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Table 1 Patients with all-cause treatment-emergent AEs

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

 

Tofacitinib 5 mg BID (n = 1123)

Tofacitinib 10 mg BID (n = 3358)

All tofacitinib (n = 4481)

AEs, n (%) [IRs; patients with events per 100 patient-years; 95% CI]

 AEs

1015 (90.4)

[98.69; 92.71, 104.96]

3021 (90.0)

[118.54; 114.35, 122.84]

4036 (90.1)

[112.83; 109.38, 116.37]

 SAEs

346 (30.8)

[8.16; 7.31, 9.07]

997 (29.7)

[9.37; 8.80, 9.98]

1343 (30.0)

[9.03; 8.55, 9.53]

 Discontinued due to AEs

315 (28.0)

[6.67; 5.95, 7.45]

805 (24.0)

[6.83; 6.36, 7.32]

1120 (25.0)

[6.78; 6.39, 7.20]

Dose reduction or temporary discontinuation due to AEs

518 (46.1)

[16.85; 15.43, 18.36]

1329 (39.6)

[15.70; 14.87, 16.57]

1847 (41.2)

[16.01; 15.29, 16.76]

 Dose reduction only

75 (14.5)

86 (6.5)

161 (8.7)

 Temporary discontinuation only

372 (71.8)

1147 (86.3)

1519 (82.2)

 Dose reduction and temporary discontinuation

71 (13.7)

96 (7.2)

167 (9.0)

  Permanent discontinuationa

275 (53.1)

615 (46.3)

890 (48.2)

AEs, n (%) [EAERs; patients with events per 100 patient-years]

Most frequently reported AEs by SOC (≥ 20% in any treatment group) and within-SOC preferred term (≥ 5% in any treatment group)

Infections and infestations

738 (65.7)

[15.90]

2299 (68.5)

[20.04]

3037 (67.8)

[18.84]

 Upper respiratory tract infection

228 (20.3)

[4.91]

614 (18.3)

[5.35]

842 (18.8)

[5.22]

 Nasopharyngitis

138 (12.3)

[2.97]

518 (15.4)

[4.51]

656 (14.6)

[4.07]

 Urinary tract infection

166 (14.8)

[3.57]

453 (13.5)

[3.94]

619 (13.8)

[3.84]

 Bronchitis

143 (12.7)

[3.08]

434 (12.9)

[3.78]

577 (12.9)

[3.58]

 Herpes zoster

119 (10.6)

[2.56]

386 (11.5)

[3.36]

505 (11.3)

[3.13]

 Sinusitis

70 (6.2)

[1.50]

242 (7.2)

[2.10]

312 (7.0)

[1.93]

 Influenza

81 (7.2)

[1.74]

199 (5.9)

[1.73]

280 (6.2)

[1.73]

 Pharyngitis

58 (5.2)

[1.24]

148 (4.4)

[1.29]

206 (4.6)

[1.27]

Musculoskeletal and connective tissue disorders

447 (39.8)

[9.63]

1373 (40.9)

[11.96]

1820 (40.6)

[11.29]

 Rheumatoid arthritis

111 (9.9)

[2.39]

309 (9.2)

[2.69]

420 (9.4)

[2.60]

 Back pain

109 (9.7)

[2.34]

301 (9.0)

[2.62]

410 (9.1)

[2.54]

 Arthralgia

88 (7.8)

[1.89]

271 (8.1)

[2.36]

359 (8.0)

[2.22]

 Osteoarthritis

66 (5.9)

[1.42]

196 (5.8)

[1.70]

262 (5.8)

[1.62]

Gastrointestinal disorders

406 (36.2)

[8.74]

1045 (31.1)

[9.10]

1451 (32.4)

[9.00]

 Diarrhea

74 (6.6)

[1.59]

218 (6.5)

[1.90]

292 (6.5)

[1.81]

 Nausea

57 (5.1)

[1.22]

175 (5.2)

[1.52]

232 (5.2)

[1.43]

Investigations

404 (36.0)

[8.70]

1007 (30.0)

[8.77]

1411 (31.5)

[8.75]

 Blood creatine phosphokinase increased

91 (8.1)

[1.96]

249 (7.4)

[2.17]

340 (7.6)

[2.11]

 ALT increased

63 (5.6)

[1.35]

122 (3.6)

[1.06]

185 (4.1)

[1.14]

 Blood creatinine increased

60 (5.3)

[1.29]

116 (3.5)

[1.01]

176 (3.9)

[1.09]

Injury, poisoning, and procedural complications

267 (23.8)

[5.75]

783 (23.3)

[6.82]

1050 (23.4)

[6.51]

 Fall

70 (6.2)

[1.50]

217 (6.5)

[1.89]

287 (6.4)

[1.78]

Nervous system disorders

232 (20.7)

[4.99]

687 (20.5)

[5.98]

919 (20.5)

[5.70]

 Headache

67 (6.0)

[1.44]

203 (6.0)

[1.76]

270 (6.6)

[1.67]

Respiratory, thoracic, and mediastinal disorders

223 (19.9)

[4.80]

671 (20.0)

[5.84]

894 (20.0)

[5.54]

 Cough

65 (5.8)

[1.40]

203 (6.0)

[1.76]

268 (6.0)

[1.66]

  1. Safety analysis set: all patients who received at least one dose of study medication. Database lock: March 2, 2017
  2. AE adverse event, ALT alanine aminotransferase, BID twice daily, CI confidence interval, EAER exposure-adjusted event rate, IR incidence rate, SAE serious adverse event, SOC system organ class
  3. aPatients who had dose reduction or temporary discontinuation due to AEs and eventually discontinued from the study
  4. EAERs represent rates of events/100 patient-years of exposure. 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). Exposure for EAER calculations was 16,113 patient-years for all tofacitinib (4641 patient-years in the 5 mg BID population and 11,472 patient-years in the 10 mg BID population). Data for herpes zoster reflect only AEs reported using preferred term “Herpes zoster”