Table 6.

IR per 100,000 person-years and rate ratio of lymphoma and CTCL by cumulative dose of active substance for single use of topical tacrolimus and topical pimecrolimus versus moderate- to high-potency topical corticosteroids in adults

Study outcome and exposure	Person-years	Number of events	IR	Adjusteda IRR (95% CI)
Topical tacrolimus
Any lymphoma
Topical corticosteroids	777,075	199	25.6	1.00
Topical tacrolimus (g)b
≤0.05	122,230	47	38.5	1.40 (1.00–1.97)
>0.05–0.10	40,436	12	29.7	1.06 (0.59–1.92)
>0.10	27,746	19	68.5	2.27 (1.39–3.69)
CTCL
Topical corticosteroids	777,075	24	3.1	1.00
Topical tacrolimus (g)b
≤0.05	122,230	8	6.5	1.81 (0.71–4.63)
>0.05–0.10	40,436	4	9.9	3.39 (1.22–9.47)
>0.10	27,746	6	21.6	6.19 (2.28–16.79)
Topical pimecrolimus
Any lymphoma
Topical corticosteroids	680,797	147	21.6	1.00
Topical pimecrolimus (g)c
≤0.5	125,352	24	19.1	0.89 (0.57–1.37)
>0.5–1.0	20,248	10	49.4	2.25 (1.19–4.26)
>1.0	13,930	9	64.6	2.55 (1.27–5.12)
CTCL
Topical corticosteroids	680,797	11	1.6	1.00
Topical pimecrolimus (g)c
≤0.5	125,352	1	0.8	0.52 (0.07–3.93)
>0.5–1.0	20,248	1	4.9	3.21 (0.29–35.73)
>1.0	13,930	1	7.2	4.46 (0.54–36.58)

Notes: PHARMO, PHARMO Database Network (the Netherlands). Topical corticosteroids refer to moderate- to high-potency topical corticosteroids.

^aAdjusted by study database; deciles of propensity scores; sex; and, in PHARMO and Sweden, type of prescriber of first prescription (dermatologist and nondermatologist).

^bA cumulative dose of 0.10 g of active substance corresponds to 5.6 tubes of 60 g tacrolimus 0.03% ointment (1.7 tubes of 60 g tacrolimus 0.1% ointment).

^cA cumulative dose of 1 g of active substance corresponds to 1.7 tubes of 60 g pimecrolimus 1% ointment.

Abbreviations: CI, confidence interval; CTCL, cutaneous T-cell lymphoma; IR, incidence rate; IRR, IR ratio.