Efficacy Of Guselkumab In Patients Research Articles

S847 Efficacy of Guselkumab in Patients With Moderately to Severely Active Crohn’s Disease Not in Clinical Response at Week 12: Results From the GALAXI 1 Study

S847 Efficacy of Guselkumab in Patients With Moderately to Severely Active Crohn’s Disease Not in Clinical Response at Week 12: Results From the GALAXI 1 Study

Real-life efficacy of guselkumab in patients with early psoriatic arthritis.

To assess the efficacy of the novel anti-IL-23 monoclonal antibody guselkumab in a real-life observational cohort of patients with early PsA. We conducted an observational study on patients with early PsA followed by the joint dermatology-rheumatology clinics of two Italian centres starting therapy with guselkumab for severe skin involvement. Each patient was evaluated at baseline and every 24 weeks for one year, recording Disease Activity Index for PsA (DAPSA), PASI, VAS Pain, VAS Prutitus, Patient's Global Assessment (PtGA) and assessing DAPSA response. Twenty-four patients were recruited (16 women). The mean duration of skin disease was 12.5 years (CI 8; 17), but all patients had a shorter articular disease duration, 21.29 months (CI 15.9; 26.68). At baseline, all patients displayed a moderate cutaneous disease with a mean PASI of 15.2 (CI 11.7-18.6) and high disease activity, characterized by mean DAPSA of 26.84 (CI 22.49-31.19). An inflammatory low back pain was reported by five patients (20%) with a mean BASDAI 5.1 (CI 4,38-5,85) at baseline. The majority of guselkumab-treated patients (n = 18; 75%) reached DAPSA remission or DAPSA low disease activity after six months. Seventeen out of 24 patients completed 12 months of treatment, 11 of them (65%) in low disease activity, six (35%) in remission. All patients with axial disease reported improvement of inflammatory low back pain at week 24 with a mean BASDAI 2.98 (CI 2,18- 3,77). No significant side effects were reported. Real-life data on a cohort of early PsA patients confirm the efficacy and safety of guselkumab on peripheral and axial manifestations.

Emerging Insights in the Treatment of Psoriasis and Psoriatic Arthritis

Guselkumab is a monoclonal antibody targeting IL-23 that is approved for the treatment of patients with moderate-to-severe plaque psoriasis. Two of the posters reviewed in this article provide new insights into the clinical efficacy of guselkumab in patients with plaque psoriasis from the VOYAGE trials, firstly among those previously failing to respond to adalimumab and secondly in the setting of drug withdrawal and subsequent retreatment. In addition, data from a study reporting 56-week results from a Phase IIa study exploring the efficacy and safety of guselkumab in patients with psoriatic arthritis (PsA) are reviewed. The article concludes with a summary of the results of a survey highlighting the potential importance of evaluating gastrointestinal (GI) signs and symptoms during the management of patients with psoriasis.

Targeting p19 as a treatment option for psoriasis: an evidence-based review of guselkumab.

Further understanding of psoriasis pathogenesis has led to the development of effective biologic medications. Guselkumab (GUS) is a subcutaneously administered monoclonal antibody that targets the p19 cytokine subunit in IL-23 and IL-39 and is US Food and Drug Administration (FDA) approved for the treatment of moderate-to-severe psoriasis in adult patients. This review evaluates the pharmacology, safety and efficacy of GUS in patients with psoriasis. We performed a literature review by searching online databases including PubMed and Google Scholar. In clinical trials, GUS improved diseases including psoriatic arthritis (PsA) and specific areas of disease (scalp, feet, hands and fingernails). In the Phase III trials VOYAGE 1 and 2, more GUS than adalimumab (ADM) patients experienced a ≥90% reduction in Psoriasis Area and Severity Index (PASI) score (PASI90) (VOYAGE 1: 80.2% vs 53.0%; VOYAGE 2: 75.2% vs 54.8%; P<0.001 for both) and Investigator Global Assessment score of 0 or 1 (VOYAGE 1: 84.2% vs 61.7%; VOAYGE 2: 83.5% vs 64.9%; P<0.001 for both) at Week 24. GUS was also successful in treating patients unresponsive to ADM and ustekinumab in the VOYAGE 2 and NAVIGATE trials, respectively. While long-term data are necessary, GUS appears to have a favorable side effect profile with most common adverse effects including nasopharyngitis and upper respiratory tract infections. GUS is a well-tolerated and effective medication for patients with psoriasis. Continued study of GUS and the p19 subunit will help to determine GUS’s ultimate place in therapy.

Efficacy of guselkumab in patients with moderate-to-severe plaque psoriasis with involvement of the scalp, nails, hands, and feet: Results from the phase 3 VOYAGE 2 study

Efficacy of guselkumab in patients with moderate-to-severe plaque psoriasis with involvement of the scalp, nails, hands, and feet: Results from the phase 3 VOYAGE 2 study