Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, for the treatment of rheumatoid arthritis in open-Label, longterm extension studies

Jürgen Wollenhaupt, Joel Silverfield, Eun Bong Lee Prof., Jeffrey R. Curtis, Susan P. Wood, Koshika Soma, Chudy I. Nduaka, Birgitta Benda, David Gruben, Hiroyuki Nakamura, Yoshihiro Komuro, Samuel H. Zwillich, Lisy Wang, Richard J. Riese

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Abstract

Objective: To describe the longterm safety and efficacy profile of tofacitinib in patients with moderate to severe active rheumatoid arthritis (RA). Methods: Data were pooled from 2 open-label studies (NCT00413699, NCT00661661) involving patients who had participated in qualifying phase I, II, or III index studies of tofacitinib. Safety data included over 60 months of observation; efficacy data are reported up to Month 48. Treatment was initiated with tofacitinib 5 or 10 mg twice daily. Primary endpoints were adverse events (AE) and laboratory safety data. Secondary endpoints included American College of Rheumatology (ACR) response rates, and Disease Activity Score (28 joints) (DAS28)-4[erythrocyte sedimentation rate (ESR)] and Health Assessment Questionnaire-Disability Index (HAQ-DI) assessments. Results: Overall, 4102 patients were treated for 5963 patient-years; mean (maximum) treatment duration was 531 (1844) days; 20.8% of patients discontinued treatment over 60 months. The most common AE were nasopharyngitis (12.7%) and upper respiratory tract infection (10.5%). Serious AE were reported in 15.4% of patients with an exposure-estimated incidence rate of 11.1 events/100 patient-years. Serious infections were reported in 4.5% of patients with an exposure-estimated incidence rate of 3.1 events/100 patient-years (95% CI: 2.66-3.55). Mean values for laboratory variables were stable over time and consistent with phase II and III studies. Persistent efficacy was demonstrated through Month 48, as measured by ACR response rate (ACR20/50/70) DAS28-4-ESR, and HAQ-DI. Safety and efficacy were similar for patients receiving tofacitinib as monotherapy or with background nonbiologic disease-modifying antirheumatic drugs. Conclusion: Tofacitinib demonstrated consistent safety and persistent efficacy over 48 months in patients with RA.

Original languageEnglish
Pages (from-to)837-852
Number of pages16
JournalJournal of Rheumatology
Volume41
Issue number5
DOIs
StatePublished - May 2014

Fingerprint

Janus Kinases
Rheumatoid Arthritis
Safety
Therapeutics
Blood Sedimentation
tofacitinib
Nasopharyngitis
Joints
Antirheumatic Agents
Incidence
Health
Rheumatology
Respiratory Tract Infections

Keywords

  • Agents
  • Antirheumatic
  • Arthritis
  • Clinical
  • Rheumatoid
  • Tofacitinib
  • Trial

Cite this

Wollenhaupt, Jürgen ; Silverfield, Joel ; Lee Prof., Eun Bong ; Curtis, Jeffrey R. ; Wood, Susan P. ; Soma, Koshika ; Nduaka, Chudy I. ; Benda, Birgitta ; Gruben, David ; Nakamura, Hiroyuki ; Komuro, Yoshihiro ; Zwillich, Samuel H. ; Wang, Lisy ; Riese, Richard J. / Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, for the treatment of rheumatoid arthritis in open-Label, longterm extension studies. In: Journal of Rheumatology. 2014 ; Vol. 41, No. 5. pp. 837-852.
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abstract = "Objective: To describe the longterm safety and efficacy profile of tofacitinib in patients with moderate to severe active rheumatoid arthritis (RA). Methods: Data were pooled from 2 open-label studies (NCT00413699, NCT00661661) involving patients who had participated in qualifying phase I, II, or III index studies of tofacitinib. Safety data included over 60 months of observation; efficacy data are reported up to Month 48. Treatment was initiated with tofacitinib 5 or 10 mg twice daily. Primary endpoints were adverse events (AE) and laboratory safety data. Secondary endpoints included American College of Rheumatology (ACR) response rates, and Disease Activity Score (28 joints) (DAS28)-4[erythrocyte sedimentation rate (ESR)] and Health Assessment Questionnaire-Disability Index (HAQ-DI) assessments. Results: Overall, 4102 patients were treated for 5963 patient-years; mean (maximum) treatment duration was 531 (1844) days; 20.8{\%} of patients discontinued treatment over 60 months. The most common AE were nasopharyngitis (12.7{\%}) and upper respiratory tract infection (10.5{\%}). Serious AE were reported in 15.4{\%} of patients with an exposure-estimated incidence rate of 11.1 events/100 patient-years. Serious infections were reported in 4.5{\%} of patients with an exposure-estimated incidence rate of 3.1 events/100 patient-years (95{\%} CI: 2.66-3.55). Mean values for laboratory variables were stable over time and consistent with phase II and III studies. Persistent efficacy was demonstrated through Month 48, as measured by ACR response rate (ACR20/50/70) DAS28-4-ESR, and HAQ-DI. Safety and efficacy were similar for patients receiving tofacitinib as monotherapy or with background nonbiologic disease-modifying antirheumatic drugs. Conclusion: Tofacitinib demonstrated consistent safety and persistent efficacy over 48 months in patients with RA.",
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author = "J{\"u}rgen Wollenhaupt and Joel Silverfield and {Lee Prof.}, {Eun Bong} and Curtis, {Jeffrey R.} and Wood, {Susan P.} and Koshika Soma and Nduaka, {Chudy I.} and Birgitta Benda and David Gruben and Hiroyuki Nakamura and Yoshihiro Komuro and Zwillich, {Samuel H.} and Lisy Wang and Riese, {Richard J.}",
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Wollenhaupt, J, Silverfield, J, Lee Prof., EB, Curtis, JR, Wood, SP, Soma, K, Nduaka, CI, Benda, B, Gruben, D, Nakamura, H, Komuro, Y, Zwillich, SH, Wang, L & Riese, RJ 2014, 'Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, for the treatment of rheumatoid arthritis in open-Label, longterm extension studies', Journal of Rheumatology, vol. 41, no. 5, pp. 837-852. https://doi.org/10.3899/jrheum.130683

Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, for the treatment of rheumatoid arthritis in open-Label, longterm extension studies. / Wollenhaupt, Jürgen; Silverfield, Joel; Lee Prof., Eun Bong; Curtis, Jeffrey R.; Wood, Susan P.; Soma, Koshika; Nduaka, Chudy I.; Benda, Birgitta; Gruben, David; Nakamura, Hiroyuki; Komuro, Yoshihiro; Zwillich, Samuel H.; Wang, Lisy; Riese, Richard J.

In: Journal of Rheumatology, Vol. 41, No. 5, 05.2014, p. 837-852.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Safety and efficacy of tofacitinib, an oral janus kinase inhibitor, for the treatment of rheumatoid arthritis in open-Label, longterm extension studies

AU - Wollenhaupt, Jürgen

AU - Silverfield, Joel

AU - Lee Prof., Eun Bong

AU - Curtis, Jeffrey R.

AU - Wood, Susan P.

AU - Soma, Koshika

AU - Nduaka, Chudy I.

AU - Benda, Birgitta

AU - Gruben, David

AU - Nakamura, Hiroyuki

AU - Komuro, Yoshihiro

AU - Zwillich, Samuel H.

AU - Wang, Lisy

AU - Riese, Richard J.

PY - 2014/5

Y1 - 2014/5

N2 - Objective: To describe the longterm safety and efficacy profile of tofacitinib in patients with moderate to severe active rheumatoid arthritis (RA). Methods: Data were pooled from 2 open-label studies (NCT00413699, NCT00661661) involving patients who had participated in qualifying phase I, II, or III index studies of tofacitinib. Safety data included over 60 months of observation; efficacy data are reported up to Month 48. Treatment was initiated with tofacitinib 5 or 10 mg twice daily. Primary endpoints were adverse events (AE) and laboratory safety data. Secondary endpoints included American College of Rheumatology (ACR) response rates, and Disease Activity Score (28 joints) (DAS28)-4[erythrocyte sedimentation rate (ESR)] and Health Assessment Questionnaire-Disability Index (HAQ-DI) assessments. Results: Overall, 4102 patients were treated for 5963 patient-years; mean (maximum) treatment duration was 531 (1844) days; 20.8% of patients discontinued treatment over 60 months. The most common AE were nasopharyngitis (12.7%) and upper respiratory tract infection (10.5%). Serious AE were reported in 15.4% of patients with an exposure-estimated incidence rate of 11.1 events/100 patient-years. Serious infections were reported in 4.5% of patients with an exposure-estimated incidence rate of 3.1 events/100 patient-years (95% CI: 2.66-3.55). Mean values for laboratory variables were stable over time and consistent with phase II and III studies. Persistent efficacy was demonstrated through Month 48, as measured by ACR response rate (ACR20/50/70) DAS28-4-ESR, and HAQ-DI. Safety and efficacy were similar for patients receiving tofacitinib as monotherapy or with background nonbiologic disease-modifying antirheumatic drugs. Conclusion: Tofacitinib demonstrated consistent safety and persistent efficacy over 48 months in patients with RA.

AB - Objective: To describe the longterm safety and efficacy profile of tofacitinib in patients with moderate to severe active rheumatoid arthritis (RA). Methods: Data were pooled from 2 open-label studies (NCT00413699, NCT00661661) involving patients who had participated in qualifying phase I, II, or III index studies of tofacitinib. Safety data included over 60 months of observation; efficacy data are reported up to Month 48. Treatment was initiated with tofacitinib 5 or 10 mg twice daily. Primary endpoints were adverse events (AE) and laboratory safety data. Secondary endpoints included American College of Rheumatology (ACR) response rates, and Disease Activity Score (28 joints) (DAS28)-4[erythrocyte sedimentation rate (ESR)] and Health Assessment Questionnaire-Disability Index (HAQ-DI) assessments. Results: Overall, 4102 patients were treated for 5963 patient-years; mean (maximum) treatment duration was 531 (1844) days; 20.8% of patients discontinued treatment over 60 months. The most common AE were nasopharyngitis (12.7%) and upper respiratory tract infection (10.5%). Serious AE were reported in 15.4% of patients with an exposure-estimated incidence rate of 11.1 events/100 patient-years. Serious infections were reported in 4.5% of patients with an exposure-estimated incidence rate of 3.1 events/100 patient-years (95% CI: 2.66-3.55). Mean values for laboratory variables were stable over time and consistent with phase II and III studies. Persistent efficacy was demonstrated through Month 48, as measured by ACR response rate (ACR20/50/70) DAS28-4-ESR, and HAQ-DI. Safety and efficacy were similar for patients receiving tofacitinib as monotherapy or with background nonbiologic disease-modifying antirheumatic drugs. Conclusion: Tofacitinib demonstrated consistent safety and persistent efficacy over 48 months in patients with RA.

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KW - Antirheumatic

KW - Arthritis

KW - Clinical

KW - Rheumatoid

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