Table 2.
Summary of infection AEs in ORAL Surveillance
| Patients with events, n (%) | Tofacitinib 5 mg two times per day (N=1455) | Tofacitinib 10 mg two times per day (N=1456) | TNFi (N=1451) |
| Infections and Infestations (MedDRA System Organ Class)* | 1036 (71.2) | 1055 (72.5) | 930 (64.1) |
| Most frequently reported, by MedDRA Preferred Term (≥3% of patients with events in any treatment group)* | |||
| Upper respiratory tract infection | 308 (21.2) | 312 (21.4) | 255 (17.6) |
| Bronchitis | 222 (15.3) | 237 (16.3) | 163 (11.2) |
| Urinary tract infection | 186 (12.8) | 221 (15.2) | 184 (12.7) |
| HZ (non-serious/serious)† | 176 (12.1) | 167 (11.5) | 55 (3.8) |
| Nasopharyngitis | 164 (11.3) | 165 (11.3) | 158 (10.9) |
| Pneumonia | 95 (6.5) | 101 (6.9) | 78 (5.4) |
| Sinusitis | 92 (6.3) | 79 (5.4) | 91 (6.3) |
| Pharyngitis | 86 (5.9) | 79 (5.4) | 75 (5.2) |
| Influenza | 90 (6.2) | 91 (6.3) | 71 (4.9) |
| Latent TB | 87 (6.0) | 67 (4.6) | 91 (6.3) |
| Gastroenteritis | 64 (4.4) | 79 (5.4) | 53 (3.7) |
| Respiratory tract infection | 43 (3.0) | 43 (3.0) | 31 (2.1) |
| Cellulitis | 36 (2.5) | 32 (2.2) | 50 (3.4) |
| SIEs | 141 (9.7) | 169 (11.6) | 119 (8.2) |
| Non-fatal | 135 (9.3) | 156 (10.7) | 115 (7.9) |
| Fatal | 6 (0.4) | 13 (0.9) | 4 (0.3) |
| Patients with 1 SIE | 110 (7.6) | 140 (9.6) | 95 (6.6) |
| Patients with 2 SIEs‡ | 22 (1.5) | 23 (1.6) | 18 (1.2) |
| Patients with 3 SIEs‡ | 7 (0.5) | 2 (0.1) | 5 (0.3) |
| Patients with ≥4 SIEs‡ | 2 (0.1) | 4 (0.3) | 1 (0.1) |
| NSIs | 983 (67.6) | 1003 (68.9) | 882 (60.8) |
| Patients with 1 NSI event | 307 (21.1) | 326 (22.4) | 334 (23.0) |
| Patients with 2 NSI events‡ | 226 (15.5) | 228 (15.7) | 200 (13.8) |
| Patients with 3 NSI events‡ | 160 (11.0) | 135 (9.3) | 117 (8.1) |
| Patients with ≥4 NSI events‡ | 290 (19.9) | 314 (21.6) | 231 (15.9) |
| NSIs excluding all HZ | 954 (65.6) | 968 (66.5) | 870 (60.0) |
| All HZ (non-serious/serious)§ | 180 (12.4) | 178 (12.2) | 58 (4.0) |
| Seriousness | |||
| Non-serious¶ | 170 (94.4) | 161 (90.4) | 56 (96.6) |
| Serious¶ | 10 (5.6) | 17 (9.6) | 2 (3.4) |
| Severity | |||
| Mild¶ | 61 (33.9) | 49 (27.5) | 16 (27.6) |
| Moderate¶ | 110 (61.1) | 116 (65.2) | 40 (69.0) |
| Severe¶ | 9 (5.0) | 13 (7.3) | 2 (3.4) |
| All HZ (non-serious/serious)§ | |||
| Patients with 1 HZ event | 138 (9.5) | 137 (9.4) | 46 (3.2) |
| Patients with 2 HZ events‡ | 33 (2.3) | 35 (2.4) | 11 (0.8) |
| Patients with 3 HZ events‡ | 9 (0.6) | 5 (0.3) | 1 (0.1) |
| Patients with ≥4 HZ events‡ | 0 (0.0) | 1 (0.1) | 0 (0.0) |
| Adjudicated multidermatomal HZ** | 29 (2.0) | 24 (1.7) | 12 (0.8) |
| Adjudicated special interest HZ†† | 17 (1.2) | 17 (1.2) | 4 (0.3) |
| Discontinuation from study drug due to HZ | 6 (0.4) | 12 (0.8) | 2 (0.1) |
| Adjudicated opportunistic infections* | 39 (2.7) | 44 (3.0) | 21 (1.5) |
| HZ adjudicated as an opportunistic infection*,‡‡ | 34 (2.3) | 32 (2.2) | 13 (0.9) |
| TB adjudicated as an opportunistic infection* | 1 (0.1) | 5 (0.3) | 5 (0.3) |
| Adjudicated opportunistic infections excluding HZ and TB | 4 (0.3) | 7 (0.5) | 3 (0.2) |
For patients randomised to the tofacitinib 10 mg two times per day group who had their dose of tofacitinib reduced to 5 mg two times per day, the data collected after patients were switched to tofacitinib 5 mg two times per day were counted in the tofacitinib 10 mg two times per day group.
*Reported elsewhere.13
†Includes the Preferred Term HZ from the clinical database recorded on the AE case report forms.
‡Events were counted as separate events if the event start dates were different.
§Includes HZ adjudicated as opportunistic infections and non-adjudicated HZ events, which included preferred terms of genital HZ, HZ, HZ cutaneous disseminated, HZ disseminated, HZ infection neurological, HZ meningitis, HZ meningoencephalitis, HZ necrotising retinopathy, HZ oticus, HZ pharyngitis, ophthalmic HZ, HZ ophthalmic and HZ multidermatomal, from the clinical database recorded on the AE case report forms.
¶Percentages calculated based on number of patients with HZ adjudicated as opportunistic infections and non-adjudicated HZ events from the clinical database.
**Cases of HZ involving non-adjacent dermatomes or >2 adjacent dermatomes.
††Cases of HZ involving two adjacent dermatomes.
‡‡Cases of multidermatomal HZ and disseminated HZ (diffuse rash (>6 dermatomes)), encephalitis, pneumonia and other organ involvement) were adjudicated as opportunistic infections.
AE, adverse event; HZ, herpes zoster; MedDRA, Medical Dictionary for Regulatory Activities; n, number of patients with events; N, number of evaluable patients; NSI, non-serious infection; SIE, serious infection event; TB, tuberculosis; TNFi, tumour necrosis factor inhibitors.