Ortho Dermatologics, a division of Valeant Pharmaceuticals North America, LLC, shared the results from an analysis of the Phase 3 clinical trial AMAGINE-1, which evaluated mental health comorbidities associated with psoriasis, such as anxiety and depression. These findings were presented for the first time at the 76th Annual Meeting of the American Academy of Dermatology (AAD), Feb. 16-20, 2018, in San Diego.
“Anxiety and depression occur more frequently among patients with psoriasis than the general population,” says Dr. Melinda Gooderham, medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, in a release. “The data from AMAGINE-1 demonstrated that patients who switched from placebo to SILIQ had lower scores for disease-related anxiety and depression.”
Results from the Phase 3, randomized, controlled clinical trial AMAGINE-1 suggested that treatment with SILIQ reduced anxiety and depression in patients with moderate to severe plaque psoriasis. In the study, hospital anxiety and depression scale (HADS) scores were measured at baseline and at 12, 24, 36 and 52 weeks in patients treated with SILIQ (210 mg) or placebo. After 12 weeks of SILIQ treatment, patients experienced a decrease in depression and anxiety HADS scores (mean scores decreased by 2.1 and 1.8, respectively) while scores remained unaffected in those receiving placebo. Improvement in depression and anxiety HADS scores were also seen in patients who switched from placebo to SILIQ after a 12 week induction phase (mean scores decreased by 2.3 and 1.7, respectively), but worsened in patients who switched from SILIQ to placebo.
Also presented at the meeting was a pooled analysis of the Pivotal Phase 3 clinical trials AMAGINE-1, -2 and -3, which demonstrated that the safety profile of SILIQ at year two of treatment for patients with moderate-to-severe psoriasis was similar to its safety profile at year one of treatment. In total, 15 abstracts, including six oral presentations and nine poster presentations, will be presented on SILIQ.
SILIQ is indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. SILIQ has a Black Box Warning and a Risk Evaluation and Mitigation Strategy (REMS) due to observed suicidal ideation and behavior in clinical trials. SILIQ is contraindicated in patients with Crohn's disease. Serious infections have occurred; therefore caution should be exercised when considering the use of SILIQ in patients with a chronic infection or a history of recurrent infection. Patients should be evaluated for tuberculosis infection prior to initiating treatment and avoid use of live vaccines.
“The robust research being presented at AAD continues to deepen our understanding of the potential of SILIQ and reinforces our commitment to addressing patient needs,” says Bill Humphries, executive vice president of Dermatology, Ortho Dermatologics. “Plaque psoriasis is a chronic condition that often requires lifelong management, and we are encouraged by the consistent safety profile of SILIQ during the second year of treatment.”