scholarly journals BMS-986165, an Oral, Selective TYK2 Inhibitor, in the Treatment of Moderate to Severe Psoriasis as Assessed by the Static Physician's Global Assessment (sPGA)/Body Surface Area (BSA) Composite Tool (sPGAxBSA), a Clinically Useful Alternative to PASI

2020 ◽  
Vol 4 (5) ◽  
pp. s29
Author(s):  
Alice B Gottlieb ◽  
Bruce Strober ◽  
Diamant Thaçi ◽  
Kenneth Gordon ◽  
Sundeep Kundu ◽  
...  

Abstract not available.

Dermatology ◽  
2019 ◽  
Vol 235 (4) ◽  
pp. 348-354 ◽  
Author(s):  
Alice B. Gottlieb ◽  
Rebecca Germino ◽  
Vivian Herrera ◽  
Xiangyi Meng ◽  
Joseph F. Merola

Background/Aims: In the treat-to-target era, psoriasis disease activity measures that can be easily performed in routine clinical practice are needed. This retrospective pooled analysis explored cutoff values of the product of the 5-point Investigator’s Global Assessment and percentage of affected body surface area (IGA × BSA) correlating with achievement of minimal disease activity (MDA). Methods: Post hoc analysis of the phase 3 clinical trials ERASURE, FIXTURE, FEATURE, and JUNCTURE was conducted to determine associations between IGA × BSA and 2 MDA definitions (Psoriasis Area and Severity Index [PASI] 90 and Dermatology Life Quality Index [DLQI] 0/1, or PASI score ≤1 or BSA <3%) in patients with moderate-to-severe psoriasis receiving secukinumab 300 mg. For each definition of MDA, a range of possible cutoff values of IGA × BSA was examined at each time point. The optimal cutoff value was determined using Youden index (YI), calculated as (sensitivity + specificity – 1). Results: For MDA defined as PASI 90 and DLQI 0/1, optimal IGA × BSA cutoffs were 2.10 at week 12 (YI, 0.60; sensitivity, 0.78; specificity, 0.82), 1.02 at week 24 (YI, 0.55; sensitivity, 0.73; specificity, 0.82), and 1.00 at week 52 (YI, 0.65; sensitivity, 0.79; specificity, 0.86). For MDA defined as PASI score ≤1 or BSA <3%, optimal IGA × BSA cutoffs were 2.98 at week 12 (YI, 0.91; sensitivity, 0.99; specificity, 0.92), 2.80 at week 24 (YI, 0.94; sensitivity, 0.99; specificity, 0.95), and 3.00 at week 52 (YI, 0.96; sensitivity, 1.00; specificity, 0.96). Conclusion: IGA × BSA could be a valid measure highly associated with achievement of MDA.


2017 ◽  
Vol 44 (5) ◽  
pp. 691-692 ◽  
Author(s):  
Joseph F. Merola ◽  
Alice B. Gottlieb

At the 2016 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), we presented the case for quantitatively assessing the extent of both psoriasis and psoriatic arthritis in the clinical setting, with a particular focus on the validation and expanded novel use of the PGAxBSA (static physician’s global assessment × body surface area of involvement) in the era of targeted metrics. Herein, we summarize our presentation.


2020 ◽  
Vol 5 (4) ◽  
pp. 160-163
Author(s):  
Eingun James Song

Background: Chronic kidney disease is a relative contraindication for conventional systemic therapy in patients with psoriasis. Although biologic agents may be suitable in these patients due to their elimination via endogenous metabolism and protein degradation, no dedicated studies have evaluated the safety of biologics in patients with psoriasis and chronic kidney disease. Tildrakizumab—an anti-interleukin-23p19 monoclonal antibody—is approved for treatment of moderate-to-severe plaque psoriasis. Objective: To evaluate efficacy and safety of tildrakizumab in a 56-year-old woman with moderate-to-severe plaque psoriasis and comorbid immunoglobulin A nephropathy. Methods: Subcutaneous tildrakizumab 100 mg was administered at weeks 0, 4, 20, 33, and 48. Assessments included body surface area affected, physician’s global assessment score, and laboratory assessments. Results: At initial presentation, patient had predominantly plaque-type psoriasis involving 5% body surface area with a static physician’s global assessment score of 3. Patient failed an adequate trial of ultrapotent topical steroids. Baseline laboratory tests confirmed renal impairment with blood creatinine level of 2.0 mg/dL and an estimated glomerular filtration rate of 27.0 mL/min/1.73 m2. Administration of subcutaneous tildrakizumab 100 mg led to near-complete skin clearance by week 33, with a durable response to week 48. No treatment-related adverse events were reported through 48 weeks. Metabolic and hematological parameters remained grossly unchanged. Conclusion: Tildrakizumab was well tolerated and effective for treatment of moderate-to-severe plaque psoriasis in a patient with comorbid immunoglobulin A nephropathy.


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