Efficacy and safety at 24 weeks of daily clinical use of tofacitinib in patients with rheumatoid arthritis

Abstract

ObjectiveWe evaluated the efficacy and safety of tofacitinib in patients with rheumatoid arthritis (RA) in a real-world setting.MethodsSeventy consecutive patients, for whom tofacitinib was initiated between November 2013 and May 2016, were enrolled. All patients fulfilled the 2010 ACR/EULAR classification criteria for RA. All patients received 5 mg of tofacitinib twice daily and were followed for 24 weeks. Clinical disease activity indicated by disease activity score (DAS)28-ESR, the simplified disease activity index, and the clinical disease activity index as well as adverse events (AEs) were evaluated. Statistical analysis was performed to determine which baseline variables influenced the efficacy of tofacitinib at 24 weeks.ResultsFifty-eight patients (82.9%) continued tofacitinib at 24 weeks. Clinical disease activity rapidly and significantly decreased, and this efficacy continued throughout the 24 weeks: i.e., DAS28-ESR decreased from 5.04 ± 1.33 at baseline to 3.83 ± 1.11 at 4 weeks and 3.53 ± 1.17 at 24 weeks (P<0.0001, vs. baseline). 15 AEs including 5 herpes zoster infection occurred during tofacitinib treatment. The efficacy of tofacitinib was not changed in patients without concomitant use of methotrexate (MTX) or patients whose treatment with tocilizumab (TCZ) failed. Multivariable logistic analysis showed that the number of biologic DMARDs (bDMARDs) previously used was independently associated with achievement of DAS-low disease activity.ConclusionsOur present study suggests that tofacitinib is effective in real-world settings even without concomitant MTX use or after switching from TCZ. Our results also suggest that its efficacy diminishes if started after use of multiple bDMARDs.

Herpes Zoster in rheumatoid arthritis patients receiving tofacitinib, a single center experience from Taiwan

“…[ 16 ] Ours are the first post-market single center data in ethnically Taiwanese RA patients, who have incidence of HZ commensurate with that of predominantly European populations, but lower than Japanese or Koreans. Iwamoto et al, [ 17 ] reported 5 HZ cases in Japanese RA patients receiving tofacitinib, an incidence rate of 18.7 per 100 person-years, which is much higher than in our study or clinical trials. [ 9 ] Human leukocyte antigen gene and IL-10 polymorphism were associated with susceptibility to HZ in Taiwan and Korean population.…”

JAK‐STAT signaling pathway inhibition: a role for treatment of discoid lupus erythematosus and dermatomyositis

“…More serious infections and ones leading to cancers have been reported but in patients who are concomitantly on methotrexate, corticosteroids, or other immunosuppressant drugs after a kidney transplant. 33,34 Conclusion This review article presents the current understanding of the pathophysiology of DLE and DM, which supports our proposal for the use of JAK inhibitors in these patients. However, based on limited literature to support our findings, it is suggested that JAK inhibitors should be considered as an option in refractory cases of these diseases.…”

“…Side effects of JAK inhibitors most commonly include infections, headache, and diarrhea. More serious infections and ones leading to cancers have been reported but in patients who are concomitantly on methotrexate, corticosteroids, or other immunosuppressant drugs after a kidney transplant …”

Tofacitinib Versus Non-Tumor Necrosis Factor Biologics for Patients With Active Rheumatoid Arthritis

“…Moreover, the drug is orally administered, which is advantageous for drug adherence in patients who dislike subcutaneous or intravenous injection. 8 Iwamoto et al 9 very recently reported that Tofa was effective even without MTX use or after switching from tocilizumab after 24 weeks of treatment. In this study, we compared the effectiveness of Tofa and non-TNF biologics in biologics-naïve groups that had been unresponsive to MTX >8 mg for more than 3 months.…”