Background In Phase 3 studies, baricitinib (bari) treatment with 2 different doses (2 mg and 4 mg once daily) demonstrated significant improvements across multiple measures of disease activity in patients (pts) with active RA and an inadequate response (IR) to conventional synthetic (cs) DMARDs (RA-BUILD¹) or biologic (b) DMARDs (RA-BEACON²).

Objectives To determine the effect of starting dose of bari on achieving and sustaining low disease activity (LDA).

Methods RA-BUILD and RA-BEACON trials were 24 week (wk), placebo (PBO) controlled studies. Pts completing the studies on bari treatment could enter a long-term extension (LTE) study, RA-BEYOND, continuing blinded treatment with the same dose, while pts on PBO switched to bari 4 mg. This post hoc analysis assessed disease activity in pts who achieved CDAI ≤10 at ≥1 visit (LDA) or at ≥2 consecutive visits (sustained LDA) within the originating study (24 wks) and continued into the LTE. The length of time required by pts to achieve LDA was determined by the incidence rate (percent pts responding per month) for each group.

Results Treatment with bari 2 mg and 4 mg, when compared to PBO, resulted in higher rates of LDA and sustained LDA, as well as higher incidence rates (shorter time to achieve LDA/sustained LDA) within 24 wks of each originating study. Across studies, treatment with bari 4 mg demonstrated higher incidence rates when compared to bari 2 mg, both in achieving LDA and sustained LDA, indicating that these pts reached the desired LDA state faster. Incidence rates were lower in all treatment groups in bDMARD-IR pts compared with csDMARD-IR pts.

Conclusions The most robust benefit in terms of achieving LDA and sustained LDA was observed with bari 4 mg treatment, which required shorter time to response, than treatment with 2 mg. This was observed in both the short (24 wks) and in the long-term in pts with IR to csDMARDs or bDMARDs.

References

1. Dougados M et al. Ann Rheum Dis 2017; 76(1):88–95.

2. Genovese M et al. N Engl J Med 2016; 374(13):1243–52.

References

Disclosure of Interest J. Curtis Grant/research support from: Abbvie, Amgen, BMS, Corrona, Eli Lilly and Company, Janssen, Myriad, Pfizer, Roche/Genentech, UCB, Consultant for: Abbvie, Amgen, BMS, Corrona, Eli Lilly and Company, Janssen, Myriad, Pfizer, Roche/Genentech, UCB, A. Kavanaugh Consultant for: Eli Lilly and Company, D. van der Heijde Consultant for: Abbvie, Amgen, Astellas, Astra-Zeneca, BMS, Boeringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly and Company, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi-Aventis, UCB, Employee of: Director of Imaging Rheumatology bv, D. Muram Employee of: Eli Lilly and Company, J. Alam Employee of: Eli Lilly and Company, S. Beattie Employee of: Eli Lilly and Company, J. Smolen Grant/research support from: Abbvie, Janssen, Eli Lilly and Company, MSD, Pfizer, Roche, Consultant for: Abbvie, Amgen, Astra-Zeneca, Astro, BMS, Celgene, Celltrion, Chugai, Gilead, Glaxo, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi-Aventis, UCB, Speakers bureau: Abbvie, Amgen, Astra-Zeneca, Astro, BMS, Celgene, Celltrion, Chugai, Gilead, Glaxo, ILTOO, Janssen, Eli Lilly and Company, Medimmune, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi-Aventis, UCB