Table 4.

Cumulative incidence rates of serious infections per 100 patient-years in psoriasis patients with self-reported PsA enrolled in PSOLAR; By cohort

	Ustekinumab	TNF inhibitorsa	Infliximab	Etanercept	Adalimumab	Non-biologic/MTXb	Non-biologic/non-MTXc	Alld
Overall population
N	628	1413	258	481	674	98	208	2401
PY	2009	4101	756	1432	1913	366	694	7244
Serious infections and infestations	1.00 [20]	2.22 [91]	2.12 [16]	2.58 [37]	1.99 [38]	3.01 [11]	2.31 [16]	1.91 [138]
Incident population
N	326	486	64	130	292	98	208	1163
PY	904	1082	125	291	665	366	694	3101
Serious infections and infestations	0.88 [8]	2.50 [27]	0.80 [1]	3.09 [9]	2.56 [17]	3.01 [11]	2.31 [16]	2.00 [62]
Bionaive population
N	56	167	14	72	81	98	208	532
PY	144	419	35	180	204	366	694	1626
Serious infections and infestations	1.39 [2]	1.91 [8]	0.00 [0]	3.33 [6]	0.98 [2]	3.01 [11]	2.31 [16]	2.28 [37]

Data are incidence rate [n]

The biologic user cohort includes patients who are on the cohort defining biologic at entry or start the biologic after entry; previous use or current exposure is allowed for MTX, but not for other systemic immunomodulators

The incidence of adverse events is reported as rate of adverse events per 100 PY. Number of PY is defined as the number of years exposed to the cohort defining medication. Exposure starts from first exposure to a medication on\during registry participation and ends at the earlier of the date of reference end date, initiating another biologic/medication, 90 days after the last dose of the cohort defining treatment, or the date of the annual data cutoff (23AUG2016), whichever is sooner.

PY = number of days exposed / 365.25

MTX methotrexate; PsA psoriatic arthritis; PSOLAR Psoriasis Longitudinal Assessment and Registry; PY patient-years

^aTumor necrosis factor (TNF) inhibitors include infliximab, etanercept, and adalimumab

^bThe non-biologic/MTX cohort includes patients who are receiving MTX at entry or start methotrexate during the registry and haven’t been exposed to other systemic immunomodulators previously or concurrently

^cNon-biologic, non-MTX therapies may include, but are not limited to, cyclosporine, tacrolimus, mycophenolate mofetil, azathioprine, oral corticosteroids, systemic retinoids, psoralen plus ultraviolet (UV), or UVB phototherapy. The non-biologic/non-MTX cohort includes patients who are receiving other systemic immunomodulators (including cyclosporine, tacrolimus, mycophenolate mofetil, other immunomodulators, and oral corticosteroids) at entry or start other immunomodulators after registry and who haven’t been exposed to MTX previously or concurrently; patients who receive only topical and/or phototherapy at/after registry entry are also in this cohort

^dIncludes “Other biologics” group (n = 54); data not shown