Prevention of Cardiovascular and Other Systemic Adverse Outcomes in Patients with Asthma Treated with Biologics.

Journal: American Journal Of Respiratory And Critical Care Medicine

Published: May 18, 2025

Abstract

Background: Although clinical trials have documented the oral corticosteroid (OCS)-sparing effect of biologics in patients with severe asthma, little is known about whether this translates to a reduction of new-onset OCS-related adverse outcomes.

Objective: To compare the risk of developing new-onset OCS-related adverse outcomes between biologic-initiators and non-initiators.

Methods: This was a longitudinal cohort study using pooled data from the International Severe Asthma Registry (ISAR; 16 countries) and the Optimum Patient Care Research database (OPCRD; UK). For biologic-initiators, the index date was the date of biologic-initiation. For non-initiators, it was the date of enrolment (for ISAR) or a random medical appointment date (for OPCRD). Inverse-probability-of-treatment-weighting was used to improve comparability between groups and weighted Cox proportional hazard models were used to estimate the hazard ratios (HR) of developing OCS-related adverse outcomes for up to five years from the index date.

Results: 42,908 patients were included. Overall, 27.3% and 4.7% of biologic-initiators and non-initiators were long-term OCS users (daily intake ≥90 consecutive days in year pre-index), with a mean prednisolone-equivalent daily dose of 10.2 mg and 6.2 mg, respectively. Compared to non-initiators, biologic-initiators had decreased rate of developing any OCS-related adverse outcome (HR [95% CI]: 0.82 [0.72-0.93]; p=0.002), primarily driven by reduced rate of developing diabetes (0.62 [0.45-0.87]; p=0.006]), major cardiovascular events (0.65 [0.44-0.97]; p=0.034), and anxiety/depression (0.68 [0.55-0.85]; p=0.001]). There were no significant differences in the rates of new-onset cataract (HR: 0.77 [95% CI: 0.47-1.25]), sleep apnea (HR: 0.82 [95% CI: 0.78-1.41]), or other OCS-related AOs assessed (e.g. osteoporosis). The results were consistent across both datasets.

Conclusions: Our findings highlight the role for biologics in preventing new-onset OCS-related adverse outcomes in patients with severe asthma.

Authors

Mohsen Sadatsafavi, Trung Tran, Ghislaine Scelo, Ming-ju Tsai, John Busby, Benjamin Emmanuel, Liam Heaney, Christine Jenkins, Flavia Hoyte, Giorgio Canonica, Rohit Katial, Enrico Heffler, Eileen Wang, Francesca Puggioni, Michael Wechsler, Ledit R Ardusso, Jorge Máspero, Martin Sivori, Cathy Emmas, Andrew Menzies Gow, Neda Stjepanovic, Sinthia Bosnic Anticevich, Belinda Cochrane, Eve Denton, Peter Gibson, Mark Hew, Peter Middleton, Matthew Peters, Guy Brusselle, Renaud Louis, Florence Schleich, George Christoff, Todor Popov, Celine Bergeron, Mohit Bhutani, Kenneth Chapman, Andréanne Côté, Simon Couillard, Delbert Dorscheid, Libardo Jiménez Maldonado, Ivan Solarte, Carlos Torres Duque, Susanne Hansen, Celeste Porsbjerg, Charlotte Ulrik, Alan Altraja, Arnaud Bourdin, Konstantinos Exarchos, Athena Gogali, Konstantinos Kostikas, Michael Makris, Andriana Papaioannou, Patrick Mitchell, Takashi Iwanaga, Tatsuya Nagano, Yuji Tohda, Mona Al Ahmad, Désirée Larenas Linnemann, Bernt Aarli, Piotr Kuna, Cláudia Chaves Loureiro, Riyad Al Lehebi, Adeeb Bulkhi, Wenjia Chen, Yah Juang, Mariko Koh, Anqi Liu, Chin Rhee, Borja Cosio, Luis Perez De Llano, Diahn-warng Perng, Chau-chyun Sheu, Hao-chien Wang, Bassam Mahboub, Laila Salameh, David Jackson, Pujan Patel, Paul Pfeffer, Njira Lugogo, Roy Pleasants, Aaron Beastall, Lakmini Bulathsinhala, Victoria Carter, Nevaashni Eleangovan, Kirsty Fletton, John Townend, Ruth Murray, David Price

Relevant Conditions

Cataract, Asthma, Osteoporosis

Prevention of Cardiovascular and Other Systemic Adverse Outcomes in Patients with Asthma Treated with Biologics.

Similar Publications