Non-randomized (moderate): Randomization not used or not reported

No control group (high): Single-arm or uncontrolled design

Critical risk of bias (high): Overall bias rated critical

No power calculation reported (low): No power calculation reported

Serial mixed-meal tolerance testing and the authors' narrative suggested preserved beta-cell function during follow-up. Because the report covers one patient without a comparator, the signal is supportive but very uncertain.

HbA1c values remained fairly low across follow-up points, including 6.3% at 6 months and 5.4% at 30 months. In a single case, this suggests good metabolic control but cannot establish treatment efficacy.

The patient's basal insulin needs remained relatively low for much of follow-up, including 0.08 units/kg/day after the second course and 0.23 to 0.24 units/kg/day later. This may reflect partial remission, but the evidence is limited to one person.

The patient developed clinically significant cytokine release syndrome during both teplizumab courses. This indicates a clear treatment-related adverse effect in this case, although frequency cannot be estimated from a single report.

Anti-CD3 monoclonal antibody therapy given in two 12-day courses for new-onset type 1 diabetes.

Short glucocorticoid treatment was followed by improvement in cytokine release syndrome symptoms and allowed both teplizumab courses to be completed. Because there is no comparator, this should be interpreted as a cautious clinical observation rather than proof of benefit.

The authors suggest that short-term glucocorticoid use did not obviously prevent a favorable longer-term course. However, one case cannot show whether steroids truly preserved, reduced, or had no effect on teplizumab benefit.

Brief treatment with intravenous methylprednisolone and oral prednisone to manage teplizumab-related cytokine release syndrome.

Positive: 4; Negative: 1; No effect: 1; Mixed: 0

Direction counts recalculated from intervention outcomes due to mismatch with AI-provided counts.

Extracted 6 outcome signals across the study

The case suggests symptom control and treatment completion with glucocorticoids, but the evidence is uncontrolled and too limited to draw reliable conclusions.

Direction counts were recalculated from extracted outcomes because the AI-provided totals did not match.

Cytokine release syndrome symptoms ↓ after short glucocorticoid treatment

Mostly intermediate or surrogate outcomes

Intravenous methylprednisolone and oral prednisone were used during the first CRS episode, and prednisone was used again during the second course.

The patient completed both 12-day teplizumab courses without interruption after glucocorticoid treatment.

Reported HbA1c values were 6.3% at 6 months, 6.4% at 15 months, 6.1% at 24 months, and 5.4% at 30 months.

The authors reported ongoing low-dose basal insulin use and preserved mixed-meal C-peptide trends, which they interpreted as sustained partial remission.

Khine A, Sanda S, Torok C, Quandt Z, Gitelman SE. Glucocorticoids to Manage Cytokine Release Syndrome During Teplizumab Therapy for New-Onset Type 1 Diabetes. Diabetes Care. 2026;49(3):e46-e48. doi:10.2337/dc25-2494

There was no direct control comparison for steroid use during CRS management.

The patient was excluded from the parent trial analysis because glucocorticoids were prohibited.

The report cannot show whether the same outcome would happen in other patients.

In one adolescent with new-onset type 1 diabetes, short courses of glucocorticoids appeared to control teplizumab-related cytokine release syndrome and allowed both teplizumab courses to be completed.

Teplizumab treatment completion ↑ because both infusion courses were finished

HbA1c ↔ remained fairly low through follow-up in this one patient

Total daily insulin dose ↓ stayed relatively modest during partial remission

The ADA Standards of Care provide broad guidance for type 1 diabetes diagnosis, insulin treatment, and monitoring. They help place this case within current mainstream diabetes management, even though teplizumab-specific CRS management is not the main focus.

This review explains teplizumab's role in type 1 diabetes, its expected benefits, and its adverse-effect profile, including cytokine release syndrome. It provides essential context for understanding why the current case is clinically important.

Teplizumab: a disease-modifying therapy for type 1 diabetes that preserves β-cell function

This was the parent phase 3 trial context for teplizumab in new-onset type 1 diabetes. It provides the main benchmark for how beta-cell preservation is usually assessed and why this patient's exclusion from the trial analysis matters.

Teplizumab and β-cell function in newly diagnosed type 1 diabetes

This pediatric case report describes another teplizumab-related cytokine release syndrome presentation and offers a close clinical comparison. It supports the need for practical CRS management strategies during teplizumab treatment.

An atypical presentation of cytokine release syndrome with signs of arthritis during treatment with teplizumab in a pediatric patient

High risk of bias (high): Overall bias rated critical

No control group (high): No parallel control group reported

Limited population scope (moderate): Narrow population scope

Short steroid treatment may help manage teplizumab CRS without stopping therapy

This paper describes one teenager with new-onset type 1 diabetes who developed cytokine release syndrome during two teplizumab treatment courses. Short steroid treatment appeared to control the reaction, and she completed therapy with ongoing partial remission over the next 30 months, but this was only a single-patient report.

This paper mainly addresses adverse-event management, not a definitive test of teplizumab efficacy. The apparent benefit of glucocorticoids was limited to allowing treatment completion and symptom control in one patient. Because there was no formal comparison and many later outcomes reflect the broader effect of teplizumab itself, the case should be viewed as hypothesis-generating rather than practice-changing.

Steroid treatment for cytokine release syndrome during teplizumab therapy in one adolescent with new-onset type 1 diabetes

These findings apply most directly to adolescents or young people with new-onset type 1 diabetes receiving teplizumab who develop clinically significant cytokine release syndrome during treatment. Even then, the report reflects only one patient managed at a single center.

Short steroid treatment may help manage teplizumab CRS without stopping therapy

American Diabetes Association

Summary

Study Design

Interventions

Study Type

Outcomes

Duration and Size

Study Population

Age Range

Sex

Geography

Other Criteria

Comparison with other Studies

Journal Reference

Stay informed. Stay ahead.