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Table 2 Incidence rates for all-cause AEs of special interest

From: Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: final results of a global, open-label, long-term extension study

 

All patients (IR (95% CI) [n/N])

Patients receiving tofacitinib as combination therapy (stay-on background csDMARDs) (IR (95% CI) [n/N])

Patients receiving tofacitinib as monotherapy (stay-on monotherapy) (IR (95% CI) [n/N])

Tofacitinib 5 mg BID

Tofacitinib 10 mg BID

All tofacitinib

Tofacitinib 5 mg BID

Tofacitinib 10 mg BID

All tofacitinib

Tofacitinib 5 mg BID

Tofacitinib 10 mg BID

All tofacitinib

Malignancy related

 NMSC

0.6 (0.4, 0.9)

[28/1123]

0.8 (0.6, 0.9)

[88/3358]

0.7 (0.6, 0.9)

[116/4481]

0.4 (0.2, 0.7)

[9/630]

0.9 (0.6, 1.1)

[51/1834]

0.7 (0.5, 0.9)

[60/2464]

0.8 (0.4, 1.4)

[10/305]

0.4 (0.2, 0.6)

[13/993]

0.5 (0.3, 0.7)

[23/1298]

 Malignancies excluding NMSC

0.8 (0.6, 1.1)

[38/1123]

0.8 (0.7, 1.0)

[100/3358]

0.8 (0.7, 1.0)

[138/4481]

1.0 (0.7, 1.5)

[25/630]

0.8 (0.6, 1.0)

[48/1834]

0.9 (0.7, 1.1)

[73/2464]

0.8 (0.4, 1.4)

[10/305]

0.9 (0.6, 1.3)

[31/993]

0.9 (0.6, 1.2)

[41/1298]

 Lymphoma

0.0 (0.0, 0.1)

[1/1123]

0.1 (0.0, 0.1)

[8/3358]

0.1 (0.0, 0.1)

[9/4481]

0.0 (0.0, 0.2)

[1/630]

0.1 (0.0, 0.2)

[5/1834]

0.1 (0.0, 0.2)

[6/2464]

0 (0.0, 0.3)

[0/305]

0.0 (0.0, 0.2)

[1/993]

0.0 (0.0, 0.1)

[1/1298]

 Melanomas

0.1 (0.0, 0.2)

[3/1123]

0.1 (0.0, 0.2)

[10/3358]

0.1 (0.0, 0.1)

[13/4481]

0.1 (0.0, 0.3)

[2/630]

0.1 (0.0, 0.2)

[4/1834]

0.1 (0.0, 0.2)

[6/2464]

0.1 (0.0, 0.4)

[1/305]

0.1 (0.1, 0.3)

[5/993]

0.1 (0.1, 0.3)

[6/1298]

 Breast cancera

0.2 (0.1, 0.3)

[6/927]

0.2 (0.1, 0.3)

[17/2744]

0.2 (0.1, 0.3)

[23/3671]

0.3 (0.1, 0.6)

[5/512]

0.2 (0.1, 0.4)

[10/1498]

0.2 (0.1, 0.4)

[15/2010]

0 (0.0, 0.3)

[0/261]

0.1 (0.0, 0.3)

[3/798]

0.1 (0.0, 0.2)

[3/1059]

 Lung cancer

0.1 (0.1, 0.3)

[6/1123]

0.2 (0.1, 0.3)

[20/3358]

0.2 (0.1, 0.2)

[26/4481]

0.1 (0.0, 0.4)

[3/630]

0.2 (0.1, 0.3)

[12/1834]

0.2 (0.1, 0.3)

[15/2464]

0.2 (0.0, 0.6)

[2/305]

0.2 (0.1, 0.4)

[6/993]

0.2 (0.1, 0.3)

[8/1298]

Infection related

 All serious infections

1.9 (1.6, 2.4)

[91/1123]

2.6 (2.3, 2.9)

