This study was conducted as a non-randomized, unmasked, multi-centered clinical trial. Dogs were client-owned, and written informed consent was obtained prior to completion of any study activities. At the time of enrollment, dogs were are least 12 months of age, and weighed a minimum of 3.0 kg (6.6 lbs) and no more than 80.0 kg (175.9 lbs). The dogs were diagnosed with allergic dermatitis or atopic dermatitis and, per the Veterinarian, needed to receive Apoquel twice daily to manage clinical signs. Dogs with a diagnosed history or current diagnosis of malignant neoplasia, that were intended for breeding, pregnant or lactating, or had received Apoquel within 7 days prior to enrollment could not be enrolled in the study. A single blood sample for a complete blood count and serum biochemistry was collected to ensure dogs did not have any clinically significant clinical pathological abnormalities that would require withdrawal from study.
After enrollment, a minimum of 7 days of oclacitinib maleate chewable tablets were dispensed for administration twice daily at label dose. Dogs may have received up to 14 days if deemed appropriate by the Veterinarian. All doses were administered in the dog’s normal home environment. If additional medications were being administered on the same day as oclacitinib, the chewable tablets were to be administered first, and the owner was to wait a minimum of 30 minutes before any medications, treats, supplements or food was administered.
A 5-minute timer was started when the dog was given access to the chewable tablet(s). The entire dose was offered by placing the tablet(s) in the dog’s usual empty food bowl or in the palm/fingers of the owner’s hand. A single dose may have been comprised of more than one tablet. The tablet(s) was not broken, crumbled or crushed except for breaking a tablet in half as necessary to administer the correct dose (e.g., for dogs that require 0.5 or 1.5 tablets per dose). The owner observed the dog carefully during the whole five-minute period to assess whether the total dose was consumed. When the alarm timer sounded (indicating five minutes had elapsed) the owner recorded whether the dose was completely consumed or not. If the dog consumed the complete dose, it was recorded, and no further assessment was needed. If, while dosing the dog (within the five-minute assessment), the owner observed the dog vomiting, regurgitating or spitting out the tablet, the tablet was re-offered immediately either in the bowl or in the palm/fingers of the owner’s hand. If necessary, a new tablet was offered. If the dose had not been completed consumed within the initial 5 minutes, the owner administered any unconsumed dose (or portion of the dose) to the dog, using either assisted administration (placing the dose in the dog’s mouth or in the back of the dog’s throat and closing the dog’s mouth until the dose has been swallowed) or the dose may have been administered with food, treat or water. This additional offering ensured that the dog received the appropriate treatment for the underlying condition.
Data Summaries:
Data summaries were calculated (SAS/STAT User’s Version 9.4, SAS Institute, Cary, NC). Hypothesis tests were not conducted for this study.
To evaluate overall voluntary acceptance, percentage of acceptance tests across the entire period of the study where the full dose of the product was voluntarily accepted, was computed for the 5-minute time period (Equation 1)
$$\frac{Number of all successful dosings}{Number of all dosings}X 100$$
Equation 1
The percentage of doses administered to the dogs via ‘assisted administration (pilling) or treat’ past the 5-minute voluntary intake period, was calculated (Equation 2).
$$\frac{Number of dosings administered as assisted administration \left(pilling\right) or treat}{Number of all dosings}X 100$$
Equation 2
The percentage of doses that could not be administered to the dogs even with ‘assisted administration (pilling) or treat’, was calculated (Equation 3).
$$\frac{Number of dosings that could not be administered}{Number of all dosings}X 100$$
Equation 3
The percentage of dogs that voluntarily accepted the dose at all 14 administrations, 13 administrations, 12 administrations etc. was also calculated.
Frequency distributions of breed, sex, and spayed/neutered were calculated. Descriptive statistics for age and initial body weight (mean, standard deviation, minimum and maximum) were calculated.