This website is intended for healthcare professionals only.

Hospital Healthcare Europe
Hospital Pharmacy Europe     Newsletter    Login            

Press Releases

Take a look at a selection of our recent media coverage:

Clinical remission criteria for severe asthma defined by SANI group

14th August 2023

Criteria to define both complete and partial clinical remission in patients with severe asthma has been developed by the Severe Asthma Network Italy (SANI) group.

Published in the Journal of Allergy and Clinical Immunology in Practice, the SANI group set out to highlight a consensus for asthma remission using the Delphi technique.

A panel of 80 experts, which included pneumologists and allergists from the SANI network, covering 57 severe asthma centres, and more then 2,200 patients, were included in the Delphi process.

In the first Delphi round, the group created 32 statements, which were divided in four main categories: general questions about remission; criteria for clinical remission criteria; complete or partial clinical remission and its duration; and cut-off values of different scores regarding disease control, lung function and inflammation. Each of these statements used a five-point Likert scale to measure panellist’s agreement to each statement.

The statements were sent to the panellists and, following an interim analysis, the responses were discussed to produce a consistent questionnaire for the second round.

SANI group definition for clinical remission

During the second Delphi round, the criteria for complete clinical remission was confirmed as a composite of the absence for the need for oral corticosteroids (OCS); the absence of symptoms, exacerbations or attacks; and pulmonary stability. Moreover, these criteria had to be present for at least 12 months.

In contrast, partial clinical remission was defined where there was no further need for using
OCS, plus two out of the following three criteria: absence of asthma symptoms, absence of asthma
exacerbations or attacks, and pulmonary stability.

‘This SANI Delphi analysis defined a valuable, independent and easy-to-use tool to test the efficacy of different treatments in patients with severe asthma enrolled into the SANI registry,‘ the authors said.

Approximately 10-20% of people with asthma are estimated to have severe disease. The SANI group hopes that its definitions of complete and partial remission can be used to test the efficacy of different
treatments in patients enrolled and followed in the SANI registry.

Guselkumab-golimumab combination provides superior clinical remission in ulcerative colitis

17th October 2022

Guselkumab and golimumab induction therapy gave a higher rate of clinical remission in ulcerative colitis compared to monotherapy

Combining guselkumab and golimumab as an induction therapy for patients with ulcerative colitis with guselkumab as a maintenance treatment, gave rise to a higher level of clinical remission than monotherapy with either agent, according to the findings of a phase 2a, randomised, double-blind study presented at the United European Gastroenterology (UEG) week.

Inflammatory bowel disease includes both ulcerative colitis (UC) and Crohn’s disease and the prevalence of UC in Europe ranges from 0.9 to 24.3 per 100,000 person-years. UC is a chronic inflammatory condition and typically, those who are affected can experience loose and urgent bowel movements, blood stools, abdominal cramps and pains.

In recent years, the use of biological therapy with monoclonal antibodies such as guselkumab and golimumab have provided significant benefit for patients with ulcerative colitis. Guselkumab (brand name Tremfya) is an antagonist of the p19 subunit of IL-23 and approved to treat plaque psoriasis and psoriatic arthritis. In contrast, golimumab (brand name Simponi) is an antagonist of TNFa and is approved for the treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy.

The value of guselkumab in UC was examined in the QUASAR Induction Study in which enrolled patients with moderately to severely active ulcerative colitis previously unsuccessfully managed with conventional or advanced therapy that was intolerable or inadequate. Both a lower and higher dose of guselkumab were used and the results showed that clinical remission occurred in 25.7% and 25.2% of patients receiving the lower and higher dose respectively.

In the VEGA trial presented at UEG, researchers examined the safety and efficacy of combination therapy with guselkumab and golimumab. All patients were naïve to TNFa antagonists and refractory or intolerant to conventional therapy and randomised to receive intravenous guselkumab, golimumab or both agents combined as induction therapy. After 12 weeks, patients randomised to monotherapy continued their initially assigned treatment through to week 38, whereas patients given the combination switched to guselkumab maintenance therapy. Clinical remission was based on the total Mayo score, as well as the modified Mayo score components, symptomatic remission, endoscopic improvement, endoscopic normalisation, histologic remission and composite histologic-endoscopic endpoints were assessed. 

Guselkumab-golimumab and clinical remission

A total of 214 patients were randomised to one of the three treatment options although 13.1% discontinued before week 34.

Using the modified Mayo score, clinical remission occurred in 47.9% of those receiving combination induction treatment compared to 20.8% for the golimumab and 31% in the guselkumab monotherapy groups and in both cases this difference was statistically significant.

Safety events were similar between the three groups as were the rates of serious adverse events.

The authors concluded the use of combination induction therapy followed by maintenance with guselkumab experienced greater rates of clinical remission, endoscopic improvement, endoscopic normalization, and both histologic remission and endoscopic improvement