Psoriatic arthritis (PsA) is a chronic musculoskeletal disease that affects 0.1%-1% of the general population and about 20% of patients with psoriasis. Patients with PsA have a multifaceted pain experience, which depends on various factors, including joint inflammation, as well as peripheral and central pain sensitization. Although chronic pain is the most common symptom of PsA, few is known about the mechanisms driving it. From this point of view, the interactions between immune cells and nociceptors in the context of inflammation-related pain are emerging as a hot topic. Many studies suggested that IL-23/IL-17 pathway may play a pivotal role in this regard. This is consistent with data currently available regarding Guselkumab in PsA. Indeed, according to DISCOVER 1 and DISCOVER 2, two randomized phase III trials, patients receiving Guselkumab achieved, among others, minimal disease activity state, significant improvement in the SF-36 physical component score, and visual analog scale of pain. This study proposal aims to evaluate the potential role of Guselkumab in modulating pain perception in PsA patients from a molecular, cellular, and electrophysiological point of view.
A man or a woman at least 18 and no more than 80 years of age;
Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months the enrolment and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening;
Inadequate response or intolerance of standard treatment (namely, methotrexate and/or TNF inhibitors);
At least 3 months of non-biologic DMARDs (limited to methotrexate ≤25 mg/week, sulfasalazine ≤3 g/day, hydroxychloroquine ≤400 mg/day, and leflunomide ≤20mg/day) or at least 4 weeks of NSDAIDs for psoriatic arthritis;
Diagnosis of fibromyalgia according to ACR 2016 criteria;
Subjects with inflammatory diseases that might confound the evaluations of benefit of Guselkumab therapy, including but not limited to RA, axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease;
Patients who received more than 2 anti-TNFα agents; - Has received an anti-TNF agent within the following timeframes: Infliximab (or its biosimilars) or golimumab (intravenous) within 8 weeks before the first administration Guselkumab; Golimumab (subcutaneous), adalimumab (or its biosimilars) or certolizumab pegol within 6 weeks before the first administration of study agent; Etanercept (or its biosimilars) within 4 weeks before the first administration of study agent;
Has previously been treated with Guselkumab; - Diagnosis of psychiatric disorder according to DSM-V; - Pregnancy or lactation;