objectives: To evaluate the efficacy of APR on impact of disease as measured by PsAID-12 total score in pts with early oligoarticular PsA. Methods: FOREMOST included pts with early PsA (duration ≤5 years) and limited joint involvement (>1 but ≤4 swollen and tender joint count). Pts were randomized 2:1 to APR (30 mg twice daily) or PBO for 24 wks (early escape at Wk 16), followed by an extension phase in which all pts received APR through Wk 48. The changes from baseline in PsAID-12 score were calculated at Wks 16 and 48 in both APR and PBO groups. The percentage of pts achieving a Patient Acceptable Symptom State (PASS) according to the PsAID-12 (PsAID-12 ≤4) through Wk 48 was also assessed in pts who were not in a PASS (PsAID-12 >4) at baseline. Additionally, using the PsAID-12 responder and disease activity thresholds,[1] we assessed the percentages of pts reaching PsAID-defined remission or low disease activity (REM/LDA) (PsAID-12 ≤1.95) and remission (REM) (PsAID-12 ≤1.15) when not in REM/LDA (PsAID-12 >1.95) and REM (PsAID-12 >1.15) at baseline through Wk 48. Summary is based on observed data. Results: A total of 308 pts were randomized (APR: n=203; PBO: n=105); mean PsA duration and PsAID-12 at baseline were 10 months (standard deviation [SD] 10.18) and 4.72 (2.09), respectively. At Wk 16, the mean change in PsAID-12 from baseline was −1.51 (1.9) in the APR group and −0.44 (1.9) in the PBO group; during the extension phase, pts continuing APR (APR/APR) and pts who switched from PBO to APR (PBO/APR) improved through Wk 48 (−1.63 [2.1] and −1.59 [1.8], respectively). At Wk 16, 62/116 (53.4%) of pts who were not in PsAID-12 PASS at baseline, achieved PsAID-12 PASS with APR compared with 14/54 (25.9%) in the PBO group (Figure 1A). At Wk 16, 48/154 (31.2%) of pts who were not in PsAID-REM/LDA at baseline reached the treatment goal of PsAID-REM/LDA with APR compared with 10/76 (13.2%) in the PBO group (Figure 1B), and 31/161 (19.3%) of pts who were not in PsAID-REM at baseline achieved PsAID-REM in the APR group vs 6/81 (7.4%) of control pts (Figure 1C). Through Wk 48, the APR/APR and PBO/APR groups maintained achievement of or improved in PsAID-12 PASS, REM/LDA, and REM (Figure 1). Conclusion: Greater percentages of pts with oligoarticular PsA receiving APR achieve the acceptable symptom state, symptom-based low disease activity, or symptom based-remission at Wk 16 compared with PBO and this is maintained through Wk 48. These results demonstrate the efficacy of APR on reducing the burden of oligoarticular PsA disease from the pt’s perspective. These results might inform shared decision-makings for pts with early PsA. REFERENCES: [1] Gossec L, et al. Ann Rheum Dis 2023;82(Suppl 1):565-566. (abstract). Acknowledgements: This study was funded by Amgen Inc. Writing support was funded by Amgen Inc. and provided by Corey Burgin, PhD, of Peloton Advantage, LLC, an OPEN Health company, and Shannon Rao, employee of Amgen Inc. Disclosure of Interests: Laure Gossec AbbVie, Amgen, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB – Personal fees, AbbVie, Biogen, Lilly, Novartis, UCB – Grant/research support, Laura C. Coates AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, MoonLake, Novartis, Pfizer, UCB – Speaker honoraria, AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, MoonLake, Novartis, Pfizer, UCB – Consulting fees, AbbVie, Amgen, Biogen, Bristol Myers Squibb, Celgene Corporation, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, MoonLake, Novartis, Pfizer, UCB UCB – Grant/research support, Dafna D. Gladman AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB – Consulting Fees, AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, UCB –Ggrant/research support, Alexis Ogdie AbbVie, Amgen Inc., Bristol Myers Squibb, CorEvitas’ Psoriatic Arthritis/Spondyloarthritis Registry, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer, UCB, and Takeda – Consultant, AbbVie, Amgen Inc., BMS, Janssen, Novartis, and Pfizer – Grant/research support, Peter Nash: None declared, Denis Poddubnyy AbbVie, Canon, DKSH, Eli