Date: Monday, November 6, 2017
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Denosumab is a fully human monoclonal antibody (IgG2 subclass) that inhibits bone resorption by blocking RANKL. Phase 2 (DRIVE) and phase 3 (DESIRABLE) studies demonstrated that denosumab inhibited progression of joint destruction in Japanese patients with rheumatoid arthritis (RA). The results of subgroup analyses of DRIVE study have already been reported in ACR 2014. The subgroup analyses of DRIVE and DESIRABLE studies were undertaken to understand whether denosumab was broadly effective upon progression of the joint destruction in RA patients.
These analyses used pooled data from two randomized, multicenter, double-blind placebo control trials in RA patients treated with denosumab [60 mg every 6 months (Q6M) or 60 mg every 3 months (Q3M)] or placebo. All patients continued conventional synthetic DMARDs (including MTX) and a supplement of calcium and vitamin D throughout the study. The modified total Sharp score (mTSS), the bone erosion score (ES) and the joint space narrowing score (JSN) were assessed by the modified Sharp van der Heijde method. Subgroup analyses were conducted according to risk factors for radiographic damage.
A total of 909 patients were included (306 in placebo, 302 in Q6M and 301 in Q3M). Denosumab significantly inhibited the progression of mTSS and ES from baseline to 12 months compared to placebo, whereas denosumab didnft have an effect on JSN. The incidence of adverse events (AEs), serious AEs and AEs leading to discontinuation of study drug were similar among treatment groups. Each subgroup with a specific risk factor for radiographic damage showed consistent results for the mTSS in total group.
The same tendency was observed in ES.
Denosumab inhibited the progression of the joint destruction at 12 months in Japanese patients with RA in subgroup analyses based on pooled data of DRIVE and DESIRABLE studies. These results indicate that denosumab broadly inhibits the progression of joint destruction in RA patients with risk factors for radiographic damage.
To cite this abstract in AMA style:Tanaka Y, Takeuchi T, Soen S, Ishiguro N, Yamanaka H, Yoneda T, Tanaka S, Nitta T, Okubo N, Genant HK, van der Heijde D. Consistent Inhibition of Joint Destruction By Denosumab in Important Subgroups of Japanese Patients with Rheumatoid Arthritis: Pooled Analysis of Phase 2 and 3 Studies [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/consistent-inhibition-of-joint-destruction-by-denosumab-in-important-subgroups-of-japanese-patients-with-rheumatoid-arthritis-pooled-analysis-of-phase-2-and-3-studies/. Accessed January 23, 2020.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/consistent-inhibition-of-joint-destruction-by-denosumab-in-important-subgroups-of-japanese-patients-with-rheumatoid-arthritis-pooled-analysis-of-phase-2-and-3-studies/