MADRID — A specific glucocorticoid dose tapering schedule in individuals with rheumatoid arthritis (RA) taking tocilizumab has been shown to be safe, according to research presented at the 2019 European League Against Rheumatism Congress, held June 12-15, in Madrid, Spain.

This study included individuals with RA who were either in remission or had low disease activity for at least 4 weeks. All participants were treated with daily prednisone 5 mg and tocilizumab, and some were also taking conventional synthetic disease-modifying antirheumatic drugs (csDMARDs).

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To be eligible, participants had to have at least 6 prior months of tocilizumab and glucocorticoid use. Participants were randomly assigned a prednisone taper (n=131; 1 mg decreases per 4 weeks) or daily prednisone 5mg (n=128), both of which were double-blind. All participants remained on stable tocilizumab and csDMARDs for 24 weeks. Prednisone 5mg/day was administered to treat flares.

The primary end point of the study was to maintain disease control after discontinuing glucocorticoids. The study protocol included guidelines for managing and diagnosing adrenal insufficiency.


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By week 24, 65% of all participants achieved treatment success on prednisone taper. Treatment success was defined as lack of disease flares, no adrenal insufficiency, and maintenance of low disease activity. Among those who continued on prednisone, 77% achieved treatment success, yielding a risk ratio of 0.833 (95% CI, 0.714-0.972; P =.021). Adrenocorticotropic hormone testing was not required in any participants undergoing a prednisone taper, nor was adrenal insufficiency found.

Researchers concluded that this study “demonstrated the usefulness of a new standardized [glucocorticoid] dose taper scheme. Two-thirds of patients receiving [tocilizumab] underwent successful tapering and could stop [glucocorticoids] entirely, which is higher than the spontaneous 35% discontinuation rate observed in real-world RA patients and underscores the potential to further reduce glucocorticoid burden. Clinical [adrenal insufficiency] was not observed; thus, routine laboratory testing may be unnecessary in real-world applications of this taper scheme.”

Disclosure: This study was funded by Roche. Multiple authors disclosed affiliations with pharmaceutical companies. See the reference for complete disclosure information.

Reference

Buttgereit F, Michael Nebesky J, Burmester GR, et al. Glucocorticoid tapering in monthly 1-mg decrements does not result in clinically manifest adrenal insufficiency in patients with rheumatoid arthritis: learnings from the phase 3/4 semira study. Presented at: European League Against Rheumatism (EULAR) Congress 2019; June 12-15, 2019; Madrid, Spain. Abstract THU0128.