[304/3358]

2.4 (2.2, 2.6)

[395/4481]

1.9 (1.4, 2.5)

[46/630]

3.0 (2.6, 3.5)

[184/1834]

2.7 (2.4, 3.1)

[230/2464]

2.1 (1.4, 3.0)

[27/305]

2.3 (1.9, 2.9)

[81/993]

2.3 (1.9, 2.7)

[108/1298]

 Tuberculosis

0.1 (0.0, 0.2)

[5/1123]

0.2 (0.1, 0.3)

[20/3358]

0.2 (0.1, 0.2)

[25/4481]

0.2 (0.0, 0.4)

[4/630]

0.2 (0.1, 0.3)

[12/1834]

0.2 (0.1, 0.3)

[16/2464]

0.1 (0.0, 0.4)

[1/305]

0.2 (0.1, 0.4)

[6/993]

0.2 (0.1, 0.3)

[7/1298]

 Herpes zoster

2.3 (2.3, 3.3)

[120/1123]

3.7 (3.4, 4.1)

[406/3358]

3.4 (3.2, 3.7)

[526/4481]

2.2 (1.7, 2.9)

[52/630]

4.1 (3.6, 4.7)

[233/1834]

3.6 (3.2, 4.0)

[285/2464]

2.4 (1.6, 3.5)

[29/305]

2.3 (1.8, 2.9)

[77/993]

2.4 (1.9, 2.8)

[106/1298]

 Opportunistic infections excluding tuberculosis

0.1 (0.0, 0.2)

[4/1123]

0.5 (0.4, 0.7)

[60/3358]

0.4 (0.3, 0.5)

[64/4481]

0.0 (0.0, 0.2)

[1/630]

0.6 (0.4, 0.8)

[36/1834]

0.4 (0.3, 0.6)

[37/2464]

0.2 (0.0, 0.6)

[2/305]

0.4 (0.2, 0.7)

[14/993]

0.3 (0.2, 0.5)

[16/1298]

Mortality related

 Mortality attributed to a cardiovascular event

0.2 (0.1, 0.3)

[7/1046]

0.1 (0.1, 0.2)

[12/3358]

0.1 (0.1, 0.2)

[19/4404]

0.1 (0.0, 0.4)

[3/572]

0.1 (0.1, 0.3)

[8/1834]

0.1 (0.1, 0.2)

[11/2406]

0.3 (0.1, 0.8)

[4/289]

0.1 (0.0, 0.2)

[2/993]

0.1 (0.1, 0.3)

[6/1282]

 Mortality due to infections

0.1 (0.0, 0.2)

[4/1123]

0.1 (0.0, 0.1)

[9/3358]

0.1 (0.0, 0.1)

[13/4481]

0.1 (0.0, 0.3)

[2/630]

0.1 (0.0, 0.2)

[4/1834]

0.1 (0.0, 0.2)

[6/2464]

0.1 (0.0, 0.4)

[1/305]

0.1 (0.0, 0.3)

[4/993]

0.1 (0.0, 0.2)

[5/1298]

 Mortality due to malignancy

0.0 (0.0, 0.1)

[1/1123]

0.0 (0.0, 0.1)

[3/3358]

0.0 (0.0, 0.1)

[4/4481]

0 (0.0, 0.2)

[0/630]

0.0 (0.0, 0.1)

[2/1834]

0.0 (0.0, 0.1)

[2/2464]

0.1 (0.0, 0.4)

[1/305]

0.0 (0.0, 0.2)

[1/993]

0.0 (0.0, 0.2)

[2/1298]

Other

 Composite MACE

0.5 (0.3, 0.7)

[20/1046]

0.4 (0.3, 0.5)

[42/3358]

0.4 (0.3, 0.5)

[62/4404]

0.5 (0.3, 0.9)

[11/572]

0.5 (0.3, 0.7)

[29/1834]

0.5 (0.4, 0.7)

