PT  - JOURNAL ARTICLE
AU  - Damjanov, Nemanja
AU  - Tlustochowicz, Malgorzata
AU  - Aelion, Jacob
AU  - Greenwald, Maria
AU  - Diehl, Annette
AU  - Bhattacharya, Indranil
AU  - Peeva, Elena
AU  - Menon, Sandeep
AU  - Gourley, Ian
TI  - Safety and Efficacy of SBI-087, a Subcutaneous Agent for B Cell Depletion, in Patients with Active Rheumatoid Arthritis: Results from a Phase II Randomized, Double-blind, Placebo-controlled Study
AID  - 10.3899/jrheum.160146
DP  - 2016 Dec 01
TA  - The Journal of Rheumatology
PG  - 2094--2100
VI  - 43
IP  - 12
4099  - http://www.jrheum.org/content/43/12/2094.short
4100  - http://www.jrheum.org/content/43/12/2094.full
SO  - J Rheumatol2016 Dec 01; 43
AB  - Objective. To evaluate subcutaneous SBI-087 to treat rheumatoid arthritis (RA).Methods. A total of 210 adult patients with active RA were randomized to receive either 200 mg SBI-087 or placebo (Pbo), according to one of these patterns: SBI/Pbo/Pbo (SBI on Day 1), SBI/SBI/Pbo (SBI days 1 and 15), SBI/Pbo/SBI (SBI days 1 and 84), SBI/SBI/SBI (SBI days 1, 15, and 84), or Pbo/Pbo/Pbo (Pbo all 3 days). All patients were seropositive and taking background methotrexate. The primary endpoint was proportion of patients achieving 20% improvement from baseline at Week 16 by American College of Rheumatology criteria (ACR20). Other outcomes included 28-joint Disease Activity Score (DAS28)–C-reactive protein (CRP), physician’s and patient’s global assessments of disease activity (PGA and PtGA, respectively) and Health Assessment Questionnaire–Disability Index (HAQ-DI). Peripheral CD19+ B cells were measured by high-sensitivity flow cytometer. Statistical significance was set at 2-sided α 0.10 level.Results. The SBI/SBI/SBI group demonstrated significant improvement in ACR20 and DAS28-CRP from Week 8 onward, sustained improvement in CRP levels from Week 12 onward, and significant improvements in PGA and PtGA in weeks 16 through 24, and in HAQ-DI at Week 24. The SBI/Pbo/Pbo and SBI/SBI/Pbo groups did not meet the primary endpoint but demonstrated improvements in several secondary endpoints. All treatment groups exhibited depletion of peripheral CD19+ B cells throughout the study. Overall, 61.5% of patients receiving SBI-087 and 55.0% of patients receiving Pbo reported adverse events.Conclusion. SBI-087 effectively depleted peripheral CD20 B cells and was well tolerated. Improvements were consistently observed in the SBI/SBI/SBI group for the majority of efficacy and quality-of-life outcomes.