Table 2.

Incidence rate ranges (events per 100 patient‐years) for safety events of interest reported in randomized controlled trials, observational studies, Pfizer‐commissioned comparison cohorts (Medicare, KPNC) and the tofacitinib clinical trials

	Published RCTsa	Published observational studies	Medicare comparison cohort	KPNC comparison cohort	Tofacitinib allb
Serious infections	0–4·55	0·83–2·62	NA	1·51–2·17	1·68
Herpes zoster	4·75	0·00–3·23	1·11–1·43	0·86–1·03	2·55
Malignancies (excluding NMSC)	0–7·69	0·54–2·9	0·50–1·29	0·75–1·15	1·00
NMSC	0–2·08	0·07–1·89	2·24–5·36	1·14–1·24	0·74
MACE	0–1·16	0·36–4·45c	NA	NA	0·37

KPNC, Kaiser Permanente Northern California; MACE, major adverse cardiovascular events; NA, not available; NMSC, nonmelanoma skin cancer. ^aPublished randomized controlled trial (RCT) data refer to data from the full duration (typically 1 year) of clinical trials of agents other than tofacitinib (secukinumab, ustekinumab, adalimumab, etanercept, infliximab, apremilast and oral methotrexate); they do not include data from long‐term extension phases. ^bIncludes data for combined tofacitinib exposure for up to 3 years in the index and long‐term extension studies. ^cRange cited is for rates where definition of MACE included any death. When cardiovascular death only was included, the upper bound was 2·22 rather than 4·45 events per 100 patient‐years.