Lilly, Janssen, MSD, Medscape, Novartis, Peervoice, Pfizer, and UCB – Speaker fees, AbbVie, Biocad, Bristol-Myers Squibb, Eli Lilly, Janssen, Moonlake, Novartis, Pfizer, and UCB – Consulting fees, AbbVie, Eli Lilly, MSD, Novartis, Pfizer – Research support, Arthur Kavanaugh AbbVie, BMS, Janssen, Moonlake, Novartis, Pfizer, Eli Lilly, UCB – Consultant, Amgen, AbbVie, BMS, Janssen, Moonlake, Novartis, Pfizer, Eli Lilly, UCB – Grant/research support, April Armstrong AbbVie, Almirall, Arcutis, ASLAN, Beiersdorf, BI, BMS, EPI, Incyte, Leo, UCB, Janssen, Lilly, Mindera, Nimbus, Novartis, Ortho Dermatologics, Sun, Dermavant, Dermira, Sanofi, Regeneron, and Pfizer – Research investigator and/or scientific advisor, Carlo Selmi AbbVie, Amgen, Alfa-Sigma, Biogen, Eli-Lilly, EUSA Pharma - Recordati, Galapagos, Janssen, Novartis, Octapharma, Pfizer, Recordati Rare Disease, SOBI – Speakers Bureau, AbbVie, Amgen, Alfa-Sigma, Biogen, Eli-Lilly, EUSA Pharma - Recordati, Galapagos, Janssen, Novartis, Octapharma, Pfizer, Recordati Rare Disease, SOBI – Consulting Fees, AbbVie, Amgen, Janssen, Novartis, Pfizer – Research Grants, Rubén Queiro AbbVie, Amgen, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, UCB – Consulting fees, AbbVie, Amgen, Celgene, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, UCB – Grant/research support, Cynthia Deignan Amgen – Stock ownership, Amgen – Employment, Rebecca Wang Amgen - Stock Ownership, Amgen - Employment, Jyotsna Reddy Amgen - Stock Ownership, Amgen - Employment, Michele Brunori Amgen - Stock Ownership, Amgen - Employment, Philip J. Mease AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, UCB – Speakers bureau, Boehringer Ingelheim, GlaxoSmithKline – Consultant, AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun, UCB – Grant/research support and consultant.Figure 1Percentage of patients with early oligoarticular PsA achieving PsAID PASS (A), REM/LDA (B), and REM (C) through week 48.

Background: Prescribing information for plaque psoriasis treatments based on clinical data provides warnings and precautions to guide providers. Commonly cited warnings pertain to malignancy and infection risk, including immunosuppression. The aim of this study was to quantify the proportion of US psoriasis patients impacted by these warnings in real-world practice.

Background: Apremilast is an oral phosphodiesterase 4 inhibitor with a unique immunomodulatory mechanism of action and is approved for the treatment of psoriatic arthritis (PsA). Although peripheral arthritis is the most frequent clinical feature in patients with PsA, axial involvement may occur in up to 50% of patients with PsA, causing inflammatory back pain, stiffness, and changes on imaging. Here, we used whole-body magnetic resonance imaging (WB-MRI) to evaluate the efficacy of apremilast 30 mg twice daily on axial inflammation in patients with PsA. Objectives: To evaluate the efficacy of apremilast on axial inflammation in PsA. Methods: The MOSAIC study was a phase 4, single-arm, open-label trial that evaluated up to 48 weeks of apremilast treatment (with or without stable methotrexate) in patients with active PsA (per Classification Criteria for Psoriatic Arthritis [CASPAR]). Contrast-enhanced WB-MRI was performed at baseline, week 24, and week 48, and images were evaluated and adjudicated by two experienced readers who were blinded to time point and response to apremilast. In patients deemed to have PsA spondylitis by the investigator and a baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Item 2 (back pain) ≥4, MRI axial inflammation was assessed by calculating the least squares mean changes from baseline to week 24 and week 48 in the Canada-Denmark (CANDEN) total spine inflammation score and subscores (assessing individual anatomical locations including posterolateral elements), the Spondyloarthritis Research Consortium of Canada (SPARCC) spine score, and the SPARCC sacroiliac joint (SIJ) inflammation score. Results: Overall, 122 patients were treated with apremilast. At baseline, the mean age was 47 years, 55% were women, mean PsA duration was 1.9 years, mean CANDEN spine score