Merrill, JT;
Wallace, DJ;
Wax, S;
Kao, A;
Fraser, PA;
Chang, P;
Isenberg, D;
(2018)
Efficacy and Safety of Atacicept in Patients With Systemic Lupus Erythematosus: Results of a Twenty‐Four–Week, Multicenter, Randomized, Double‐Blind, Placebo‐Controlled, Parallel‐Arm, Phase IIb Study.
Arthritis & Rheumatology
, 70
(2)
pp. 266-276.
10.1002/art.40360.
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Efficacy and Safety of Atacicept in Patients With Systemic Lupus Erythematosus: Results of a Twenty-Four-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase IIb Study.pdf - Published Version Download (380kB) | Preview |
Abstract
OBJECTIVE: To evaluate the efficacy and safety of atacicept, an antagonist of BLyS/APRIL-mediated B cell activation, in patients with systemic lupus erythematosus (SLE). METHODS: ADDRESS II was a phase IIb, multicentre study (NCT01972568). Patients with active, autoantibody-positive SLE receiving standard therapy were randomized (1:1:1) to atacicept (75 or 150 mg) or placebo for 24 weeks. The primary endpoint was the SLE responder index (SRI)-4 at Week 24. RESULTS: The ITT population included 306 patients. There was a trend towards improved SRI-4 response rate with atacicept 75 mg (57.8% [adjusted OR 1.78], P = 0.045) and 150 mg (53.8% [adjusted OR 1.56], P = 0.121) versus placebo (44.0%) at Week 24 (primary analysis; screening visit as baseline). In a pre-specified sensitivity analysis using study Day 1 as baseline, a significantly larger proportion of patients receiving atacicept 75 mg (55.9% [adjusted OR 1.88], P = 0.029) and 150 mg (55.8% [adjusted OR 1.96], P = 0.020) achieved SRI-4 response at Week 24 versus placebo (41%). In pre-defined subpopulations with baseline high disease activity (HDA), serologically active disease (SA), or both, statistically significant improvements in SRI-4 and SRI-6 response rates were seen with atacicept versus placebo. Severe flare risk was reduced with atacicept in both the ITT and HDA populations. The risks of serious adverse events and serious or severe infection were not increased with atacicept versus placebo. CONCLUSION: Atacicept showed evidence of efficacy in SLE, particularly in HDA and SA patients. Reductions in disease activity and severe flare were observed with atacicept treatment, along with an acceptable safety profile.
| Type: | Article |
|---|---|
| Title: | Efficacy and Safety of Atacicept in Patients With Systemic Lupus Erythematosus: Results of a Twenty‐Four–Week, Multicenter, Randomized, Double‐Blind, Placebo‐Controlled, Parallel‐Arm, Phase IIb Study |
| Location: | United States |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1002/art.40360 |
| Publisher version: | http://dx.doi.org/10.1002/art.40360 |
| Language: | English |
| Additional information: | Copyright © 2017, The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Inflammation |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10033867 |
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