Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients

The primary aim of the trial will be to determine, among psoriatic arthritis (PsA) patients with an inadequate response (IR) to a tumor necrosis factor inhibitor (TNFi), whether switching to a new mechanism of action (MOA), specifically guselkumab (GUS), a selective interleukin 23 inhibitor (IL23i) targeting the p19 subunit, is more effective than switching to another TNFi. The primary hypothesis of this study is that switching to a new MOA may be more effective than switching to a second TNFi. This will be the first trial to test such a switch in PsA patients. Additionally, the proposed study will address the effectiveness of a new therapy, GUS, in a clinical practice setting among patients who are TNF IR.

Primary Outcome Measures

1. Achievement of cDAPSA low disease activity
   Clinical Disease Activity in Psoriatic Arthritis (cDAPSA): a combination score of tender joint count, swollen joint count, patient assessment of pain, and patient global assessment of disease activity. Scale from 0-154 where higher figures indicate worse status. Remission is considered ≤4 and low disease activity \>4 to ≤13.
2. Investigator Global Assessment of Psoriasis of Clear or Almost Clear
   Investigator global assessment (IGA) of psoriasis. A scale of 0-4 where higher figures indicate worse status. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).

Secondary Outcome Measures

1. Minimal Disease Activity (MDA) using PSAID-12
   Minimal Disease Activity (MDA) defines a satisfactory state of disease activity that includes 5 domains of PsA. 5/7 of the following criteria must be satisfied for MDA: patient global ≤ 2 (0-10), patient pain ≤ 2 (0-10), PSAID-12 \<4 (0-10), TJC (Tender Joint Count) ≤ 1, SJC (Swollen Joint Count) ≤ 1, BSA (Body Surface Area) ≤ 3, and Leeds Enthesitis Index ≤ 1.
2. Minimal Disease Activity (MDA) using HAQ-DI
   (MDA) Minimal Disease Activity defines a satisfactory state of disease activity that includes 5 domains of PsA. Participant would need to achieve 5/7 of the following criteria: patient global ≤ 2 (0-10), patient pain ≤ 2 (0-10), HAQ-DI (Health Assessment Questionnaire Disability Index) \< 0.5 (0-3), TJC (Tender Joint Count) ≤ 1, SJC (Swollen Joint Count) ≤ 1, BSA (Body Surface Area) ≤ 3, and Leeds Enthesitis Index ≤ 1.
3. Change in PSAID-12
   Psoriatic Arthritis Impact of Disease Questionnaire 12-item questionnaire (PSAID-12) Survey. The range of the final PsAID-12 value is 0-10 where higher figures indicate worse status. Negative changes from baseline indicate improvement in disease activity.
4. PSAID-12 < 4
   Psoriatic Arthritis Impact of Disease Questionnaire 12-item questionnaire (PSAID-12) Survey. The range of the final PsAID-12 value is 0-10 where higher figures indicate worse status.
5. Change in DLQI
   Dermatology Life Quality Index (DLQI) is a measure of skin disease activity. Calculated score of 0-30 where higher figures indicate worse status.Negative changes from baseline indicate improvement in disease activity.
6. IGA Among Patients with BSA > 3% at Baseline
   Investigator global assessment (IGA) of psoriasis among patients with BSA (Body Surface Area) \&gt;3% at baseline. A scale of 0-4 where higher figures indicate worse status. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).
7. IGA Among Patients with IGA ≥ 2 at Baseline
   Investigator global assessment (IGA) of psoriasis among patients with IGA of 2 or more (&ge; 2) at baseline. A scale of 0-4 where higher figures indicate worse status. (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe).
8. Change in Promis Fatigue
   Promis Fatigue is a measure of fatigue with a score from 8-40 where higher figures indicate worse status. A negative change indicates less overall fatigue.
9. Resolution of Dactylitis
   Dactylitis is assessed using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. These results are summed to produce a final score ranging from 0 to 20. A higher score indicates more severe dactylitis. Resolution of dactylitis is defined as a dactylitis score of 0 with a baseline dactylitis score \&gt;0.
10. Resolution of Enthesitis
    Enthesitis is assessed using the Leeds Enthesitis Index (LEI). This measure includes the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The total LEI score of 0-6 is based on evaluating each of these six sites as 0 or 1 based on the absence or presence of pain/tenderness. Resolution of enthesitis is defined as a enthesitis score of 0 with a baseline enthesitis score \&gt;0.
11. Change in BASDAI
    Change in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) among patients with axial disease. The BASDAI sum score ranges from 0 to 10 and higher values indicate more active disease. Negative changes from baseline indicate improvement in disease activity.