Table 3.
Adverse Events Associated with JAK Inhibitors
| Trial | Percent of Patients Reporting TEAEs | Frequency of Serious Adverse Events | Adverse Events | Frequency of Adverse Events | Rate of Discontinuation | |
|---|---|---|---|---|---|---|
| Topical | ||||||
| Delgocitinib | Nakagawa et al.34 Pediatric | 41.7% | 0% | Nasopharyngitis | 0.25% (17.6%) 0.5% (20.6%) Vehicle (8.6%) |
4.9% |
| Impetigo | 0.25% (5.9%) 0.5% (2.9%) Vehicle (8.6%) |
|||||
| Urticaria | 0.25% (5.9%) 0.5% (0%) Vehicle (0%) |
|||||
| Nakagawa et al.33 Adult at the end of 4 weeks |
18.4% | 0% | Nasopharyngitis | 0.5% (5.7%) Placebo (3.8%) |
2.5% | |
| Kaposi varicelliform eruption | 0.5% (1.9%) Placebo (0%) |
|||||
| Dental carries | 0.5% (1.9%) Placebo (0%) |
|||||
| Ruxolitinib | Kim et al.36 | 30.4% | 0% | Application site pain | 0.1% Triamcinolone BID (0%) 0.15% (2.0%) 0.5% (0%) 1.5% (3.9%) 1.5 BID (2.0%) Vehicle (3.8%) |
N/A |
| Nasopharyngitis | 0.1% Triamcinolone BID (0%) 0.15% (5.9%) 0.5% (2.0%) 1.5% (7.8%) 1.5% BID (4.0%) Vehicle (7.7%) |
|||||
| TRuE-AD138 | N/A | N/A | N/A | N/A | N/A | |
| TRuE-AD238 | N/A | N/A | N/A | N/A | N/A | |
| Tofacitinib | Bissonnette et al.41 | 43.5% | 0% | Infections (mostly nasopharyngitis) | 2% (8.7%) Vehicle (4.3%) |
5.8% |
| CPK increase | 2% (0%) Vehicle (4.3%) |
|||||
| Contact dermatitis | 2% (0%) Vehicle (4.3%) |
|||||
| Headache | 2% (1.4%) Vehicle (2.9%) |
|||||
| Oral | ||||||
| Abrocitinib | Gooderham, et al.42 | 68.9% | 3.4% | Gastrointestinal disorders | 10 mg (8.2%) 30 mg (9.8%) 100 mg (10.7%) 200 mg (21.8%) Placebo (7.1%) |
41.2% |
| Diarrhea | 10 mg (6.1%) 30 mg (2.0%) 100 mg (1.8%) 200 mg (9.1%) Placebo (1.8%) |
|||||
| Nausea | 10 mg (6.1%) 30 mg (5.9%) 100 mg (1.8%) 200 mg (14.5%) Placebo (1.8%) |
|||||
| Infections and infestations | 10 mg (46.9%) 30 mg (37.3%) 100 mg (42.9%) 200 mg (41.8%) Placebo (23.2%) |
|||||
| JADE MONO-145 | N/A | 3.0% | Short-lasting nausea | 100 mg (9.0%) 200 mg (20.9%) Placebo (N/A) |
6.5% | |
| Headaches | 100 mg (7.7%) 200 mg (9.7%) Placebo (N/A) |
|||||
| Nasopharyngitis | 100 mg (14.7%) 200 mg (11.7%) Placebo (N/A) |
|||||
| Silverberg et al.46 JADE MONO-2 |
62.1% | 2.1% | Nausea | 100 mg (7.6%) 200 mg (14.2%) Placebo (2.6%) |
15.6% | |
| Nasopharyngitis | 100 mg (12.7%) 200 mg (7.7%) Placebo (6.4%) |
|||||
| Headache | 100 mg (5.7%) 200 mg (7.7%) Placebo (2.6%) |
|||||
| Thrombocytopenia | 100 mg (0%) 200 mg (3.2%) Placebo (0%) |
|||||
| Baricitinib | Guttman-Yassky et al.48 | 54.8% | 0.8% | Headaches | 2 mg + TCS (5%) 4 mg + TCS (13%) Placebo (0%) |
31.45% |
| CPK increase | 2 mg + TCS (3%) 4 mg + TCS (13%) Placebo (0%) |
|||||
| Nasopharyngitis | 2 mg + TCS (3%) 4 mg + TCS (8%) Placebo (2%) |
|||||
| Simpson et al.50 BREEZE-AD1 |
55.8% | 2.7% | Nasopharyngitis | 1 mg (17.3%) 2 mg (9.8%) 4 mg (9.6%) Placebo (10.4%) |
7.9% | |
| URIs | 1 mg (0.8%) 2 mg (2.4%) 4 mg (3.2%) Placebo (2.4%) |
|||||
| CPK increase | 1 mg (0.8%) 2 mg (0.8%) 4 mg (3.2%) Placebo (0.8%) |
|||||
| Headaches | 1 mg (5.5%) 2 mg (11.4%) 4 mg (8.0%) Placebo (6.4%) |
|||||
| Simpson et al.50 BREEZE-AD2 |
55.4% | 3.8% | Nasopharyngitis | 1 mg (10.5%) 2 mg (13.0%) 4 mg (8.1%) Placebo (12.3%) |
7.3% | |
| URIs | 1 mg (4.8%) 2 mg (4.1%) 4 mg (3.3%) Placebo (2.0%) |
|||||
| CPK increase | 1 mg (3.2%) 2 mg (0.8%) 4 mg (5.7%) Placebo (0.4%) |
|||||
| Headaches | 1 mg (4.8%) 2 mg (7.3%) 4 mg (8.9%) Placebo (2.0%) |
|||||
| BREEZE-AD451 | N/A | N/A | Nasopharyngitis | N/A | N/A | |
| Headache | N/A | |||||
| Influenza | N/A | |||||
| Gusacitinib (ASN002) | Bissonnette et al52 | N/A | 2.8% | Headache | 20 mg (11%) 40 mg (44%) 80 mg (22%) Placebo (33%) |
N/A |
| Nausea | 20 mg (0%) 40 mg (11%) 80 mg (44%) Placebo (22%) |
|||||
| Nasopharyngitis | 20 mg (22%) 40 mg (11%) 80 mg (0%) Placebo (11%) |
|||||
| Diarrhea | 20 mg (0%) 40 mg (11%) 80 mg (22%) Placebo (11%) |
|||||
| Back pain | 20 mg (0%) 40 mg (22%) 80 mg (0%) Placebo (0%) |
|||||
| Upadacitinib | Guttman-Yassky, et al.53 | 72.9% | 2.4% | URI | 7.5 mg (17%) 15 mg (12%) 30 mg (12%) Placebo (10%) |
24% |
| Worsening AD | 7.5 mg (14%) 15 mg (4.8%) 30 mg (9.5%) Placebo (5%) |
|||||
| Acne | 7.5 mg (9.5%) 15 mg (4.8%) 30 mg (14%) Placebo (2.5%) |
|||||
| Headache | 7.5 mg (7.1%) 15 mg (7.1%) 30 mg (9.5%) Placebo (2.5%) |
|||||
| Neutropenia | 7.5 mg (2.4%) 15 mg (4.8%) 30 mg (4.8%) Placebo (0%) |
|||||
Abbreviations: AD, atopic dermatitis; BID, twice daily; CPK, creatinine phosphokinase; mg, milligram; N/A, not available; TCS, topical corticosteroid; TEAE, treatment emergent adverse event; URI, upper respiratory infection.