REAL WORLD SKIN CLEARANCE RATES FOR BIOLOGIC TREATMENTS IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS- INTERIM RESULTS FROM A LARGE PROSPECTIVE, OBSERVATIONAL STUDY

Author(s)

Paul C1, Bewley A2, Girolomoni G3, Reich K4, Puig L5, Lacour JP6, Augustin M7, Naldi L8, Menter AM9, Wade S10, Viswanathan HN11, Palmer K11, Klekotka P11, Woolley JM12
1Paul Sabatier University, Toulouse, France, 2Whipps Cross University Hospital & the Royal London Hospital, London, UK, 3Università di Verona, Verona, Italy, 4Dermatologikum Hamburg, Hamburg, Germany, 5Hospital de la Santa Creu i Sant Pau and Universitat Autònoma de Barcelona, Barcelona, Spain, 6CHU de Nice - Hôpital l'Archet 2, NICE CEDEX 3, France, 7University Medical Center Hamburg-Eppendorf, Hamburg, Germany, 8Centro Studi GISED, Bergamo, Italy, 9Texas Dermatology Associates, Dallas, TX, USA, 10Wade Outcomes and Research Consulting, Salt Lake City, UT, USA, 11Amgen Inc., Thousand Oaks, CA, CA, USA, 12Amgen Inc., South San Francisco, CA, USA

OBJECTIVES: Biologic therapies are approved for moderate/severe plaque psoriasis.  In trials of newer biologics, many patients achieved complete skin clearance.  This abstract reports interim results from a study examining real-world effectiveness of biologics in psoriasis. METHODS: This prospective observational study includes adults initiating biologic treatment, or switching to a new biologic, for psoriasis in Europe and the US.  Dermatologist evaluation of the Psoriasis Area and Severity Index (PASI) and the patient-reported Psoriasis Symptom Index (PSI] and Dermatology Life Quality Index (DLQI) are collected at baseline, 6 and 12 months after biologic initiation. Endpoints include complete skin clearance (100% improvement in PASI [PASI 100] or PASI=0), PASI 90, PASI 75, PSI and DLQI. Missing data are imputed using the last observation carried-forward.   These interim results include patients who had the opportunity to complete a 6-month assessment. RESULTS: This interim analysis included 126 patients (69.8% male, mean [SD] age 47.3 [14.3] years, mean [SD] psoriasis duration 17.3 [12.9] years).  At baseline, mean (SD) PASI was 14.8 (9.4), and 53.2% patients were biologic-naïve.  At 6-months, 17.5% [95% CI: 11.3%, 25.2%] of patients achieved complete skin clearance; fewer than half (48.0% [39.0%, 57.1%]) achieved a PASI 75, 28.0% [20.3%, 36.7%] achieved a PASI 90, and 17.6% [11.4%, 25.4%] a PASI 100.  In addition, 16.8% of patients had a PSI of 0 and 23.8% a DLQI of 0 (lower scores indicate fewer psoriasis symptoms and better quality of life).  CONCLUSIONS: Fewer than 20% of patients achieved complete skin clearance 6 months after initiating a biologic and less than half achieved a 75% improvement in PASI.  In addition, more than 75% of patients reported some decrement to quality of life and more than 80% reported psoriasis symptoms.  These results suggest that more effective treatments could improve outcomes for many patients with moderate to severe psoriasis.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PSS77

Topic

Study Approaches

Topic Subcategory

Registries

Disease

Sensory System Disorders

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