Table 1.
Rates of upper respiratory infection, influenza, and serious infection in the phase III clinical trials of US FDA-approved biologics for psoriasis
| Medication, year of FDA approval, mechanism of action | Rates of URI (vs. placebo) | Rates of influenza (vs. placebo) | Rates of serious infections (vs. placebo) |
|---|---|---|---|
| Adalimumab, 2002, TNFα inhibitor | REVEAL [7] | REVEAL | REVEAL |
| 7.2% (40 mg) vs. 3.5% (placebo) at week 16 | NR | 0.6% (40 mg) vs. 1% (placebo) at week 16 | |
| CHAMPION [8] | CHAMPION | CHAMPION | |
| 28% (40 mg) vs. 20.8% (placebo) at week 16 for nasopharyngitis | 0% (40 mg) vs. 1.9% (placebo) at week 16 for viral infection | 0% (40 mg) vs. 0% (placebo) at week 16 | |
| Etanercept, 2004 TNFα inhibitor | Tyring et. al. [9] | Tyring et. al. [9] | Tyring et. al. [9] |
| 20.2/100 PY (50 mg) vs. 24.3/100 PY (placebo) through week 96 | NR | 1.2/100 PY (50 mg) vs. 1.5/100 PY (placebo) through week 96 | |
| Papp et al. [10] | Papp et al. [10] | Papp et al. [10] | |
| 13% (50 mg) vs. 13% (25 mg) vs. 13% (placebo) at week 12 | 4% (50 mg) vs. 5% (25 mg) vs. 2% (placebo) at week 12 for “flu syndrome” | NR (< 5% reported in study) | |
| Leonardi et. al. [11] | Leonardi et. al. [11] | Leonardi et. al. [11] | |
| 5% (50 mg BIW) vs. 9% (25 mg BIW) vs. 10% (25 mg QWK) vs. 11% (placebo) at week 12 | NR (< 5% reported in study) | NR (< 5% reported in study) | |
| Infliximab, 2006, TNFα inhibitor | EXPRESS 1 [12] | EXPRESS 1 | EXPRESS 1 |
| 15% (5 mg/kg) vs. 16% (placebo) at week 24 | NR | NR | |
| EXPRESS 2 [13] | EXPRESS 2 | EXPRESS 2 | |
| 16% (3 mg/kg) vs. 13.4% (5 mg/kg) vs. 14% (placebo) at week 14 | NR | NR | |
| Certolizumab, 2018, PEGylated TNFα inhibitor | CIMPASI 1 [14] | CIMPASI 1 | CIMPASI 1 |
| 9.1% (400 mg) vs. 7.4% (200 mg) vs. 5.9% (placebo) at week 16 | NR | 0% (400 mg) vs. 0% (200 mg) vs. 0% (placebo) at week 16 | |
| CIMPASI 2 [14] | CIMPASI 2 | CIMPASI 2 | |
| 5.7% (400 mg) vs. 4.4% (200 mg) vs. 4.1% (placebo) at week 16 | NR | 1.1% (400 mg) vs. 0% (200 mg) vs. 0% (placebo) at week 16 | |
| CIMPACT [28] | CIMPACT | CIMPACT | |
| 3.6% (200 mg) vs. 10.5% (placebo) at week 12 | NR | 0% vs. 0% at week 12 | |
| Ustekinumab, 2009, anti-IL-12/23 | PHOENIX 1 [15] | PHOENIX 1 | PHOENIX 1 |
| 7.1% (45 mg) vs. 6.3% (90 mg) vs. 6.3% (placebo) at week 12 | NR | 0% (45 mg) vs. 0.8% (90 mg) vs. 0.4% (placebo) at week 12 | |
| PHOENIX 2 [16] | PHOENIX 2 | PHOENIX 2 | |
| 4.4% (45 mg) vs. 2.9% (90 mg) vs. 3.4% (placebo) at week 12 | NR | 0% (45 mg) vs. 0.2% (90 mg) vs. 0.5% (placebo) at week 12 | |
| Secukinumab, 2015, anti-IL-17A | ERASURE [17] | ERASURE | ERASURE |
| 3.7% (300 mg) vs. 4.1% (150 mg) 0% (placebo) at week 12 | 2% (300 mg) vs. 1.2% (150 mg) vs. 1.2% (placebo) at week 12 | 1% (300 mg) vs. 0.7% (150 mg) vs. 1.5% (placebo) at week 52 | |
| FIXTURE [17] | FIXTURE | ||
| 2.1% (300 mg) vs. 3.1% (150 mg) vs. 0.9% (placebo) at week 12 | 1.1% (300 mg) vs. 0.6% (150 mg) vs. 0.3% (placebo) at week 52 | ||
