Dupilumab treatment improves spontaneous chronic urticaria activity and quality of life

2nd March 2023

Dupilumab treatment in patients with chronic spontaneous urticaria for 24 weeks improves urticaria activity and quality of life

In an abstract presented at the American Academy of Allergy Asthma and Immunology (AAAAI) 2023 in San Antonio, US and published as a supplement in the Journal of Clinical Allergy and Immunology, dupilumab treatment for 24 weeks, in patients with chronic spontaneous urticaria, already taking H1-antihistamines, led to significant reductions in urticarial activity and improvements in quality of life.

Chronic spontaneous urticaria is an endogenous disorder that is strongly associated with autoimmunity, particularly with immunoglobulin G antibody to the alpha subunit of the IgE receptor. The term ‘chronic urticaria’ relates to urticaria lasting for more than six weeks and has two forms: chronic inducible urticaria and chronic spontaneous urticaria, with the latter giving rise to symptoms independent of an exogenous stimulus. Treatment guidelines published in 2022 recommend the use of second-generation H1-anti-histamines, at a dose of up to four times the usual dose. However, in 2019, a case report described use of dupilumab treatment at an initial dose of 600 mg then 300 mg every two weeks in a patient with therapy resistant chronic spontaneous urticaria. Within three months, the patient’s urticaria duration and severity resolved. Furthermore, in 2022, a randomised, placebo-controlled, phase 3 trial, of dupilumab treatment as an ‘add-on’ to therapy with either standard of < 4-fold antihistamine dosing or matching placebo, showed that after 24 weeks, the least squares mean change in the itch severity score over 7 days and the urticaria activity score over 7 days (UAS7) were both significantly reduced in those given dupilumab treatment.

Dupilumab treatment and urticarial activity

Data presented at the AAAI conference relates to the impact of dupilumab on urticarial activity score over 7 days (UAS7) and quality of life based on the dermatology quality of life index (DLQI). Patients taking an H1-antihistamine (up to fourfold approved dose) were randomised to add-on dupilumab 300 mg (or 200 mg for body weights < 60 kg but > 30 kg) or matching placebo every 2 weeks for 24 weeks.

The results showed that dupilumab treatment produced a significant improvement in the UAS7 score at week 24 (p = 0.0003) as well an improvement in the DLQI (p = 0.0026) compared to placebo.

Citation
Maurer M et al. Dupilumab Improves Urticaria Activity And Quality Of Life In Patients With Chronic Spontaneous Urticaria (CSU). J Allergy Clin Immunol 2023

Gas-related intestinal symptoms are associated with psychological distress and poorer quality of life

4th October 2021

Study presented at UEG Week Virtual 2021 looked at prevalence of gas-related intestinal symptoms in adults, and their association with psychological distress and a poorer quality of life.

Gas-related symptoms are associated with poorer quality of life, and higher stress, anxiety, and depression, with breaking wind being the most frequently reported gas issue, affecting eight out of 10 adults in the general population (81.3%) in a 24-hour period.
 
Other gas-related symptoms included stomach rumbling, which affected 60.5% of respondents, closely followed by belching (58%), and bad breath (48.1%). Trapped wind (47.2%), abdominal distension (39.6%) and bloating/abdominal pressure (38.5%) also had a noticeable impact, while only 11.1% of respondents reported having no gas symptoms. On average, survey participants had been affected by three different gas symptoms within the previous 24-hour period. 
 
The findings from the study, which surveyed nearly 6000 people across the United States, UK, and Mexico, were based on a representative sample of people aged 18 to 99 years asked to fill out validated Intestinal Gas Questionnaires (IGQs) via the internet, to measure the presence and severity of 7 gas-related symptoms in the last 24 hours. Researchers also collected information on body mass index, exercise, emotional wellbeing, and quality of life in the past 7 days.
 
The survey, conducted by scientists from the Rome Foundation Research Institute in the US in collaboration with Danone Nutricia Research in France, revealed that higher IGQ scores correlated with lower mental health and quality of life scores on the PROMIS Global-10 questionnaire, higher stress, anxiety, and depression, and more non-gastrointestinal (GI) symptoms. However, IGC scores did not correlate with weight/BMI and only had a modest negative association with the amount of exercise taken.
 
