Search

Background: Patients treated with tumour necrosis factor (TNF) inhibitors are at risk of new‐onset tuberculosis (TB) or reactivation of latent tuberculosis infection (LTBI). Association between TB/LTBI and interleukin (IL)‐23 inhibitors for psoriasis is unclear. Patients with LTBI typically initiate LTBI therapy before receiving biologics. Objectives: Safety in moderate‐to‐severe psoriasis patients with LTBI treated with guselkumab (IL‐23 inhibitor) and LTBI treatment was evaluated. Methods: In the VOYAGE 1 & VOYAGE 2 studies, patients screened for LTBI were randomized to guselkumab, placebo, or adalimumab (TNF inhibitor) at baseline. Placebo → guselkumab crossover occurred at week 16 and adalimumab → guselkumab at week 52 (VOYAGE 1), or at week 28 or later (VOYAGE 2). Incidence of active TB, adverse events (AEs), serious AEs (SAEs), and markedly abnormal liver function tests [alanine aminotransferase test (ALT); aspartate aminotransferase test (AST)] were evaluated using pooled data through week 100 in guselkumab‐treated patients receiving and not receiving LTBI treatment. Results: At baseline, 130 randomized patients (guselkumab: n = 69; adalimumab: n = 36; placebo: n = 25) tested positive for LTBI and received concomitant LTBI treatments (LTBI+). No active TB was reported among guselkumab‐treated patients without LTBI (LTBI−) through week 100. Two cases of active TB occurred in LTBI− patients treated with adalimumab. Through week 16, across all treatment groups, greater proportions of LTBI+ patients reported ALT and AST elevations compared with LTBI− patients. Through week 100, proportions of patients experiencing AEs and SAEs were comparable between LTBI+ and LTBI− patients. Conclusions: No cases of active TB, including reactivation of LTBI, were reported in patients with or without LTBI treated with guselkumab through up to 2 years. LTBI treatment was effective across all treatment groups in preventing reactivation of LTBI. Long‐term treatment with guselkumab was generally well‐tolerated through up to 2 years in patients receiving LTBI medications. [ABSTRACT FROM AUTHOR]

A review of current phase III clinical trials of plaque psoriasis: under-representation of nonwhite participants and need for reform Dear Editor, Plaque psoriasis is a chronic inflammatory skin condition that affects an estimated 0-91-8-5% of the global population.1 The prevalence of psoriasis varies based on ethnoracial and geographical distribution. The search terms included "psoriasis" or "psoriasis vulgaris" or "plaque psoriasis". [Extracted from the article]

Dear Editor, Approximately 50% of patients with psoriasis are female, the majority of whom are of childbearing potential.[1] Tildrakizumab, a high-affinity, humanized, immunoglobulin (Ig)G1 , anti-interleukin-23p19 monoclonal antibody, demonstrated efficacy in treatment of moderate-to-severe chronic plaque psoriasis and was well tolerated in clinical studies.[[2]] IgG antibodies are actively transported across the placental barrier via placental Fc receptors, beginning at approximately gestational week 13.[4] The plasma half-life of tildrakizumab after subcutaneous administration is approximately 25 days;[5] therefore, tildrakizumab administered even in the first trimester may cross the placental barrier. The longest duration was for a patient whose last dose was on day 1196; this patient's full dose history was not reported (Table). These data are consistent with preclinical studies in pregnant cynomolgus monkeys, in which tildrakizumab showed no treatment-related adverse outcomes even at fetal serum concentrations many times higher than the week 16 steady-state serum concentrations observed in humans following treatment with tildrakizumab 100 mg, which ranged from 1-22 ± 0-94 g mL SP -1 sp to 1-47 ± 1-12 g mL SP -1 sp .[6] The present study adds to the existing evidence on the outcomes of biologic treatment of psoriasis during pregnancy. [Extracted from the article]

Psoriasis can be a socially isolating disease due to debilitating physical symptoms and the stigma patients feel because of the appearance of their skin. Mental health comorbidities such as anxiety, depression and suicidal ideation and behaviour ( SIB) are prevalent in patients with psoriasis. Patients with mild psoriasis can experience psychiatric comorbidities; however, disorders such as depression and SIB are more common in patients with severe psoriasis or psoriatic arthritis. Psychiatric disorders can both result from and contribute to progression of psoriasis, suggesting that psoriasis and psychiatric conditions, such as depression, may have overlapping biological mechanisms. Proinflammatory cytokines such as interleukin ( IL)-1 and IL-6 are elevated in both psoriasis and depression, indicating that the inflammatory process may be involved in the progression of both diseases. Elevated cytokine levels in the central nervous system cause physiologic and biochemical changes that may contribute to the development of depression. In this review of the literature, we discuss the evidence that supports the association of psoriasis with mental health disorders and the tools used to detect the presence of these comorbidities. Additionally, we review the most prominent hypotheses on the mechanisms by which the inflammatory response and elevated cytokines can cause depression. These results highlight the role that systemic inflammation plays in the various mental health comorbidities associated with psoriasis, including depression and SIB. [ABSTRACT FROM AUTHOR]

Background:It is well known that psoriasis significantly impacts patients’ quality of life (QoL). With the introduction of improved treatment modalities with biologic agents, more patients with moderate to severe psoriasis are able to achieve better results as measured by the Psoriasis Area and Severity Index (PASI). PASI 75 indicates a 75% or greater reduction in PASI scores from baseline and is indicative of excellent disease improvement. With newer biologic agents such as secukinumab, ixekizumab and brodalumab, patients are now capable of achieving PASI 90, introducing additional clinical decisions for physicians when considering treatment options. However, little is known regarding how the difference between achieving PASI-75 versus PASI-90 impacts patients’ QoL. Objectives:The purpose of this study was to compare how achieving PASI 75 versus PASI 90 impacts QoL for patients with moderate to severe plaque psoriasis by using validated psychometric instruments that have been widely used in both dermatologic and non-dermatologic settings. Methods:Two separate open-label clinical trials were conducted to specifically assess QoL in patients with moderate to severe psoriasis on adalimumab or ustekinumab over 24 weeks. In addition to clinical assessments of psoriasis, patients completed two surveys: The Psychological General Well-Being (PGWB) Index and the Dermatology Life Quality Index (DLQI). Changes in total PGWB score and DLQI score at weeks 12 and 24 compared to baseline were compared between groups achieving PASI 75 and PASI 90. Results:There was no statistically significant difference in PGWB scores between patients achieving PASI 75 and patients achieving PASI 90 in the adalimumab treatment group (week 12p = .21, but there was at week 24p = .05). There was a statistically significant difference in DLQI between the patients achieving PASI 75 and the patients achieving PASI 90 in the adalimumab treatment group at week 24 (p = .01), but not week 12 (p = .11). There was no statistically significant difference in PGWB scores between patients achieving PASI 75 and patients achieving PASI 90 in the ustekinumab treatment group (week 12p = .11, week 24p = .35). There was no statistically significant difference in DLQI between the patients achieving PASI 75 and the patients achieving PASI 90 in the ustekinumab treatment group at week 24 (week 12p = .49, week 24p = .11). Conclusions:There has been tremendous attention surrounding newer biologic agents that can achieve PASI 90 and even PASI 100. Although the results are impressive with regard to physical improvement of psoriasis, there may not be a clinically significant difference in QoL when comparing patients who achieve PASI-75 versus PASI 90. [ABSTRACT FROM PUBLISHER]