Table 3.
Adverse reactions to peanut OIT while on Ketotifen (day 2-week 4)
| Adverse reactions and treatment |
Build-up doses in clinic |
Home doses |
||
|---|---|---|---|---|
| Ketotifen | Placebo | Ketotifen | Placebo | |
| Total no. of doses of OIT, n |
4 |
2 |
108 |
33 |
| Total no. of missed OIT doses, n |
- |
- |
- |
- |
| Total no. of patients reporting symptoms |
3 |
1 |
4 |
2 |
| Total no. of doses with symptoms, n (% of OIT doses) |
3/4 (75%) |
2/2 (100%) |
54/108 (50%) |
27/33 (82%) |
| Anaphylaxis, n (% of OIT doses) |
- |
- |
1/108 (1%) |
1/33 (3%) |
|
Symptoms n, (% of OIT doses) |
Ketotifen |
Placebo |
Ketotifen |
Placebo |
| Gastrointestinal |
3/4 (75%) |
2/2 (100%) |
50/108 (46%) |
27/33 (82%) |
| Cutaneous |
- |
1/2 (50%) |
1/108 (1%) |
6/33 (18%) |
| Lower respiratory |
- |
- |
6/108 (6%) |
2/33 (6%) |
| Upper respiratory |
- |
- |
2/108 (2%) |
- |
| Oropharyngeal |
- |
- |
1/108 (1%) |
- |
| Cardiovascular |
- |
- |
- |
- |
| Other |
- |
- |
14/108 (13%)B |
2/33 (6%)B |
|
Treatment n, (% of OIT doses) |
Ketotifen |
Placebo |
Ketotifen |
Placebo |
| Epinephrine |
- |
- |
- |
1/33 (3%) |
| Diphenhydramine |
- |
- |
1/108 (1%) |
1/33 (3%) |
| Cetirizine** |
1/4 (25%) |
- |
7/108 (6%) |
5/33 (15%) |
| Prednisone |
- |
- |
- |
1/33 (3%) |
| Salbutamol or other inhaled medication | - | - | 1/108 (1%) | - |
BOther reported symptoms included: fever, headache, fatigue, pallor.
**Other second generation antihistamine.