Article Text

Download PDFPDF

Correction: Lupus low disease activity state attainment in the phase 3 TULIP trials of anifrolumab in active systemic lupus erythematosus

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Morand EF, Abreu G, Furie RA, et al. Lupus low disease activity state attainment in the phase 3 TULIP trials of anifrolumab in active systemic lupus erythematosus. Annals of the Rheumatic Diseases 2023;82:639-645.

This note aims to correct an error in the DORIS (Definition of Remission in SLE) data in the Morand E, et al. (2023) article. In the version of this article initially published, analyses of DORIS remission excluded all laboratory parameters in the calculation of clinical SLEDAI-2K (cSLEDAI-2K), consistent with the cSLEDAI-2K definition in the TULIP protocols. The updated analysis aligns with the published DORIS remission definition by excluding only the serologic laboratory parameters from cSLEDAI-2K. These updates do not change the conclusions of the findings and this correction aligns the analysis with the validated DORIS remission definition that is now promulgated in the 2023 EULAR SLE treatment guidelines. Changes are summarised below:

The corrected definition of DORIS in the Methods is: ‘DORIS remission was defined as all of the following: clinical SLEDAI-2K (sum of all SLEDAI-2K items except increased DNA binding and low complement) =0, PGA<0.5, prednisone or equivalent dosage≤5 mg/day, and stable doses of immunosuppressants; antimalarials were permitted.’ DORIS attainment was assigned only if patients had no breach of concomitant medication rules and had not discontinued investigational product.

DORIS data in the Abstract, Results, and Discussion are affected. At Week 52, 15.3% (55/360) of anifrolumab-treated patients attained DORIS remission (this value remained unchanged with the new analysis) compared with 6.6% (24/366) in the placebo group (this value was 7.6% in the original published version) (odds ratio [95% confidence interval]: 2.6 [1.6–4.3], nominal p=0.0002).

Figure 5 and the legend have been updated to reflect the new analyses:

Embedded Image

Figure 5 Attainment of DORIS remission across 52 weeks. Remission attainment from weeks 0 to 52 in patients treated with intravenous anifrolumab 300 mg or placebo every 4 weeks. Responder rates (percentages) were weighted and calculated using a stratified Cochran-Mantel-Haenszel approach, with stratification factors SLEDAI-2K score at screening, Day one glucocorticoid dose, type I IFN gene signature test result at screening. Nominal p values were calculated using logistic regression with the same stratification factors. **p<0.01; ***p<0.001. DORIS, Definition of Remission in Systemiclupus erythematosus; IFN, interferon; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000.

Finally, the publication cited in the Results and Discussion relating to the DORIS data (reference 26, Van Vollenhoven R, et al (abstract). Arthritis Rheumatology 2022;74) should be disregarded because it reported the initial DORIS analyses which excluded all laboratory parameters; therefore, values differ from the updated analyses.

Linked Articles