The efficacy of biologic medications in improving depressive symptoms in patients with psoriasis and PsA – Patient-level meta-analysis of randomized clinical trials data

The efficacy of biologic medications in improving depressive symptoms in patients with psoriasis and PsA – Patient-level meta-analysis of randomized clinical trials data

None

Background: Depression is a chronic mood disease that can have significant impacts on quality of life, function and the development of other medical conditions. Depression can have a significant effect on the course of other diseases including psoriasis and psoriatic arthritis (PsA). Psoriasis is common inflammatory skin disorder affecting 2-4% of the population. PsA is a chronic and often debilitating inflammatory arthritis affecting nearly one third of patients with psoriasis. Psoriatic disease (PsD), including both psoriasis and PsA, is strongly associated depression. Up to a third of people with PsD are affected by depression and the severity of arthritis and psoriasis are associated with the development of depression. Some studies suggest that improvement in inflammation in the skin and the joints may improve depressive symptoms in patients with PsD. However, there has been concerns related to the development of depression during the development phases of some of the medications for PsD. Currently, there is little data about the effect of the different classes of medications used for the treatment of psoriasis and PsA on depressive symptoms. Studying the effect of different classes of medication on depression could help in selecting the appropriate drug for patients with PsD who are affected by depression. Aim: To compare the effect of three classes of medications used for the treatment of PsD in improving depressive symptoms among patients with PsA and psoriasis participating in clinical trials. The three classes of medications include: TNF inhibitors, IL-12/IL-23 inhibitors and IL-17 inhibitors.Study design: In this study we will combine data from clinical trials that assessed the effect of the following drugs for the treatment of PsD: certolizumab (TNF inhibitor), secukinumab (IL-17 inhibitor), golimumab (TNF inhibitor), ixekizumab (IL-17 inhibitor), ustekinumab (IL-12/IL-23 inhibitor). The study outcome will be the change in depressive symptoms that will be measured by a component of a quality of life questionnaire. This questionnaire has been administered to the patients in the clinical trial at the initiation of the study and at regular time periods. We will compare the degree of change in depression between the study drug and the placebo group in each study and then compile the results of several studies to determine whether there is a difference in the effect on depressive symptoms across drug classes. The results of the study will assist physicians treating patients with PsD in selecting the appropriate class of medications depending on the presence of depression. The results of the study will be published in medical journals and in websites open to the general public (clinicaltrials.gov).

[{ "PostingID": 2366, "Title": "UCB-PsA001", "Description": "Certolizumab Pegol in Subjects With Adult Onset Active and Progressive Psoriatic Arthritis" },{ "PostingID": 3953, "Title": "NOVARTIS-CAIN457A2211", "Description": "A Randomized, Double-blind, Placebo Controlled, Multicenter Regimen Finding Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis" },{ "PostingID": 3955, "Title": "NOVARTIS-CAIN457A2220", "Description": "A Randomized, Double-blind, Placebo Controlled, Multicenter Dose Ranging Study of Subcutaneously Administered AIN457, Assessing Psoriasis Area and Severity Index (PASI) Response in Patients With Moderate to Severe Chronic Plaque-type Psoriasis" },{ "PostingID": 4451, "Title": "LILLY-I1F-MC-RHAJ", "Description": "A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis" },{ "PostingID": 4452, "Title": "LILLY-I1F-MC-RHAZ", "Description": "A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis UNCOVER-1" },{ "PostingID": 4453, "Title": "LILLY-I1F-MC-RHBA", "Description": "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis. UNCOVER-2" },{ "PostingID": 4454, "Title": "LILLY-I1F-MC-RHBC", "Description": "A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period UNCOVER-3" },{ "PostingID": 4601, "Title": "NOVARTIS-CAIN457A2302", "Description": "A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

Medicine: secukinumab, Condition: Psoriasis, Phase: 3, Clinical Study ID: CAIN457A2302 , Sponsor: Novartis." },{ "PostingID": 4602, "Title": "NOVARTIS-CAIN457A2303", "Description": "A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis

Medicine: secukinumab , Condition: Psoriasis, Phase: 3, Clinical Study ID: CAIN457A2303 , Sponsor: Novartis." }]