Assessment of an Oral Corticosteroid Withdrawal Pathway for Severe Asthma Patients Receiving Biologic Therapies

Abstract

Background: The optimal approach to weaning maintenance oral corticosteroids (mOCS) in patients with severe asthma receiving biologics remains unclear. Previous studies assessed hypothalamic-pituitary-adrenal function at 5 mg daily prednisolone, a supraphysiologic dose for many, necessitating further mOCS reduction for adrenal recovery.

Objective: We evaluated a protocol-driven, nurse-led mOCS withdrawal pathway with clinical oversight for patients with severe asthma receiving biologics.

Methods: Patients with severe asthma receiving biologics, who had reduced mOCS to 5 mg prednisolone daily and maintained good asthma control, entered the withdrawal pathway. Prednisolone was decreased to 4 mg daily for 6 weeks and then 3 mg daily for 6 weeks, followed by 09.00 serum cortisol measurement. Patients with cortisol greater than 25 nmol/L followed a 20-week weaning protocol. Serum cortisol was rechecked 12 weeks after stopping mOCS.

Results: Of 102 patients, 92 had cortisol greater than 25 nmol/L with 3 mg prednisolone and continued weaning. A total of 73 (72%) successfully discontinued mOCS with median (interquartile range) cortisol increasing from 192 (88-299) nmol/L with 3 mg prednisolone to 314 (248-437) nmol/L at 12 weeks after discontinuation (P < .0001). Twenty-nine patients (28%) paused weaning owing to adrenal insufficiency symptoms (n = 22), worse asthma control (n = 1), anxiety (n = 2), and other reasons (n = 4). The baseline cortisol in this group was 53 (25-166) nmol/L, and patients are currently well and receiving a median of 3.0 (3.0-3.9) mg prednisolone. Duration of prior oral corticosteroid use was significantly shorter in the group that was successfully weaned compared with those who failed weaning (P = 0.003). No serious adverse events occurred.

Conclusion: Most clinically stable patients with asthma receiving biologics successfully withdrew mOCS without requiring dynamic adrenal function testing.

Keywords: Adrenal insufficiency; Asthma; Cortisol; Maintenance; Oral corticosteroids; Prednisolone; Weaning.