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Table 4 Cumulative incidence rates of serious infections per 100 patient-years in psoriasis patients with self-reported PsA enrolled in PSOLAR; By cohort

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

 

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]

  1. Data are incidence rate [n]
  2. 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
  3. 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.
  4. PY = number of days exposed / 365.25
  5. MTX methotrexate; PsA psoriatic arthritis; PSOLAR Psoriasis Longitudinal Assessment and Registry; PY patient-years
  6. aTumor necrosis factor (TNF) inhibitors include infliximab, etanercept, and adalimumab
  7. 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
  8. 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
  9. dIncludes “Other biologics” group (n = 54); data not shown