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Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial Prof Richard A Furie, MD, Prof Eric F Morand, MBBS, Ian N Bruce, MD, Susan Manzi, MD, Kenneth C Kalunian, MD, Edward M Vital, MRCP, Theresa Lawrence Ford, MD, Ramesh Gupta, MD, Prof Falk Hiepe, MD, Mittermayer Santiago, MD, Philip Z Brohawn, MBA, Anna Berglind, PhD, Raj Tummala, MD The Lancet Rheumatology Volume 1, Issue 4, Pages e208-e219 (December 2019) DOI: /S (19) Copyright © 2019 Elsevier Ltd Terms and Conditions
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Figure 1 Trial profile *All patients from one site (three randomised patients and one patient ineligible because of screening failure) were excluded from all analyses because of non-compliance with study procedures. The Lancet Rheumatology 2019 1, e208-e219DOI: ( /S (19) ) Copyright © 2019 Elsevier Ltd Terms and Conditions
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Figure 2 Primary and selected secondary efficacy outcomes
Composite efficacy outcomes using the prespecified restricted medication rules for determining non-response: SRI-4 response (anifrolumab n=180, placebo n=184; A), CLASI response (anifrolumab n=58, placebo n=54; B), and BICLA response (anifrolumab n=180, placebo n=184; C). Analysis with amended rules for restricted medications: SRI-4 response (anifrolumab n=180, placebo n=184; D), CLASI response (anifrolumab n=58, placebo n=54; E), and BICLA response (anifrolumab n=180, placebo n=184; F). BICLA=British Isles Lupus Assessment Group-based composite lupus assessment. CLASI=cutaneous lupus erythematosus disease area and severity index. SRI-4=systemic lupus erythematosus responder index-4. The Lancet Rheumatology 2019 1, e208-e219DOI: ( /S (19) ) Copyright © 2019 Elsevier Ltd Terms and Conditions
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Figure 3 BICLA response and type I interferon gene signature suppression (A) Time to onset of BICLA response that was sustained to week 52. Patients without a BICLA response sustained up to week 52 are censored at the date of study treatment discontinuation or week 52, whichever occurred earlier. Points on graph show censored patients. (B) Median percentage of baseline type I interferon pharmacodynamic (21-gene) signature at each visit among patients with high type I interferon gene signatures (>2-fold change in interferon gene expression relative to that of healthy volunteers) at baseline. Error bars show median absolute deviation. The last dose of study medication was at week 48. BICLA=British Isles Lupus Assessment Group-based composite lupus assessment. The Lancet Rheumatology 2019 1, e208-e219DOI: ( /S (19) ) Copyright © 2019 Elsevier Ltd Terms and Conditions
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