TABLE 2.
Studies on infection risk of tumor necrosis factor alpha inhibitors for psoriasis
| Study, year/medication | Patient demographics | Medication, dosage | Indication | Outcome/ type of infection, n (%) |
|---|---|---|---|---|
| TNF‐α inhibitors | ||||
| Adalimumab | ||||
| Yiu et al 35 |
n = 3271 Mean age = 44.7 y Female = 1323 (40.4%) |
Unknown | Psoriasis | N (incidence rate per 1000 person‐years): all serious infection: 108 (13.78), lower respiratory infection: 31 (3.96), skin and soft tissue infection: 19 (2.42) |
| Menter et al 36 |
n = 814 Mean age = 44.1 y Male = 546 (67.1%) |
80 mg at week 0, followed by 40 mg every other week | Psoriasis | All infections: 235 (62.2%), serious infection: 5 (0.6%), URI: 59 (7.2%), opportunistic infection (excluding tuberculosis): 1, tuberculosis: 1 |
| Kalb et al 37 |
n = 2675 Mean age = 47.6 y Male = 1505 (56.3%) |
Unknown | Psoriasis | Incidence rate per 100 patient‐years: serious infection: 1.97 |
| Dommasch et al 15 |
n = 7181 Mean age = 46.10 y Male = 4061 (56.6%) |
Unknown | Psoriasis | Rate compared with methotrexate, HR: overall serious infection: HR, 1.08; 95% CI, 0.88‐1.33, bacteremia/sepsis: HR, 1.06; 95% CI, 0.66‐1.68, cellulitis/soft‐tissue infection: HR, 1.34; 95% CI, 0.95‐1.89, Meningitis/encephalitis: HR, 0.78; 95% CI, 0.10‐6.28, pneumonia: HR, 0.94; 95% CI, 0.68‐1.31, pyelonephritis: HR, 1.11; 95% CI, 0.27‐4.51, septic arthritis/osteomyelitis: HR, 0.78; 95% CI, 0.25‐2.19 |
| Mease et al 38 |
n = 106 Mean age = 47.4 y Female = 50 (47%) |
40 mg every 2 wk | Psoriatic arthritis | Nasopharyngitis: 10.0%, URI: 8.0%, serious infection (herpes simplex and streptococcal pyoderma): 1.0% |
| Reich et al 39 |
n = 248 Mean age = 43.2 y Male = 170 (68.5%) |
80 mg at week 0, then 40 mg at week 1, and every 2 wk through week 23 | Psoriasis | Nasopharyngitis: 34 (13.7%), URI: 10 (4.0%), all infections: 87 (35.1%), requiring treatment: 29 (11.7%), serious infection: 3 (1.2%) |
| Blauvelt et al 40 |
n = 334 Mean age = 42.9 y Male = 249 (74.6%) |
80 mg week 0, 40 mg week 1, then 40 mg every 2 wk through week 46 | Psoriasis | Nasopharyngitis: 74 (22.2%), URI: 42 (12.6%), all infections: 167 (50.2%), infections requiring treatment: 60 (18.0%), serious infection: 3 (0.9%) |
| Saurat et al 26 |
n = 108 Mean age = 42.9 y Male = 64.8% |
80 mg at week 0, then 40 mg every other week | Psoriasis | Serious infection: 0, nonserious infection: 51 (47.7%), nasopharyngitis: 30 (28.0%), viral infection: 0 |
| Etanercept | ||||
| Yiu et al 35 |
n = 1325 Mean age = 45.5 y Female = 565 (41.8%) |
Unknown | Psoriasis | N (incidence rate per 1000 person‐years): serious infection: 50 (14.2), lower respiratory infection: 10 (5.5), skin and soft tissue infection: 18 (5.5) |
| Mease et al 41 |
n = 30 Median age = 46.0 y Age range = 30‐70 y Male = 16 (53%) |
25 mg twice weekly | Psoriasis/psoriatic arthritis | URI: 8 (27%), pharyngitis: 8 (27%), sinusitis: 3 (10%), influenza syndrome: 0 |
