Background Chronic spontaneous urticaria (CSU) is defined as spontaneous occurrence of wheals and/or angioedema for ≥6 weeks. Omalizumab is a monoclonal anti-IgE antibody effective in refractory CSU, but its mechanism of action and markers predictive of response remain not completely defined.Objectives To correlate baseline levels of two proposed biomarkers, total IgE (bIgE) and D-dimer (bD-dimer), and clinical parameters to omalizumab response and to relapses after drug withdrawal.Methods In this retrospective Italian multicentre study, clinical data were collected in 470 CSU patients, and bIgE and bDdimer were measured in 340 and 342 patients, respectively. Disease activity was determined by Urticaria Activity Score 7 (UAS7) at week 1 and 12 after omalizumab starting. Relapses were evaluated during a 2-and 3-month interval after a first and a second course of treatment, respectively.Results bIgE correlated to a good response to omalizumab since levels were significantly higher in responders than nonresponders (P = 0.0002). Conversely, bD-dimer did not correlate to response. There was no correlation between both bIgE and D-dimer and either first or second relapse. Disease duration was significantly longer in patients who experienced either first or second relapse (P < 0.0001 and P = 0.0105, respectively), while baseline UAS7 correlated only to first relapse (P = 0.0023).Conclusions Our study confirms bIgE as a reliable biomarker predicting response to omalizumab in CSU, while it does not support the usefulness of bD-dimer unlike previous findings. CSU duration before omalizumab and baseline UAS7 may be clinical markers of relapse risk. JEADV 2019, 33, 918-924 Predictors of response to omalizumab and relapse in CSU Positivity for antithyroglobulin or antithyroperoxidase autoantibodies §, n (%) 106 (26.7) 15 (36.6) 0.1995 †IgE values missing for 130 patients. ‡D-dimer values missing for 128 patients. §Data missing for 32 patients. IQR: interquartile range; SD: standard deviation.
In psoriasis patients, satisfaction and patients' attitude toward treatment are heterogeneous depending on several factors and remain poorly investigated, although the availability of several new targeted therapeutic options. A multicentre cross‐sectional investigation was conducted to estimate treatment satisfaction and attitudes (awareness, trust, and therapeutic alliance) in a large population of adult psoriasis patients undergoing a systemic biologic or non‐biologic agent for moderate‐to‐severe plaque‐type psoriasis. Patients' satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication II questionnaire and patients' attitudes toward treatment were evaluated using a Lickert scale. Results were related to patients' and treatment characteristics and therapeutic outcomes. The study included 899 psoriasis patients and demonstrated high‐treatment satisfaction and positive attitudes toward systemic treatments, with greater influence of the perceived efficacy and the type of treatment. Biologic treatments and, in particular anti‐IL17 agents showed higher results. More efforts in developing tools facilitating communication and exploring important aspects of patients' view are needed.
Summary Background Secukinumab is administered at the labelled dose of 300 mg at weeks 0, 1, 2, 3, 4 (loading dose) and every 4 weeks thereafter. Objectives To investigate the efficacy of secukinumab administered without the initial loading dose in patients with psoriasis. Methods This was a retrospective observational study including adult patients with psoriasis (n = 156) treated with secukinumab 300 mg administered either according to the labelled dose (n = 75) or without the initial loading dose (n = 81). Efficacy was evaluated by comparing the Psoriasis Area and Severity Index (PASI) 75 and PASI 90 response rates at week 8, 12, 16, 32 and 48. Results For patients who received the labelled dose vs. those who did not, PASI 75 response rates were achieved at week 8, 12, 16, 32 and 48 by 60% vs. 40% (P < 0·01), 72% vs. 61% (P < 0·01), 77% vs. 75%, 85% vs. 77% and 79% vs. 78%, respectively. PASI 90 responses were achieved at the same time points by 45% vs. 31% (P < 0·01), 49% vs. 40% (P < 0·01), 54% vs. 47%, 55% vs. 47% and 57% vs. 54% for those who received the labelled dose vs. those who did not, respectively. A greater proportion of patients receiving secukinumab without the loading dose discontinued treatment because of inefficacy (25% vs. 13%, P < 0·05), particularly those with body weight greater than 80 kg. Conclusions Secukinumab administered without the loading dose is associated with a higher proportion of primary inefficacy, and achieved inferior results compared with the labelled dose at week 8 and week 12, but showed similar efficacy thereafter. What's already known about this topic? Secukinumab is an interleukin (IL)‐17A inhibitor for chronic plaque psoriasis administered by subcutaneous injections at the labelled dose of 300 mg at weeks 0, 1, 2, 3, 4 (loading dose) and every 4 weeks thereafter (maintenance dose). Dose adjustment is common in clinical practice, and can consist of dose reduction when a prolonged remission is obtained or a dose increase in order to improve efficacy. What does this study add? The efficacy of secukinumab administered without the initial weekly loading dose was significantly inferior compared with the labelled dose in the short term, but was similar after week 16 and up to week 48. A greater proportion of patients receiving secukinumab without the loading dose showed primary inefficacy, particularly those with body weight greater than 80 kg.
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