Attainment of treat-to-target endpoints in SLE patients with high disease activity in the atacicept phase 2b ADDRESS II study
| Autor: | Eric F Morand, David A. Isenberg, Joan T. Merrill, Cristina Vazquez-Mateo, P Chang, Amy H. Kao, Daniel J. Wallace, Kishore Pudota, Cynthia Aranow |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
0301 basic medicine
Adult Male medicine.medical_specialty Randomization Recombinant Fusion Proteins Population SLE Placebo Atacicept Placebos 03 medical and health sciences 0302 clinical medicine remission Rheumatology Double-Blind Method Internal medicine Post-hoc analysis medicine Odds Ratio Humans Lupus Erythematosus Systemic Pharmacology (medical) education AcademicSubjects/MED00360 030203 arthritis & rheumatology education.field_of_study Surrogate endpoint business.industry Remission Induction Odds ratio Clinical Science lupus low disease activity state medicine.disease Clinical trial 030104 developmental biology low disease activity Treatment Outcome Female business treat to target atacicept |
| Zdroj: | Rheumatology (Oxford, England) |
| ISSN: | 1462-0332 1462-0324 |
| Popis: | Objective Low disease activity (LDA) and remission are emerging treat-to-target (T2T) endpoints in SLE. However, the rates at which these endpoints are met in patients with high disease activity (HDA) are unknown. Atacicept, which targets B lymphocyte stimulator and a proliferation-inducing ligand, improved disease outcomes in SLE patients with HDA (SLEDAI-2K ≥10) at baseline in the phase 2b ADDRESS II study. This is a post hoc analysis of T2T endpoints in these patients. Methods Patients received weekly atacicept (75 or 150 mg s.c.) or placebo for 24 weeks (1:1:1 randomization). Attainment of three T2T endpoints, LDA (SLEDAI-2K ≤ 2), Lupus Low Disease Activity State (LLDAS) and remission (clinical SLEDAI-2K = 0, prednisone-equivalent ≤5mg/day and Physician’s Global Assessment Results Of 306 randomized patients, 158 (51.6%) had baseline HDA. At week 24, 37 (23.4%) HDA patients attained LDA, 25 (15.8%) LLDAS and 17 (10.8%) remission. Each of these endpoints was more stringent than SRI-4 (n = 87; 55.1%) and SRI-6 (n = 67; 42.4%). Compared with placebo (n = 52), at week 24, patients treated with atacicept 150 mg (n = 51) were more likely to attain LDA [odds ratio (OR) 3.82 (95% CI: 1.44, 10.15), P = 0.007], LLDAS [OR 5.03 (95% CI: 1.32, 19.06), P = 0.018] or remission [OR 3.98 (95% CI: 0.78, 20.15), P = 0.095]. Conclusion At week 24, LDA, LLDAS and remission were more stringent than SRI-4 and SRI-6 response, were attainable in the HDA population and discriminated between treatment with atacicept 150 mg and placebo. These results suggest that T2T endpoints are robust outcome measures in SLE clinical trials and support further evaluation of atacicept in SLE. Trail registration ClinicalTrials.gov, http://clinicaltrials.gov, NCT01972568. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|