Topical corticosteroid withdrawal reactions

Overview of: Medicines and Healthcare products Regulatory Agency. Topical corticosteroids: information on the risk of topical steroid withdrawal reactions. Drug Safety Update 2021;15(2):1.

Improvement of skin lesions in corticosteroid withdrawal-associated severe eczema by multicomponent traditional Chinese medicine therapy

Rationale We recently showed that multicomponent traditional Chinese medicine (TCM) therapy had steroid-sparing effects in moderate-to-severe eczema. We sought to evaluate TCM effects in severe eczema in a 7-year-old male with refractory disease and corticosteroid withdrawal syndrome. Methods Prior to referral, the patient had been treated since infancy with increasingly intensive standard of care, including high-dose topical and systemic corticosteroid and antibiotic therapy and was unable to tolerate further steroid treatment. The patient was administered a combination of oral and topical TCM for 17 months following discontinuation of his steroid regimen. His overall medical condition was assessed by SCORAD criteria and laboratory evaluations of serum IgE, absolute eosinophil count, and liver and kidney function tests. Results The patient showed rapid improvement of clinical measures of disease after starting TCM therapy, with marked improvement of sleep quality within the first week, complete resolution of itching, oozing, and erythema at 2 weeks, and a 79% and 99% decrease in his SCORAD values after one month and 3–6 months of TCM, respectively. Serum total IgE decreased by 75% (from 19,000 to 4630 (kIU/L), and absolute eosinophil counts decreased by 60% (from 1000 to 427 cells/μL) after 12 months of treatment. The patient did not require oral or topical steroids during the 17-month trial of TCM. TCM was tapered without complications. His dermatologic manifestations continued to be well-controlled 3 months after discontinuation. Conclusion This case study suggests TCM should be further evaluated in controlled clinical studies of patients with severe, refractory eczema and steroid withdrawal syndrome.

Clinical Relevance of Corticosteroid Withdrawal on Graft Histological Lesions in Low-Immunological-Risk Kidney Transplant Patients

The impact of corticosteroid withdrawal on medium-term graft histological changes in kidney transplant (KT) recipients under standard immunosuppression is uncertain. As part of an open-label, multicenter, prospective, phase IV, 24-month clinical trial (ClinicalTrials.gov, NCT02284464) in low-immunological-risk KT recipients, 105 patients were randomized, after a protocol-biopsy at 3 months, to corticosteroid continuation (CSC, n = 52) or corticosteroid withdrawal (CSW, n = 53). Both groups received tacrolimus and MMF and had another protocol-biopsy at 24 months. The acute rejection rate, including subclinical inflammation (SCI), was comparable between groups (21.2 vs. 24.5%). No patients developed dnDSA. Inflammatory and chronicity scores increased from 3 to 24 months in patients with, at baseline, no inflammation (NI) or SCI, regardless of treatment. CSW patients with SCI at 3 months had a significantly increased chronicity score at 24 months. HbA1c levels were lower in CSW patients (6.4 ± 1.2 vs. 5.7 ± 0.6%; p = 0.013) at 24 months, as was systolic blood pressure (134.2 ± 14.9 vs. 125.7 ± 15.3 mmHg; p = 0.016). Allograft function was comparable between groups and no patients died or lost their graft. An increase in chronicity scores at 2-years post-transplantation was observed in low-immunological-risk KT recipients with initial NI or SCI, but CSW may accelerate chronicity changes, especially in patients with early SCI. This strategy did, however, improve the cardiovascular profiles of patients.

Abstract 13935: Steroids Wean Failures After Heart Transplantation - Does It Lead to Mortality?

Introduction: It is estimated that approximately 90% of heart transplant (HTx) patients who are low risk can be weaned off steroids after 6 months post-transplant. However, for those 10% who fail weaning subsequent outcome is not known. There is concern that failure to wean off steroids may lead to subsequent greater morbidity/mortality. Methods: Between 2010 and 2014, 178 HTx patients at low rejection risk were initiated to be weaned off steroids after 6 months post-transplant. Our protocol includes decreasing prednisone by 1mg per month from a baseline of 5mg daily. Monthly heart biopsy or use of Allomap are used to exclude rejection during weaning. 15 patients failed the corticosteroid wean due to either rejection (n=8), abnormal echocardiogram (n=2) or severe corticosteroid withdrawal symptoms (n=5). Study endpoints include subsequent 5-year survival, freedom from cardiac allograft vasculopathy (CAV) and non-fatal major adverse cardiac events (NF-MACE); and 1-year freedom from any treated rejection (ATR), antibody-mediated rejection (AMR), acute cellular rejection (ACR). Results: The failed wean group compared to the successful wean group had a trend for lower subsequent 5-year survival. There was no significant difference between the two groups in subsequent 5-year freedom from CAV or NF-MACE. Subsequent 1 Year freedom all rejection (ATR, ACR, AMR) were significantly lower in the failed steroid wean group compared to the successfully weaned group. Conclusions: HTx patients who are deemed low risk who failed corticosteroid weaning may be at risk to develop more rejection with compromised 5-year outcome, including a possible lower survival rate. It is unclear whether the act of corticosteroid weaning activated a deleterious response in these patients. Caution must be given to those patients who fail corticosteroid weaning.