[40/2406]

0.5 (0.2, 1.1)

[6/289]

0.2 (0.1, 0.4)

[6/993]

0.3 (0.1, 0.4)

[12/1282]

 Gastrointestinal perforation

0.1 (0.0, 0.2)

[3/1123]

0.2 (0.1, 0.3)

[20/3358]

0.1 (0.1, 0.2)

[23/4481]

0.0 (0.0, 0.2)

[1/630]

0.2 (0.1, 0.4)

[13/1834]

0.2 (0.1, 0.3)

[14/2464]

0.1 (0.0, 0.4)

[1/305]

0.1 (0.1, 0.3)

[5/993]

0.1 (0.1, 0.3)

[6/1298]

 Interstitial lung disease

0.2 (0.1, 0.4)

[10/1123]

0.2 (0.1, 0.3)

[22/3358]

0.2 (0.1, 0.3)

[32/4481]

0.2 (0.0, 0.4)

[4/630]

0.3 (0.1, 0.4)

[15/1834]

0.2 (0.1, 0.4)

[19/2464]

0.3 (0.1, 0.8)

[4/305]

0.1 (0.0, 0.3)

[3/993]

0.2 (0.1, 0.3)

[7/1298]

 Deep vein thrombosis

0.1 (0.1, 0.3)

[6/1123]

0.1 (0.1, 0.2)

[17/3358]

0.1 (0.1, 0.2)

[23/4481]

0.1 (0.0, 0.4)

[3/630]

0.1 (0.1, 0.3)

[8/1834]

0.1 (0.1, 0.2)

[11/2464]

0.1 (0.0, 0.4)

[1/305]

0.2 (0.1, 0.4)

[6/993]

0.2 (0.1, 0.3)

[7/1298]

 Pulmonary embolism

0.1 (0.0, 0.3)

[5/1123]

0.1 (0.1, 0.2)

[16/3358]

0.1 (0.1, 0.2)

[21/4481]

0.1 (0.0, 0.3)

[2/630]

0.1 (0.1, 0.3)

[8/1834]

0.1 (0.1, 0.2)

[10/2464]

0.1 (0.0, 0.4)

[1/305]

0.2 (0.1, 0.4)

[6/993]

0.2 (0.1, 0.3)

[7/1298]

  1. IR is the number of patients with events per 100 patient-years. Tofacitinib was dosed at 1, 3, 5, 10, 15, and 30 mg BID, or 20 mg QD, as monotherapy or in combination with background csDMARDs (mostly MTX). Total tofacitinib exposure was 16,291 patient-years (4683 patient-years in the 5 mg BID population and 11,608 patient-years in the 10 mg BID population). Tofacitinib exposure for female patients was 13,476 patient-years (3888 patient-years in the 5 mg BID population and 9587 patient-years in the 10 mg BID population). Tofacitinib exposure for patients in the cardiac event analysis population was 15,823 patient-years (4257 patient-years in the 5 mg BID population and 11,566 patient-years in the 10 mg BID population). As per the protocol, cardiovascular events were adjudicated from February 2009, opportunistic infections from February 2013, hepatic events from December 2012, gastrointestinal events from December 2014, and interstitial lung disease events from April 2014. Events prior to these dates were not adjudicated and were identified by clinical review of AEs. For malignancies, central histopathological review of AEs was initiated in July 2009, with events adjudicated from February 2014. Events prior to this were subsequently reviewed and adjudicated. Data for herpes zoster reflect AEs reported using any preferred term including “Herpes zoster”. Database lock: March 2, 2017
  2. AE adverse event, BID twice daily, CI confidence interval, csDMARD conventional synthetic disease-modifying antirheumatic drug, IR incidence rate, MACE major adverse cardiovascular event, MTX methotrexate, NMSC non-melanoma skin cancer, QD once daily
  3. aFemale patients only
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Arthritis Research & Therapy

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