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Persistence of Tofacitinib in the Treatment of Rheumatoid Arthritis in Open-Label, Long-Term Extension Studies up to 9.5 Years


Pope JE1, Keystone E2, Jamal S3, Wang L4, Fallon L5, Woolcott J5, Lazariciu I6, Chapman D7, Haraoui B8. ACR Open Rheumatol. 2019 Mar 28;1(2):73-82. doi: 10.1002/acr2.1010. eCollection 2019 Apr.

Author Information

1 Western University London Ontario Canada.

2 University of Toronto Ontario Canada.

3 University of British Columbia Vancouver British Columbia Canada.

4 Pfizer Inc Groton Connecticut.

5 Pfizer Canada Inc Montreal Quebec Canada.

6 IQVIA Montreal Quebec Canada.

7 Pfizer Inc New York New York.

8 Institut de Rhumatologie de Montréal Montreal Quebec Canada.



Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This post hoc analysis evaluated tofacitinib persistence in patients with RA in long-term extension (LTE) studies up to 9.5 years.


Data were pooled from two LTE studies: ORAL Sequel (NCT00413699) and Study A3921041 (NCT00661661). Patients received tofacitinib 5 or 10 mg twice daily (BID), as monotherapy or with background conventional synthetic disease-modifying antirheumatic drugs. Kaplan-Meier estimates for tofacitinib drug survival and reasons for discontinuation were evaluated. Baseline factors were analyzed as predictors of persistence.


In 4967 tofacitinib-treated patients entering LTE studies, mean (maximum) treatment duration was 3.5 (9.4) years. Median drug survival (95% confidence interval) was 4.9 (4.7, 5.1) years. Estimated 2- and 5-year drug survival rates were 75.5% and 49.4%, respectively. Median drug survival was similar between the tofacitinib 5 and 10 mg BID groups, and slightly higher for patients receiving tofacitinib monotherapy versus combination therapy. Overall, 50.7% of patients discontinued tofacitinib; of these, 47.2% were due to adverse events and 7.1% for lack/loss of efficacy. An increased risk of discontinuation was associated with baseline diabetes, hypertension, negative anticyclic citrullinated peptide (anti-CCP), negative rheumatoid factor (RF), and inadequate response to tumor necrosis factor inhibitors (TNFi-IR).


Median drug survival of tofacitinib-treated patients participating in LTE studies was approximately 5 years and was similar for tofacitinib dosed at 5 and 10 mg BID. Reduced drug survival was associated with negative anti-CCP/RF status, TNFi-IR, and certain comorbidities. These data support tofacitinib use for long-term management of RA.