Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial

Impact of biologic therapies on risk of major adverse cardiovascular events in patients with psoriasis: systematic review and meta-analysis of randomized controlled trials

“…In all, 38 RCTs (identified in 38 reports)20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57 met the eligibility criteria and were included, as shown in Figure 1. These trials involved a total of 18 024 patients with plaque psoriasis.…”

“…Eighteen RCTs compared TNFi (four adalimumab,20, 21, 22, 23, 24 nine etanercept,26, 27, 28, 29, 30, 31, 32, 34, 35 five infliximab36, 37, 38, 39, 40) with placebo, with three studies reporting MACEs; four RCTs compared ustekinumab (anti‐IL‐12/23) with placebo46, 47, 48 with no MACEs reported. One RCT compared ixekizumab with placebo without MACEs reported 56, 57.…”

“…Patients in 27 RCTs20, 21, 22, 25, 27, 28, 29, 30, 31, 34, 35, 36, 37, 38, 39, 40, 43, 45, 46, 47, 48, 50, 52, 53, 57 did not experience MACEs while exposed to any interventions but 10 MACEs were observed during the randomized controlled phase of nine studies 23, 26, 32, 33, 42, 44, 49, 51. Overall, the pooled analysis of these nine trials found that there was no statistically significant difference in the risk of MACEs when comparing biologic therapies with placebo (pooled OR 1·45, 95% CI 0·34–6·24, P  = 0·62), as shown in Figure 2a.…”

An intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis (METOP): a 52 week, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

“…1 Laboratory: Complete blood count, Differential blood count, Serum creatinine, calculated creatinine clearance, CRP, -GT, ASAT, ALAT, AP, U-Status, USediment if necessary; 1a blood sample for baseline safety lab check (incl. bilirubin, serum albumin) will only be performed in case of more than 8 days between screening (V0) and baseline (V1) 2 For females only, at screening from serum and 2a on visit 1 from urine 3 reduced NAPSI assessment (only of worst and best finger) 4 Short questionnaire to assess status of psoriatic arthritis 5 Patient questionnaire to observe the patient's satisfaction with the pre-filled syringe 6 At each regular visit used study medication and the medication card will be collected and new study medication and updated medication card will be handed out to the patients. Any potential participant who upon entrance into the treatment phases of the study meets all of the inclusion criteria and none of the exclusion criteria set forth in the protocol and had signed a valid IRB/IEC approved informed consent form.…”

“…In 2014, the World Health Organisation recognized psoriasis as a serious non-communicable disease and its report from 2016 highlighted the life running nature of the disease and the need to urgently research and make accessible cost effective medicines throughout the world. 1 The development of monoclonal antibodies that target cytokines central to the psoriatic disease cascade including TNF, IL-23, and IL-17A, has significantly broadened the therapeutic armamentarium [2][3][4] however, recent surveys indicate restricted usage of these expensive therapies in less than 10% of patients with moderate-to-severe disease even in Western countries. 5 For over 50 year's methotrexate (MTX) has been used in the treatment of psoriasis and psoriatic arthritis and is recommended as first-line systemic agent for the treatment of moderate-to-severe psoriasis in US and European guidelines 6 mainly based on experience and health economic considerations.…”