Safety and efficacy of baricitinib through 128 weeks in an open-label, longterm extension study in patients with rheumatoid arthritis

Journal of Rheumatology

Volumn 45, Issue 1, 2018, Pages 14-21

  Keystone, Edward C ^a   Genovese, Mark C ^b   Schlichting, Douglas E ^c   De La Torre, Inmaculada ^c   Beattie, Scott D ^c   Rooney, Terence P ^c   Taylor, Peter C ^d  

^a MOUNT SINAI HOSPITAL   (Canada)

^b STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c ELI LILLY AND COMPANY   (United States)

^d UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

Baricitinib; Clinical efficacy safety; Longterm; Phase II; Rheumatoid arthritis

Indexed keywords

BARICITINIB; ANTIRHEUMATIC AGENT; AZETIDINE DERIVATIVE; C REACTIVE PROTEIN; METHOTREXATE; SULFONAMIDE;

ACUTE HEPATITIS B; ADULT; ANEMIA; ARTICLE; BASAL CELL CARCINOMA; COLITIS; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; HEART INFARCTION; HERPES SIMPLEX; HERPES ZOSTER; HUMAN; HYPERTRANSAMINASEMIA; INFECTION; MAJOR CLINICAL STUDY; MALE; MORTALITY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; SIDE EFFECT; THROMBOCYTOSIS; TREATMENT DURATION; TREATMENT OUTCOME; ADOLESCENT; AGED; CLINICAL TRIAL; COMBINATION DRUG THERAPY; ERYTHROCYTE SEDIMENTATION RATE; FOLLOW UP; MIDDLE AGED; ORAL DRUG ADMINISTRATION; SEVERITY OF ILLNESS INDEX; YOUNG ADULT;

ADMINISTRATION, ORAL; ADOLESCENT; ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; AZETIDINES; BLOOD SEDIMENTATION; C-REACTIVE PROTEIN; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; METHOTREXATE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; SULFONAMIDES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 85040089255     PISSN: 0315162X     EISSN: 14992752     Source Type: Journal    
DOI: 10.3899/jrheum.161161     Document Type: Article

References (9)

1. O'Shea JJ, Kontzias A, Yamaoka K, Tanaka Y, Laurence A. Janus kinase inhibitors in autoimmune diseases. Ann Rheum Dis 2013;72 Suppl 2:ii111-5.
2. Fridman JS, Scherle PA, Collins R, Burn TC, Li Y, Li J, et al. Selective inhibition of JAK1 and JAK2 is efficacious in rodent models of arthritis: preclinical characterization of INCB028050. J Immunol 2010;184:5298-307.
3. Greenwald MW, Fidelus-Gort R, Levy R, Liang J, Vaddi K, Williams W V, et al. A randomized dose-ranging, placebo-controlled study of INCB028050, a selective JAK1 and JAK2 inhibitor in subjects with active rheumatoid arthritis [abstract]. Arthritis Rheum 2010;62 Suppl 10:S911.
4. Tanaka Y, Emoto K, Cai Z, Aoki T, Schlichting D, Rooney T, et al. Efficacy and safety of baricitinib in Japanese patients with active rheumatoid arthritis receiving background methotrexate therapy: a 12-week, double-blind, randomized placebo-controlled study. J Rheumatol 2016;43:504-11.
5. Keystone EC, Taylor PC, Drescher E, Schlichting DE, Beattie SD, Berclaz PY, et al. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Ann Rheum Dis 2015;74:333-40.
6. Taylor P, Genovese MC, Keystone E, Schlichting D, Beattie S, Macias W. Baricitinib, an oral janus kinase inhibitor, in the treatment of rheumatoid arthritis: safety and efficacy in open-label, long-term extension study [abstract]. Ann Rheum Dis 2013;72 Suppl 3:A65-6.
7. Winthrop KL, Yamanaka H, Valdez H, Mortensen E, Chew R, Krishnaswami S, et al. Herpes zoster and tofacitinib therapy in patients with rheumatoid arthritis. Arthritis Rheum 2014; 66:2675-84.
8. Yun H, Xie F, Delzell E, Chen L, Levitan EB, Lewis JD, et al. Risks of herpes zoster in patients with rheumatoid arthritis according to biologic disease-modifying therapy. Arthritis Care Res 2015;67:731-6.
9. Smolen J, Genovese M, Takeuchi T, Hyslop D, Macias WL, Rooney TP, et al. Safety profile of baricitinib in patients with active RA: an integrated analysis [abstract]. Ann Rheum Dis 2016;75 Suppl 2:243-4.