DORIS REMISSION IN PATIENTS WITH SLE TREATED WITH ANIFROLUMAB: POST HOC ANALYSIS FROM TULIP-1 AND TULIP-2 TRIALS IN PATIENTS WITH NO PRIOR IMMUNOSUPPRESSANT USE
Bibliographic record
Abstract
PV253 / #124 Poster Topic: AS24 - SLE-Treatment Background/Purpose 2023 EULAR treatment recommendations for SLE present the option for early biologic use without prior failure of immunosuppressants/disease-modifying antirheumatic drugs (DMARDs), in patients with inadequate responses to antimalarials alone or in combination with glucocorticoids (GC).[1] There are limited data demonstrating clinical benefits with biologics in immunosuppressant-naïve patients with SLE treated with either antimalarials, oral GCs, or the combination. This post hoc analysis investigated DORIS (Definition of Remission in SLE) remission attainment in patients with moderate to severe SLE treated with intravenous anifrolumab 300 mg or placebo in the TULIP-1 ( NCT02446912 [2]) or TULIP-2 ( NCT02446899 [3]) phase 3 trials who had no reported history of prior immunosuppressant use. Methods This post hoc analysis included a subset of patients from the TULIP-1 and TULIP-2 trials who were ‘immunosuppressant-naïve,’ defined as patients with a treatment history of antimalarials or oral GCs at enrollment, or the combination of antimalarials and GCs, but without prior use of immunosuppressants or DMARDs. DORIS remission attainment was assessed for the period after randomization. DORIS remission was defined as total clinical SLEDAI-2K score (sum of all SLEDAI-2K items except increased DNA binding and low complement) = 0, Physician’s Global Assessment < 0.5, and prednisone/equivalent dosage ≤ 5 mg/day. DORIS attainment was analyzed using a stratified Cochran–Mantel–Haenszel approach. Results A total of 257 patients (anifrolumab 300 mg, n = 127; placebo, n = 130) in the pooled TULIP-1 and TULIP-2 trial dataset were immunosuppressant-naïve. Among this subgroup, 21 (16.2%) of immunosuppressant-naïve patients in the anifrolumab 300 mg group attained DORIS remission at Week 52 compared with 7 (6.0%) patients in the placebo group (treatment difference: 10.2% [95% CI: 1.3-19.1], nominal P = 0.0242). DORIS attainment rates generally increased from baseline through to Week 52 (Figure 1). Figure 1. Attainment of DORIS remission across 52 weeks in patinets with no reported history of poor immunosuppressant use. *denotes nominal P < 0.05 calculated using using a stratified Cochran-Mantel-Haenszel approach, with stratification factors of SLEDAI-2K at screening Day 1 glucocorticoid dosage, type I interferon gene signature at screening and study (TULIP-1 vs TULIP-2). Conclusions In this post hoc analysis, a higher proportion of immunosuppressant-naïve patients with moderate to severe SLE treated with anifrolumab attained DORIS remission at Week 52 compared with those who received placebo. These results are consistent with EULAR recommendations to consider initiating treatment with biologics early, before immunosuppressants. References: [1.] Fanouriakis A. Ann Rheum Dis 2019;78:736-45. [2.] Furie RA. Lancet Rheumatol 2019;1:e208-19. [3.] Morand EF. N Engl J Med 2020;382:211-21. Acknowledgments: This study was sponsored by AstraZeneca. Writing assistance was provided by Tamara Fink, PhD, of JK Associates Inc., part of Avalere Health, and funded by AstraZeneca. Presented at ACR 2024 and reused with permission of Andrea D. Arthritis Rheumatol . 2024; 76 (suppl 9). https://acrabstracts.org/abstract/doris-remission-in-patients-with-sle-treated-with-anifrolumab-posthoc-analysis-from-tulip-1-and-tulip-2-trials-in-patents-with-no-reported-history-of-prior-immunosuppressant-use/ . Accessed October 31, 2024. Permissions were requested from the original abstract as cited above.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".