title: Impact of tofacitinib on patient outcomes in rheumatoid arthritis - review of clinical studies.
abstract: Rheumatoid arthritis is a chronic, progressive autoimmune disease associated with inflammation and destruction of joints and systemic effects, which result in significant impact on patient's quality of life and function. Tofacitinib was approved for the treatment of rheumatoid arthritis in the USA in 2012 and subsequently in other countries, but not by the European Medicines Agency. The goal of this review was to evaluate the impact of tofacitinib on patient-reported and patient-specific outcomes from prior clinical studies, focusing on quality of life, functionality, pain, global disease assessment, major adverse consequences, and withdrawals. A total of 13 reports representing 11 clinical studies on tofacitinib in rheumatoid arthritis were identified through PubMed and reference lists in meta-analyses and other reviews. Data on improvements in patient-driven composite tools to measure disease activity in rheumatoid arthritis, such as the Health Assessment Questionnaire, served as a major outcome evaluated in this review and were extracted from each study. Additional data extracted from those clinical studies included patient assessment of pain (using a 0-100 mm visual analog scale), patient global assessment of disease (using a 0-100 mm visual analog scale), patient withdrawals, withdrawals due to adverse effects or lack of effect, and risk of serious adverse effects, serious infections, and deaths. Tofacitinib 5 mg bid appears to have a favorable impact on patient outcomes related to efficacy and safety when compared with baseline values and with comparator disease-modifying antirheumatic drugs and placebo. Improvements were seen in the composite and individual measures of disease activity. Serious adverse effects, other adverse consequences, overall withdrawals, and withdrawals due to adverse effects and lack of efficacy are similar or more favorable for tofacitinib versus comparator disease-modifying antirheumatic drugs and placebo. At this point, tofacitinib appears to have an important role in the treatment of rheumatoid arthritis through improvement in these patient outcomes. However, it may require years of additional clinical studies and postmarketing surveillance to fully characterize the benefit-to-risk ratio of tofacitinib in a larger and diverse patient population.
authors.affiliation: Department of Pharmacy Practice, Thomas J Long School of Pharmacy and Health Sciences, University of the Pacific, Stockton, CA, USA.
authors.forename: Eric G
authors.initials: EG
authors.lastname: Boyce
authors.affiliation: Department of Pharmacy Practice, Thomas J Long School of Pharmacy and Health Sciences, University of the Pacific, Stockton, CA, USA.
authors.forename: Deepti
authors.initials: D
authors.lastname: Vyas
authors.affiliation: Department of Pharmacy Practice, Thomas J Long School of Pharmacy and Health Sciences, University of the Pacific, Stockton, CA, USA.
authors.forename: Edward L
authors.initials: EL
authors.lastname: Rogan
authors.affiliation: Department of Pharmacy Practice, Thomas J Long School of Pharmacy and Health Sciences, University of the Pacific, Stockton, CA, USA.
authors.forename: Cynthia S
authors.initials: CS
authors.lastname: Valle-Oseguera
authors.affiliation: Department of Pharmacy Practice, Thomas J Long School of Pharmacy and Health Sciences, University of the Pacific, Stockton, CA, USA.
authors.forename: Kate M
authors.initials: KM
authors.lastname: O'Dell
keywords: patient-reported outcomes; quality of life; rheumatoid arthritis; tofacitinib
references.citation: J Rheumatol. 2005 May;32(5):811-9
references.pmid: 15868614
references.citation: Arthritis Care Res (Hoboken). 2012 May;64(5):640-7
references.pmid: 22473918
references.citation: Ann Rheum Dis. 2010 Feb;69(2):413-6
references.pmid: 19587388
references.citation: Ann Rheum Dis. 2014 May;73(5):871-82
references.pmid: 23599436
references.citation: Korean J Intern Med. 2014 Sep;29(5):656-63
references.pmid: 25228842
references.citation: N Engl J Med. 2012 Aug 9;367(6):508-19
references.pmid: 22873531
references.citation: BMC Musculoskelet Disord. 2013 Nov 26;14:332
references.pmid: 24279308
references.citation: Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S109-13
references.pmid: 16273794
references.citation: Lancet. 2010 Sep 25;376(9746):1094-108
references.pmid: 20870100
references.citation: Mod Rheumatol. 2015 Jul;25(4):514-21
references.pmid: 25496464
references.citation: Arthritis Rheum. 2009 Jul;60(7):1895-905
references.pmid: 19565475
references.citation: Arthritis Rheumatol. 2014 Nov;66(11):2924-37
references.pmid: 25047021
references.citation: Ann Rheum Dis. 2014 Mar;73(3):529-35
references.pmid: 24401994
references.citation: Arthritis Care Res (Hoboken). 2011 Aug;63(8):1150-8
references.pmid: 21584942
references.citation: J Rheumatol. 2012 Aug;39(8):1559-82
references.pmid: 21921096
references.citation: Lancet. 2013 Feb 9;381(9865):451-60
references.pmid: 23294500
references.citation: Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S4-13
references.pmid: 22588760
references.citation: Arthritis Rheum. 2010 Sep;62(9):2569-81
references.pmid: 20872595
references.citation: Am J Med. 2013 Aug;126(8):730.e9-730.e17
references.pmid: 23885678
references.citation: Ann Rheum Dis. 2016 May;75(5):831-41
references.pmid: 25902789
references.citation: Br J Clin Pharmacol. 2010 Feb;69(2):143-51
references.pmid: 20233177
references.citation: Ann Rheum Dis. 2014 Mar;73(3):492-509
references.pmid: 24161836
references.citation: Arthritis Care Res (Hoboken). 2012 May;64(5):625-39
references.pmid: 22473917
references.citation: N Engl J Med. 2014 Jun 19;370(25):2377-86
references.pmid: 24941177
references.citation: J Rheumatol. 2014 May;41(5):837-52
references.pmid: 24692527
references.citation: Clin Rheumatol. 2013 Oct;32(10):1415-24
references.pmid: 23877486
references.citation: Arthritis Rheum. 2012 Apr;64(4):970-81
references.pmid: 22006202
references.citation: Ann Rheum Dis. 2016 Apr;75(4):687-95
references.pmid: 25795907
references.citation: Arthritis Rheum. 2012 Mar;64(3):617-29
references.pmid: 21952978
references.citation: Arthritis Care Res (Hoboken). 2015 Apr;67(4):475-83
references.pmid: 25186034
references.citation: Arthritis Rheum. 2013 Mar;65(3):559-70
references.pmid: 23348607
references.citation: Ann Intern Med. 2013 Aug 20;159(4):253-61
references.pmid: 24026258
references.citation: Arthritis Rheumatol. 2015 Jan;67(1):117-27
references.pmid: 25303044
references.citation: BMC Musculoskelet Disord. 2013 Oct 18;14:298
references.pmid: 24139404
references.citation: Ann Pharmacother. 2013 Nov;47(11):1524-31
references.pmid: 24285764
references.citation: N Engl J Med. 2012 Aug 9;367(6):495-507
references.pmid: 22873530
references.citation: Ann Rheum Dis. 2015 Mar;74(3):480-9
references.pmid: 25561362
references.citation: Clin Rheumatol. 2014 Feb;33(2):165-73
references.pmid: 24389749