Table 3.
Laboratory abnormalities in the Overall plus P3b/4 [2020] Cohort
| PD tofacitinib 5 mg BID [N = 202] | PD tofacitinib 10 mg BID [N = 955] | Tofacitinib All [N = 1157] | |
|---|---|---|---|
| Creatine kinase elevation, n [%] | 30 [14.9] | 108 [11.7] | 138 [12.3] |
| IR [95% CI]a | 4.16 [2.81–5.94] | 5.39 [4.42–6.50] | 5.06 [4.25–5.98] |
| Discontinuations due to creatine kinase elevation, n [%]b | 1 [3.3] | 2 [1.9] | 3 [2.2] |
| Anemia, n [%] IR [95% CI]c |
12 [5.9] 1.55 [0.80–2.71] |
66 [6.9] 3.06 [2.37–3.89] |
78 [6.7] 2.66[2.10–3.32] |
| Discontinuations due to anaemia, n [%]b | 1 [8.3] | 5 [7.2] | 6 [7.4] |
| Lymphopenia, n [%] IR [95% CI]d |
12 [5.9] 1.53 [0.79–2.68] |
32 [3.4] 1.43 [0.98–2.02] |
44 [3.8] 1.46 [1.06–1.96] |
| Discontinuations due to lymphopaenia, n [%]b | 2 [16.7] | 8 [25.0] | 10[22.7] |
| Neutropaenia, n [%] IR [95% CI]e |
5 [2.5] 0.63 [0.20–1.47] |
5 [0.5] 0.22 [0.07–0.51] |
10 [0.9] 0.33 [0.16–0.60] |
| Discontinuations due to neutropaenia, n [%]b | 0 [0.0] | 1 [20.0] | 1 [10.0] |
| Acute renal failure, n [%] IR [95% CI]c |
1 [0.5] 0.12 [0.00–0.69] |
9 [0.9] 0.40 [0.18–0.76] |
10 [0.9] 0.33 [0.16–0.60] |
| Discontinuations due to acute renal failure, n [%]b | 0 [0.0] | 1 [11.1] | 1 [10.0] |
| Rhabdomyolysis, n [%] IR [95% CI]c |
0 [0.0] 0.00 [0.00–0.46] |
0 [0.0] 0.00 [0.00–0.16] |
0 [0.0] 0.00 [0.00–0.12] |
| Discontinuations due to rhabdomyolysis, n [%]b | 0 [0.0] | 0 [0.0] | 0 [0.0] |
aCreatine kinase elevation included any event coded to the MedDRA preferred term blood creatine phosphokinase increased; Phase 2 study data were not included in evaluation of creatine kinase elevation; N = 922 and N = 1124 for the PD tofacitinib 10 mg BID and tofacitinib all groups, respectively.
bFor discontinuations due to laboratory abnormalities, proportions were calculated based on the number of patients with an abnormality in a treatment group.
cLaboratory abnormalities of anaemia, acute renal failure and rhabdomyolysis were analysed based on events coded to the SMQs of haematopoietic erythropaenia, acute renal failure and rhabdomyolysis/myopathy, respectively.
dLymphopaenia included any event coded to the preferred terms lymphopaenia and lymphocytopaenia neonatal, B lymphocyte count decreased, lymphocyte count decreased or T-lymphocyte count decreased.
eNeutropaenia included any event coded to the higher-level term neutropaenia, or the preferred terms granulocyte count decreased or neutrophil count decreased.
BID, twice daily; CI, confidence interval; IR, incidence rate [unique patients with events/100 PY of exposure]; MedDRA, Medical Dictionary for Regulatory Activities; N, number of patients treated in the treatment group; n, number of unique patients in each category; PD, predominant dose; PY, patient-years; SMQ, Standardized MedDRA Query.