Abstract
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We evaluated the effect of concomitant methotrexate (MTX) or glucocorticoid (GC) use on tofacitinib clinical efficacy. Data were pooled from two open-label, long-term extension studies of tofacitinib 5 or 10mg twice daily in patients with RA. Response according to Clinical Disease Activity Index (CDAI) was assessed separately in patients who discontinued (no MTX/GC use within 30days prior to year-3 visit; assessment at month 3/year 3) or initiated (on/before year 3; assessment at initiation and year 3) MTX/GC. By year 3, among patients receiving background MTX at baseline, 186/1608 (11.6%) discontinued MTX, and 319/1434 (22.2%) patients receiving GC at baseline discontinued GC. Overall, 70.4/69.1% of patients who discontinued/continued MTX and 72.7/65.9% who discontinued/continued GC achieved CDAI remission or low disease activity (LDA) at year 3. Month 3 remission/LDA rates were maintained at year 3 in the majority of patients, irrespective of MTX/GC discontinuation/continuation. By year 3, 6.2% of patients receiving tofacitinib without MTX at baseline had initiated concomitant MTX, and 25.1% receiving tofacitinib without GC initiated GC; 69.0% and 45.4% initiating MTX or GC, respectively, had a CDAI-defined incomplete response prior to initiation. RA signs/symptoms improved following MTX initiation; only modest improvement was observed with GC initiation. Patients achieving remission/LDA with tofacitinib may discontinue MTX or GC and maintain treatment response. Patients with an incomplete response may benefit from adding concomitant MTX. Pfizer Inc. Study A3921024 [NCT00413699] and StudyA3921041 [NCT00661661].
Highlights
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA)
The efficacy and safety of tofacitinib 5 and 10 mg twice daily (BID) administered as monotherapy or in combination with conventional synthetic diseasemodifying antirheumatic drugs, mainly MTX, in patients with active RA have been demonstrated in phase II [6,7,8,9,10], phase III [11,12,13,14,15,16], and phase IIIb/IV [17] studies of up to 24 months’ duration and in long-term extension (LTE) studies with up to 114 months of observation [18,19,20]
Among all tofacitinib-treated patients who discontinued MTX, the mean number of days spent off MTX prior to the year-3 visit was 577 (563) days
Summary
Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Treatment options for rheumatoid arthritis (RA) include multiple classes of agents, and patients often receive background or concomitant treatment [1, 2] such as methotrexate (MTX) or glucocorticoid (GC), to improve or expedite clinical response. The efficacy and safety of tofacitinib 5 and 10 mg twice daily (BID) administered as monotherapy or in combination with conventional synthetic diseasemodifying antirheumatic drugs (csDMARDs), mainly MTX, in patients with active RA have been demonstrated in phase II [6,7,8,9,10], phase III [11,12,13,14,15,16], and phase IIIb/IV [17] studies of up to 24 months’ duration and in long-term extension (LTE) studies with up to 114 months of observation [18,19,20].
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
