A Study of Guselkumab in Participants With Psoriatic Arthritis (PsA) in a Real-World Setting

Enthesitis is assessed by ultrasound using the Global Outcome Measures in Rheumatology (OMERACT) enthesitis score which scores 6 pairs of entheses bilaterally: common extensor tendon, quadriceps tendon, patellar tendon at proximal and distal insertion, achilles tendon and plantar aponeurosis. Each affected entheses out of the 6 bilateral sites will be scored according to OMERACT enthesitis composite semiquantitative scale (range 0-3) and the sum of each single abnormal site of the 6 bilateral targeted entheses is represented by Global OMERACT score ranging from 0-48. A higher score indicates more active disease activity.

The SPARCC developed a measure for enthesitis in general spondyloarthritis which focuses on the clinical evaluation and validation of the following 16 entheseal sites: greater trochanter (Right/Left); quadriceps tendon insertion into the patella (Right/Left); patellar ligament insertion into the patella and tibial tuberosity (Right/Left); achilles tendon insertion (Right/Left); plantar fascia insertion (Right/Left); medial epicondyles (Right/Left); lateral epicondyles (Right/Left); supraspinatus insertion (Right/Left). Each entheseal site is assessed for tenderness on a dichotomous basis, i.e., 0= non-tender, 1= tender, for a total score ranging from 0 to 16. Higher scores indicate more severe enthesitis. Negative changes from baseline indicate improvement of enthesitis.

DAPSA assesses the joint domain of PsA where a higher score indicates more active disease activity. DAPSA remission indicates DAPSA score of 4 or less. DAPSA remission signifies a greater reduction in disease activity, with minimal or no symptoms when compared with DAPSA LDA.

DAPSA assesses the joint domain of PsA where a higher score indicates more active disease activity. DAPSA remission indicates DAPSA score of 4 or less. DAPSA LDA indicates DAPSA score of 14 or less. DAPSA remission signifies a greater reduction in disease activity, with minimal or no symptoms when compared with DAPSA LDA.

MDA status is defined by meeting 5 of 7 criteria: tender joint count <= 1; swollen joint count <=1; psoriasis area and severity index (PASI) <=1 or body surface area (BSA) with PsO <=3 percent (%); participant's VAS pain score of <=15; participant's VAS global disease activity score of <=20; disability index of the health assessment questionnaire (HAQ-DI) score <=0.5; and tender entheseal points <=1.

The pain VAS is a self-administered assessment of average pain during the past week. The scale ranges from "no pain" (0 mm) to "the worst possible pain" (100 mm). Higher scores indicate more pain.

HAQ-DI is used to assess the long-term influence of chronic disease on a participant's level of functional ability and activity restriction. The HAQ-DI includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. For each question the score is from 0 (without any difficulty) to 3 (unable to do) where lower scores are indicative of better functioning and higher score reflects worse function.

Number of participants who were persistent with guselkumab treatment up to 52 weeks after initiation will be reported.

An AE is any untoward medical occurrence in a participating patient administered a medicinal product. An AE does not necessarily have a causal relationship with the treatment.