| Kalb et al 37 |
n = 1854 Mean age = 48.7 y Male = 1038 (56.0%) |
Unknown | Psoriasis | Incidence rate per 100 patient‐years: serious infection: 1.47 |
| Langley et al (FIXTURE) 42 |
n = 326 Mean age = 43.8 y Male = 232 (71.2%) |
50 mg twice weekly for 12 wk, then once weekly | Psoriasis | N (incidence rate per 100 subject‐years): Infections and infestations: 170 (91.4), nasopharyngitis: 86 (35.7), URI 18 (6.4) |
| Van de Kerkhof et al 43 |
n = 323 Mean age = 43.8 y Male = 229 (70.9%) |
Unknown | Psoriasis | Exposure‐adjusted incidence rates per 100 subject‐years of all infections: 93.7 |
| Dommasch et al 15 |
n = 7102 Mean age = 45.45 Male = 3903 (55.0%) |
Unknown | Psoriasis | Rate compared with methotrexate, HR: overall serious infection: HR, 0.75; 95% CI, 0.61‐0.93, bacteremia/sepsis: HR, 0.51; 95% CI, 0.32‐0.82, cellulitis/soft‐tissue infection: HR, 1.16; 95% CI, 0.82‐1.65, pneumonia: HR, 0.94; 95% CI, 0.68‐1.31, pyelonephritis: HR, 0.68; 95% CI, 0.20‐2.34, septic arthritis/osteomyelitis: HR, 1.61; 95% CI, 0.36‐7.16 |
| Infliximab | ||||
| Yiu et al 44 |
n = 422 Mean age = 46.6 y Male = 159 (37.7%) |
Unknown | Psoriasis | Rate per 1000 person‐years of all serious infections: 47.82, lower respiratory infection: 11.69 |
| Gottlieb et al 45 |
n = 33 Age range = 21‐69 y |
3 groups: placebo or 5 mg/kg or 10 mg/kg at weeks 0, 2 and 6 | Psoriasis | All infections (excluding URI): 7 patients (21%) |
| Reich et al 46 |
n = 301 Mean age = 42.6 y Female = 94 (31%) |
5 mg/kg at weeks 0, 2, 6, and 14 | Psoriasis | All infections: 125 (42.0%), URI: 46 (15.0%), serious infection: 3 (1.0%) |
| Menter et al 47 |
n = 313 Mean age 43.4 y Male = 65.8% |
3 mg/kg at weeks 0, 2, and 6 | Psoriasis | Patients with ≥1 infection: 106 (33.9%), URI: 50 (16%) |
| Menter et al 47 |
n = 314 Mean age = 65.8 y Male = 65% |
5 mg/kg at weeks 0, 2, 6, and 14 | Psoriasis | Patients with ≥1 infection: 97 (30.9%), URI: 42 (13.4%) |
| Kalb et al 37 |
n = 1151 Mean age = 48.5 y Male = 655 (56.9%) |
Unknown | Psoriasis | Incidence rate of serious infection per 100 patient‐years: 2.49 |
| Dommasch et al 15 |
n = 408 Mean age = 50.20 y Male = 202 (49.5%) |
Unknown | Psoriasis | Rate compared with methotrexate, HR: overall serious infection: HR, 1.47; 95% CI, 0.75‐2.87, bacteremia/sepsis: HR, 1.30; 95% CI, 0.19‐8.63, cellulitis/soft‐tissue infection: HR, 1.76; 95% CI, 0.55‐5.63, pneumonia: HR, 0.80; 95% CI, 0.29‐2.24, pyelonephritis: HR, 0.68; 95% CI, 0.20‐2.34 |
| Certolizumab | ||||
| Blauvelt et al 48 |
n = 351 Mean age = 46.1 y Male = 238 (67.8%) |
200 mg every 2 wk | Psoriasis | [Incidence rate]: Infections and infestations: 108 (30.9) [121.6], serious infections: 0 |
| Blauvelt et al 48 |
n = 342 Mean age = 45.2 y Male = 210 (61.4%) |
400 mg every 2 wk | Psoriasis | [Incidence rate]: Infections and infestations: 124 (36.3) [146.6], serious infections: 2 (0.6) [1.9] |
Abbreviations: CI, confidence interval; HR, hazard ratio; URI, upper respiratory infection.