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EULAR 2017 | Daily Highlights
EFFECT OF STARTING DOSE OF BARICITINIB IN ACHIEVING SUSTAINED LOW DISEASE ACTIVITYAbstract: FRI0089
Authors: J. R. Curtis1,*, A. Kavanaugh2, D. van der Heijde3, D. Muram4, J. Alam4, S. Beattie4, J. S. Smolen5
1Univ of Alabama at Birmingham, Birmingham, 2UC San Diego School of Medicine, La Jolla, United States, 3Leiden University Medical Centre, Leiden, Netherlands, 4Eli Lilly and Company, Indianapolis, United States, 5Medical University of Vienna, Vienna, Austria
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).
To determine the effect of starting dose of bari on achieving and sustaining low disease activity (LDA).
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.
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.
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.
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
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
Baricitinib (BARI) is expected to arrive on the Swiss market this summer under the brand name Olumniant®. It will be the second agent available in the class of JAK-inhibitors. Most likely two dosages of BARI will be available, 2 and 4 mg per day. Both the above posters deal with the question of what the optimal dose of this new medication is.In the first abstract (FRI0089), the authors examined the impact of the starting dose of BARI on the likelihood of attaining long-term low disease activity in RCTs and extension studies. The authors found that the dose of 4 mg/day was associated with slightly higher chances of reaching low disease state and a shorter time to response. However, the difference between 2 and 4 mg seems relatively small (a difference of only a few percent) and may or not warrant a higher dose.In the second abstract (SAT0072), the authors investigated if responders to 4 mg/day of BARI could be safely reduced to 2 mg/day. This was a nested randomized trial in the extension studies of the original RCTs. Patients who achieved sustained disease control with BARI 4mg were randomized to either BARI 2 mg or BARI 4 mg in blinded fashion. The results suggest that reducing BARI to the lower dose is associated with a slight increase in flares (about 10% more flares), but the vast majority of patients maintained the control of the disease even with the lower dose. Interestingly, the switch to the lower dose was associated with a lower rate of non-serious infections. Overall, one gets the impression that 4 mg of BARI is slightly more potent and probably warranted for patients with more active and treatment-resistant RA. However, for patients with less severe disease and who respond well to the higher dose, a dose tapering might be considered, in particular if infections are a concern.
Prof. Dr. Axel Finckh
Geneva University Hospital