ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.
The data described below reflect exposure to Taclonex® Ointment in 2448 patients, including 1992 exposed for 4 weeks, and 289 exposed for 8 weeks. In the trials that included assessment of the effects of Taclonex® Ointment on calcium metabolism, such testing was done after 4 weeks of treatment. The effects of Taclonex® Ointment on calcium metabolism following treatment durations of longer than 4 weeks are not known (See PRECAUTIONS). The effects of Taclonex® Ointment on the HPA axis following treatment durations of longer than 4 weeks have not been adequately studied. Taclonex® Ointment was studied primarily in placebo- and active-controlled trials (N = 1176, and N = 1272, respectively). The population was 15-97 years old, 61% males and 39% females, mostly white (97%) and had a baseline disease severity ranging from mild to very severe. Most patients received once daily application, and the median weekly dose was 24.5 g.
The percentage of subjects reporting at least one adverse event was 27.1% in the Taclonex® Ointment group, 33.0% in the calcipotriene group, 28.3% in the betamethasone group, and 33.4% in the vehicle group.
Adverse Events Reported by ≥ 1% of Subjects by Preferred Term |
Taclonex®
Ointment
N = 2448 |
Calcipotriene
N = 3197 |
Betamethasone
dipropionate
N = 1164 |
Vehicle
N = 470 |
| Any Adverse Event | 663 (27.1) | 1055 (33.0) | 329 (28.3) | 157 (33.4) |
| Preferred Term | # of subjects (%) |
| Pruritus | 75 (3.1) | 183 (5.7) | 38 (3.3) | 43 (9.1) |
| Headache | 69 (2.8) | 75 (2.3) | 44 (3.8) | 12 (2.6) |
| Nasopharyngitis | 56 (2.3) | 77 (2.4) | 34 (2.9) | 9 (1.9) |
| Psoriasis | 30 (1.2) | 47 (1.5) | 14 (1.2) | 5 (1.1) |
| Rash scaly | 30 (1.2) | 40 (1.3) | 0 (0.0) | 1 (0.2) |
| Influenza | 23 (0.9) | 34 (1.1) | 14 (1.2) | 6 (1.3) |
| Upper respiratory tract infection | 20 (0.8) | 19 (0.6) | 12 (1.0) | 3 (0.6) |
| Erythema | 15 (0.6) | 54 (1.7) | 3 (0.3) | 5 (1.1) |
| Application site pruritus | 13 (0.5) | 24 (0.8) | 10 (0.9) | 6 (1.3) |
| Skin irritation | 11 (0.4) | 60 (1.9) | 8 (0.7) | 5 (1.1) |
| Pain | 7 (0.3) | 12 (0.4) | 3 (0.3) | 5 (1.1) |
| Burning sensation | 6 (0.2) | 30 (0.9) | 3 (0.3) | 6 (1.3) |
A lesional/perilesional adverse event was generally defined as an adverse event located ≤ 2 cm from the lesional border.
Lesional/Perilesional Adverse Events Reported by ≥ 1% of Subjects |
Taclonex ®
Ointment
N = 2448 |
Calcipotriene
N = 3197 |
Betamethasone
dipropionate
N = 1164 |
Vehicle
N = 470 |
| Any Adverse Event | 213 (8.7) | 419 (13.1) | 85 (7.3) | 76 (16.2) |
| Preferred Term | # of subjects (%) |
| Pruritus | 69 (2.8) | 170 (5.3) | 31 (2.7) | 41 (8.7) |
| Rash scaly | 29 (1.2) | 38 (1.2) | 0 (0.0) | 0 (0.0) |
| Application site pruritus | 12 (0.5) | 24 (0.8) | 10 (0.9) | 6 (1.3) |
| Erythema | 9 (0.4) | 36 (1.1) | 2 (0.2) | 4 (0.9) |
| Skin irritation | 9 (0.4) | 51 (1.6) | 8 (0.7) | 5 (1.1) |
| Burning sensation | 6 (0.2) | 25 (0.8) | 3 (0.3) | 5 (1.1) |
For subjects who reported lesional/perilesional adverse events, the median time to onset was 7 days for Taclonex® Ointment, 7 days for calcipotriene, 5 days for betamethasone dipropionate, and 3 days for vehicle.
Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence, folliculitis, rash papular, rash pustular, and skin hypopigmentation. Skin atrophy, telangiectasia and skin hyperpigmentation were reported infrequently (0.1%).
In a separate study, patients (N = 207) with at least moderate disease severity were given Taclonex® Ointment intermittently on an “as needed” basis for up to 52 weeks. The median use was 15.4 g per week. The effects of Taclonex® Ointment on calcium metabolism were not studied and the effects on the HPA axis were not adequately studied. The following adverse reactions were reported by 1% or more of the patients: pruritus (7.2%), psoriasis (3.4%), skin atrophy (1.9%), folliculitis (1.4%), burning sensation (1.4%), skin depigmentation (1.4%), ecchymosis (1.0%), erythema (1.0%) and hand dermatitis (1.0%). One case of a serious flare-up of psoriasis was reported.
Development of pustular psoriasis has been reported as an adverse reaction during and following use of Taclonex® Ointment.
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