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Lilly and Incyte Announce Baricitinib Efficacy and Safety Data from the Open-Label, Long-Term Extension of the Phase 2b JADA Study in Patients with Rheumatoid Arthritis
Date:6/13/2013

p> Disease
Improvement /
Activity Measure24-WeekResponders/Total
Patients (Percent
Responders)52-WeekResponders/Total
Patients (Percent
Responders)ACR20

149/201 (74%)

139/196 (71%)ACR50

83/201 (41%)

96/197 (49%)ACR70

43/201 (21%)

53/197 (27%)CDAI Remission

34/200 (17%)

40/195 (21%)SDAI Remission

30/195 (15%)

42/194 (22%)DAS28 ESR <2.6

35/200 (18%)

47/195 (24%)DAS28 ESR </= 3.2

55/200 (28%)

82/195 (42%)DAS28 CRP <2.6

59/195 (30%)

80/194 (41%)DAS28 CRP </= 3.2

93/195 (48%)

116/194 (60%)Boolean Remission

19/195 (10%)

32/194 (16%) Safety ResultsSafety signals observed during the open-label extension were consistent with previously reported results of baricitinib. Among patients who remained on the 4 mg dose, treatment-emergent adverse events (TEAEs) occurred in 57 (53 percent); serious adverse events (SAEs) in 11 (10 percent); infections in 34 (31 percent); and serious infections in four (4 percent). Among patients who received the 8 mg dose, TEAEs occurred in 59 (63 percent); SAEs in eight (9 percent); infections in 37 (40 percent); and serious infections in two (2 percent). No opportunistic infections or tuberculosis cases were observed. There was one death in the 8 mg group due to a suspected myocardial infarction.

"In this clinical trial baricitinib showed statistically and clinically significant improvements in the features of this condition, which were maintained throughout a year of treatment. To date, baricitinib has demonstrated an acceptable safety profile and side effects have generally been straightforward to manage. These encouraging findings support further investigation of this new drug in rheumatoid arthritis," said Peter Taylor, M.A., Ph.D., F.R.C.P., Norman Collisson Chair of Musculoskele
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SOURCE Eli Lilly and Company; Incyte Corporation
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