Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologics

Ritchlin, Christopher T.; Stahle, Mona; Poulin, Yves; Bagel, Jerry; Chakravarty, Soumya D.; Kafka, Shelly; Srivastava, Bhaskar; Langholff, Wayne; Gottlieb, Alice B.

doi:10.1186/s41927-019-0094-3

Table 5 Cumulative incidence of serious infections per 100 patient-years by type of infection in psoriasis patients with self-reported PsA enrolled in PSOLAR; Overall population

From: Serious infections in patients with self-reported psoriatic arthritis from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) treated with biologics

	Ustekinumab (N = 2009 PY)	TNF inhibitors^a (N = 4010 PY)	Infliximab (N = 756 PY)	Etanercept (N = 1432 PY)	Adalimumab (N = 1913 PY)	Non-biologic /MTX^b (N = 366 PY)	Non-biologic /non-MTX^c (N = 694 PY)	All^d (N = 7244 PY)
Serious infections^e	1.00 [20]	2.22 [91]	2.12 [16]	2.58 [37]	1.99 [38]	3.01 [11]	2.31 [16]	1.91 [138]
Appendicitis, perforated	0.05 [1]	0.05 [2]	0.00 [0]	0.00 [0]	0.10 [2]	0.00 [0]	0.14 [1]	0.06 [4]
Arthritis, infectious	0.00 [0]	0.02 [1]	0.00 [0]	0.07 [1]	0.00 [0]	0.00 [0]	0.14 [1]	0.03 [2]
Cellulitis	0.05 [1]	0.54 [22]	0.66 [5]	0.84 [12]	0.26 [5]	0.55 [2]	0.00 [0]	0.35 [25]
Clostridium difficile colitis	0.00 [0]	0.00 [0]	0.00 [0]	0.00 [0]	0.00 [0]	0.27 [1]	0.29 [2]	0.04 [3]
Clostridium difficile infection	0.00 [0]	0.02 [10]	0.13 [1]	0.00 [0]	0.00 [0]	0.27 [1]	0.00 [0]	0.03 [2]
Device-related infection	0.00 [0]	0.07 [3]	0.13 [1]	0.07 [1]	0.05 [1]	0.00 [0]	0.00 [0]	0.04 [3]
Diverticulitis	0.05 [1]	0.17 [7]	0.00 [0]	0.35 [5]	0.10 [2]	0.00 [0]	0.14 [1]	0.12 [9]
Gastroenteritis	0.00 [0]	0.07 [3]	0.00 [0]	0.07 [1]	0.10 [2]	0.27 [1]	0.14 [1]	0.07 [5]
Herpes zoster	0.00 [0]	0.07 [3]	0.00 [0]	0.14 [2]	0.05 [1]	0.00 [0]	0.00 [0]	0.04 [3]
Pneumonia	0.15 [3]	0.41 [17]	0.26 [2]	0.49 [7]	0.42 [8]	0.55 [2]	0.29 [2]	0.33 [24]
Postoperative wound infection	0.00 [0]	0.00 [0]	0.00 [0]	0.00 [0]	0.00 [0]	0.27 [1]	0.14 [1]	0.03 [2]
Acute pyelonephritis	0.00 [0]	0.02 [1]	0.00 [0]	0.00 [0]	0.05 [1]	0.00 [0]	0.14 [1]	0.03 [2]
Sepsis	0.05 [1]	0.05 [2]	0.00 [0]	0.07 [1]	0.05 [1]	0.00 [0]	0.00 [0]	0.04 [3]
Septic shock	0.00 [0]	0.05 [2]	0.13 [1]	0.07 [1]	0.00 [0]	0.27 [1]	0.00 [0]	0.04 [3]
Urinary tract infection	0.00 [0]	0.07 [3]	0.00 [0]	0.14 [2]	0.05 [1]	0.00 [0]	0.00 [0]	0.04 [3]
Urosepsis	0.05 [1]	0.00 [0]	0.00 [0]	0.00 [0]	0.00 [0]	0.00 [0]	0.29 [2]	0.04 [3]

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
PY = number of days exposed / 365.25
The following opportunistic infections (OIs) were reported (incidence rate [n]): coccidioidomycosis (ustekinumab: 0.05 [1]); herpes zoster (etanercept: 0.14 [2]; adalimumab (0.05 [1]); herpes zoster disseminated (infliximab: 0.13 [1]); infectious mononucleosis (infliximab: 0.13 [1]); pneumonia legionella (adalimumab: 0.05 [1]). No OIs were reported in the non-biologics/MTX and non-biologics/non-MTX groups
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
^eSerious infections (SIs) occurred at least 2 times across treatment cohorts. SIs as classified by the investigator are included in this analysis. The incidence of SIs is reported as rate of SIs 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

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