The purpose of this study is to assess how well guselkumab works in improving symptoms of psoriatic arthritis (an inflammatory disease that affects the joints in participants with psoriasis, a skin condition that causes red, scaly patches) using muscoloskeletal ultrasound (MSUS) in a real-world setting.
Diagnosis of PsA as per CASPAR classification criteria for at least six months with active PsA defined as a tender joint count (TJC) greater than or equal to (>=) 3/68 and a swollen joint count (SJC) >= 3/66 at baseline, or C-reactive protein (CRP) >=0.3 milligrams per deciliter (mg/dL) if TJC and/or SJC are less than (<) 3
a) Total synovitis power doppler ultrasound (PDUS) score >=2 and inflammation related to power doppler (PD) signal >=2 for at least 1 affected joint of 48 joints at the baseline visit (before first Guselkumab administration), or b) Total synovitis PDUS score >=2 and inflammation related to PD signal >=1 for at least 2 affected joints of 48 joints at the baseline visit (before first Guselkumab administration)
Start guselkumab for the indication of PsA as part of standard clinical practice at the time of enrollment into the observational study or within a maximum of two weeks after the initial baseline visit
Participants must be biologic-naïve or previously exposed to only one biologic Disease-Modifying Antirheumatic Drugs (bDMARD) and/or apremilast/deucravacitinib
Previous exposure to Guselkumab or to more than one bDMARD for any indications
Prior treatment with Janus kinase (JAK) inhibitors
Contraindications to Guselkumab as per the summary of product characteristics (SmPC)
Current enrollment in other investigational study or participation in other investigational study completed from less than 30 days
The study population will include participants affected with PsA according to classification for psoriatic arthritis (CASPAR) criteria.
Cohort
Prospective
Not listed
Percentage Reduction From Baseline in Global OMERACT and EULAR Synovitis Score (GLOESS) at Week 12
GLOESS is an ultrasound scoring system to assess the presence and severity of synovitis measured for 24 pairs of joints. The scoring is from 0 to 3 for each joint where 0: No abnormalities or changes, 1: Mild changes, 2: Moderate changes and 3: Severe changes. The total score for 48 joints can range from 0 to 144, where higher score indicates more inflammation.
Percentage of Participants Achieving Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity (LDA) Score Less Than or Equal to 14, at Week 24
Percentage of participants achieving DAPSA LDA (that is, a score less than or equal to \[\<=\] 14) will be reported. DAPSA assesses the joint domain of PsA and is derived from the sum of the following components: Participant's assessment of pain on visual analog scale (VAS ; 0-10 centimeters \[cm\]; VAS 0= excellent; 10= poor), Participant's global assessment of disease activity on VAS (0 to 10 cm VAS, 0=excellent and 10=poor), tender joint count (0-68), swollen joint count (0-66) and C-reactive protein (CRP) level. A higher score indicates more active disease activity.
Percentage of Participants Achieving Resolution of Enthesitis by Ultrasound at Week 12
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.
Percentage Reduction from Baseline in Spondyloarthritis Research Consortium of Canada (SPAARC) Index at Week 24
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.
Percentage of Participants Achieving DAPSA Remission at Week 24
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.
Percentage of Participants Achieving DAPSA LDA/Remission at Week 52
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.
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