| FEATURE [18] | |||
| 5.1% (300 mg) vs. 5.1% (150 mg) vs. 8.5% (placebo) at week 12 for nasopharyngitis | |||
| JUNCTURE [19] | |||
| Sinusitis: 5% (300 mg) vs. 1.6% (150 mg) vs. 0% (placebo); Nasopharyngitis: 31.7% (300 mg) vs. 23% (150 mg) vs. 16.4% (placebo) at week 12 | |||
| Brodalumab, 2017, anti-IL-17 | AMAGINE 1 [20] | AMAGINE 1 | AMAGINE 1 |
| 8.2% (140 mg Q2W) vs. 8.1% (210 mg Q2W) vs. 6.4% (placebo) | NR | 0.9% (140 mg Q2W) vs. 0.5% (210 mg Q2W) vs. 0% (placebo) at week 12 | |
| 4.5% (140 mg Q2W) vs. 1.2% (210 mg Q2W) at week 52 | |||
| AMAGINE 2 [21] | AMAGINE 2 | AMAGINE 2 | |
| NR | NR | NR | |
| AMAGINE 3 [21] | AMAGINE 3 | AMAGINE 3 | |
| NR | NR | NR | |
| Ixekizumab, 2017, anti-IL-17A | UNCOVER 1, 2, 3 (pooled) [22] | UNCOVER 1, 2, 3 (pooled) | UNCOVER 1, 2, 3 (pooled) |
| 3.9% (Q4W) vs. 4.4% (Q2W) vs. 3.5% (placebo) at week 12 | NR | 0.7% (Q4W) vs. 0.4% (Q2W) vs. 0.4% (placebo) at week 12 | |
| 10% (IXE all exposure) at week 60 | 1.4% (IXE all exposure) at week 60 | ||
| Guselkumab, 2017, anti-IL-23 | VOYAGE 1 [23] | VOYAGE 1 | VOYAGE 1 |
| 7.6% (100 mg) vs. 5.2% (placebo) at week 16 | NR | 0% (100 mg) vs. 0% (placebo) at week 16 | |
| VOYAGE 2 [24] | VOYAGE 2 | VOYAGE 2 | |
| 3.2% (100 mg) vs. 4.0% (placebo) at week 16 | NR | 0.2% (100 mg) vs. 0.4% (placebo) at week 16 | |
| Tildrakizumab, 2018, anti-IL-23 | RESURFACE 1 [25] | RESURFACE 1 | RESURFACE 1 |
| 3% (100 mg) vs. 5% (200 mg) vs. 6% (placebo) at week 12 | NR | < 1% (100 mg) vs. < 1% (200 mg) vs. 0% (placebo) at week 12 | |
| RESURFACE 2 [25] | RESURFACE 2 | RESURFACE 2 | |
| 0% (100 mg) vs. 0% (200 mg) vs. 0% (placebo) at week 12 | NR | 0% (100 mg) vs. < 1% (200 mg) vs. 1% (placebo) at week 12 | |
| Risankizumab, 2019, anti-IL-23 | ULTIMMA-1 [26] | ULTIMMA-1 | ULTIMMA-1 |
| Part A: 5.59% (150 mg) vs. 1.96% (placebo) at week 16 | Part A: 6.58% (150 mg) vs. 5.88% (placebo) at week 16 viral upper respiratory infection | Part A: 0.3% (150 mg) vs. 0% (placebo) at week 16 | |
| Part B: 10.10% (150 mg) vs. 8.25% (placebo) at weeks 16–52 | Part B: 13.47% (150 mg) vs. 15.46% (placebo) at weeks 16–52 for viral upper respiratory infection | Part B: 0.7% (150 mg) vs. 1% (placebo) at weeks 16–52 | |
| ULTIMMA-2 [26] | ULTIMMA-2 | ULTIMMA-2 | |
| Part A: 3.74% (150 mg) vs. 2.04% (placebo) at week 16 | Part A: 2.04% (150 mg) 1.02% (placebo) at week 16 for influenza | Part A: 1% (150 mg) vs. 0% (placebo) at week 16 | |
| Part B: 8.25% (150 mg) vs. 9.57% (placebo) at weeks 16–52 | Part B: 1.37% (150 mg) vs. 2.13% (placebo) at weeks 16–52 for influenza | Part B: 0.7% (150 mg) vs. 0% (placebo) at weeks 16–52 | |
| IMMHANCE [27] | IMMHANCE | IMMHANCE | |
| Part A1: 1.47% (150 mg) vs. 5% (placebo) at week 16 | Part A1: 0.74% (150 mg) vs. 1% (placebo) at week 16 | 0% (150 mg) vs. 0% (placebo) at week 16 for viral infection, bronchitis, and bacterial meningitis |
NR not reported, NS not significant, PY patient year