Table 2.
Adverse events from month 0 to month 12
| Tapering TNFi (n=47) |
Stable TNFi (n=45) |
|
| Adverse events* | ||
| Upper respiratory tract infections, no | 5 | 14 |
| Diarrhoea, no | 3 | 0 |
| Fracture, no | 3 | 0 |
| Influenza, no | 0 | 3 |
| Urinary tract infection (including pyelonephritis), no | 3 | 1 |
| Patients with adverse events | ||
| 1, no (%) | 10 (21) | 16 (36) |
| ≥2, no (%) | 13 (28) | 15 (33) |
| Adverse events | ||
| Serious†‡, no | 3 | 2 |
| Leading to study discontinuation§, no | 0 | 1 |
| Total, no | 49 | 57 |
*Adverse events occurring with a frequency of 3 or more in at least one of the groups are listed. Additionally, there were three events total of iridocyclitis and joint pain; two events total of abdominal pain, back pain, conjunctivitis, dyspepsia, herpes zoster, hypercholesterolaemia, infections not otherwise specified, liver enzyme elevation, palpitations, skin reaction, upper respiratory tract symptoms and wound infection; one event each of angina pectoris, ankle oedema, ankle sprain, atrioventricular block third degree, borrelia burgdorferi, bursitis, cardiac pacemaker insertion, carotid artery calcification, chest pain, chronic obstructive lung disease, colon polypectomy, depression, fall with syncope, forgetfulness, gastrointestinal bleeding, heart attack, haematuria, incontinence, insect sting allergy, leucopenia, liver cirrhosis, menstruation irregular, nausea, night sweat, nocturia, osteoporosis, otitis media, periodontitis, pneumonia, postoperative infection, pruritus cutaneous, rheumatoid vasculitis, shoulder operation, Sjogren’s syndrome, stomach influenza, syrinx, rupture of tendon, skin biopsy, tinnitus, tiredness, transient cerebral ischaemia, tooth infection and urinary tract pain.
†The serious adverse events were one case of heart attack, one viral infection and one case of fall with syncope in the tapering group; one atrioventricular block third degree and one case of rheumatoid vasculitis in the stable group. The term serious adverse event included any untoward medical occurrence that resulted in death, was immediately life-threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability or incapacity, was a congenital abnormality or birth defect, or was an important medical event that could jeopardise the subject or could require medical intervention to prevent one of the outcomes listed above.
‡There were no cancers, and none of the adverse events led to death.
§Rheumatoid vasculitis.
TNFi, tumour necrosis factor inhibitor.