was 5.8, mean SPARCC spine score was 5.4, and mean SPARCC SIJ inflammation score was 2.7. Of the 40 patients deemed to have PsA spondylitis by the investigator and a BASDAI Item 2 ≥4, 39 patients were analyzed for axial inflammation. At weeks 24 and 48, CANDEN total spine inflammation score, vertebral body, posterior elements, corner, non-corner, and posterolateral elements inflammation subscores were significantly reduced with apremilast relative to baseline. No significant change in facet joint inflammation subscore, SPARCC spine, or SPARCC SIJ scores were observed (Figure 1). Conclusion: In patients with early PsA, apremilast reduced axial inflammation as assessed by the CANDEN MRI scoring system which provided a comprehensive and detailed anatomy-based quantification of inflammatory changes in the spine. Apremilast significantly reduced inflammation both in vertebral bodies and in posterolateral elements of the spine after 24 and 48 weeks of treatment. REFERENCES: NIL. Acknowledgements: This study was funded by Amgen Inc. Writing support was funded by Amgen Inc. and provided by Shannon Rao, PhD, employee of and stockholder in Amgen Inc. Disclosure of Interests: Mikkel Østergaard AbbVie, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, Gilead, Hospira, Janssen, MEDAC, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, AbbVie, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, Gilead, Hospira, Janssen, MEDAC, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, AbbVie, Amgen Inc., BMS, Merck, Celgene, and Novartis, Walter P Maksymowych CARE Arthritis Limited, AbbVie, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB, AbbVie, Novartis, Pfizer, and UCB, Robert G Lambert Calyx, CARE Arthritis Limited, and Image Analysis Group, Mikael Boesen AbbVie, Celgene, Eli Lilly, Image Analysis Group, Novartis, Pfizer, and UCB, Image Analysis Group, AbbVie, Celgene, Eli Lilly, Image Analysis Group, Novartis, Pfizer, and UCB, AbbVie, Celgene, and Novartis, Guillermo Valenzuela AbbVie, Amgen Inc., AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Centocor, Eli Lilly, Genentech, Horizon, Janssen, Mallinckrodt, Novartis, Pfizer, Pharmacia, Radius, Regeneron, Sanofi, Takeda, and UCB, AbbVie, Alexion, Amgen Inc., Boehringer Ingelheim, Celgene, Eli Lilly, Esaote, Exagen, Genentech, Gilead, Global Health Living, Horizon, Image Analysis Group, Janssen, Merck, Novartis, Pfizer, Regeneron, Sandoz, Sanofi, and UCB, Mallinckrodt and Novartis, Michael Bubb AbbVie, Celgene, Eli Lilly, Image Analysis Group, Novartis, Pfizer, and UCB, Image Analysis Group, AbbVie, Celgene, Eli Lilly, Image Analysis Group, Novartis, Pfizer, and UCB, AbbVie, Celgene, and Novartis, Olga Kubassova Image Analysis Group, Image Analysis Group, Xenofon Baraliakos Abbvie, Amgen, BMS, Chugai, Galapagos, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, and UCB, Novartis and Abbvie, Carlo Selmi AbbVie, Amgen, Alfa-Sigma, Biogen, Eli-Lilly, EUSA Pharma - Recordati, Galapagos, Janssen, Novartis, Octapharma, Pfizer, Recordati Rare Disease, and SOBI, AbbVie, Amgen, Alfa-Sigma, Biogen, Eli-Lilly, EUSA Pharma - Recordati, Galapagos, Janssen, Novartis, Octapharma, Pfizer, Recordati Rare Disease, and SOBI, AbbVie, Amgen, Janssen, Novartis, and Pfizer, Stephen Colgan Amgen Inc, Amgen Inc, Yuri Klyachkin Amgen Inc., Amgen Inc., Cynthia Deignan Amgen Inc., Amgen Inc., Zhenwei Zhou Amgen Inc., Amgen Inc., Philip J. Mease AbbVie, Amgen Inc., Eli Lilly, Janssen, Novartis, Pfizer, and UCB, AbbVie, Amgen Inc., Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun, UCB, Boehringer Ingelheim and GlaxoSmithKline, AbbVie, Amgen Inc., Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun, and UCB,Figure 1LS mean changes from baseline to weeks 24 and 48 in CANDEN spine total score and component subscores, SPARCC spine score, and SPARCC SIJ score.

Background: In the global UPLIFT survey, patients with psoriasis in special areas (face, scalp, palms/soles, nails, genitals) and limited skin involvement reported high disease burden. We evaluated the impact of special area involvement on quality-of-life (QoL).