Younger people aged 18 to 34 and 35 to 49 had the highest overall burden of gas-related symptoms, with IGQ total scores of 24 and 22.6 respectively, compared to 12.7 in people aged 50 to 64 and 8.6 in the over 65s. People in Mexico had higher scores for all seven gas symptoms in IGQ questionnaires, and a higher average IGQ total score, of 26 compared to 14.5 in the US and 13.7 in the UK.
 
Lead author, Professor Olafur Palsson from the University of North Carolina Department of Medicine, said: “I think the most remarkable and surprising finding in our study is that almost all adults in the general population experience some daily gas-related symptoms. This is important given the data also clearly reveals that these symptoms affect people’s general wellbeing. Having a high amount of these common intestinal symptoms is associated with higher levels of depression, anxiety and stress, as well as impaired general quality of life.”
 
He added, “The reasons for the marked differences in the amount of gas-related symptoms between Mexico and the other countries we surveyed are unknown, and need to be investigated further. Cultural, linguistic, diet or public health factors might affect population levels of gas-related symptoms.”
 
The survey methods used included the IGQ, the Patient Health Questionnaire non-GI physical symptoms (PHQ-12) and anxiety and depression (PHQ-4) scales, the PROMIS Global-10 QoL questionnaire and questions on exercises amount, height, weight, and life stress.

Study assessed nurse-led palliative care intervention on patients’ quality of life

27th September 2021

A randomised trial of an oncology nurse-led palliative care intervention did not improve patient-reported outcomes at 3 months.

In patients with advanced cancer, there is a considerable impairment of most aspects of their quality of life. A holistic approach to cancer care should pay some attention to a patient’s emotional needs since many of those with cancer experience depression or anxiety as a central symptom. However, research suggests that the proportion of physician-patient consultations devoted to quality of life issues is limited although a nurse-led palliative care intervention has been shown to lead to improvements in patient’s quality of life.

To further strengthen the evidence base for the value of a nurse-led palliative care intervention, a team from the Palliative Research Centre, University of Pittsburgh, US, developed the Care Management by Oncology Nurses to Address Supportive Care Needs (CONNECT) intervention. While the pilot study found a high level of satisfaction with the intervention, it lacked a control arm and this led the team decided to examine the impact of the CONNECT intervention compared with standard oncology care among patients with advanced cancers. For the purposes of the study, patients with advanced, metastatic solid tumours were defined as those for whom the oncologist agreed with the statement “would not be surprised if the patient died next year”.

Enrolled patients were randomised to the CONNECT intervention or usual oncology care, which was defined as best practice oncology care. Patients randomised to the CONNECT arm received a monthly visit from a trained oncology nurse for a period of three months and the intervention itself was based on the chronic care model. Three primary outcome measures were used and designed to assess quality of life used and completed at baseline and after three months. The first was the Functional Assessment of Chronic illness therapy-palliative care (FACIT-Pal), where higher scores indicate better quality of life. The second assessed symptom burden with the Edmonton Symptom Assessment Scale (ESAS), for which higher scores reflect a greater symptom burden. The final measure was the Hospital Anxiety and Depression scale (HADS) where again, higher scores indicated greater levels of anxiety and depression.

Findings
A total of 672 patients with a mean age of 69.3 years (53.6% female) were enrolled and randomised to the palliative care intervention, CONNECT (336) or standard care. The two most common cancers were lung (36%) and gastrointestinal (19.5%). Among CONNECT patients, the mean number of completed visits was 2.2 and 56% of patients received 3 visits. With respect to the 3-month changes in the three outcome measures, there were no significant differences. For example, the mean FACIT-Pal scores were 130.7 and 134.1 (CONNECT vs standard care, adjusted mean difference = 1.20, p = 0.55). Similarly, there were no differences in the ESAS (adjusted mean difference = -.2.46, p = 0.11) or HADS scores.

The authors concluded that further work is required to identify effective palliative care interventions for those with advanced cancer.

Citation
Schenker Y et al. Effect of an Oncology Nurse–Led Primary Palliative Care Intervention on Patients with Advanced Cancer. The CONNECT Cluster Randomized Clinical Trial. JAMA Int Med 2021