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Ixekizumab: Concomitant Medications Used to Treat Injection Site Reactions in Psoriasis Clinical Trials
Eight percent of patients who experienced a treatment-emergent injection site reaction were reported to have received a concomitant medication to treat the injection site reaction.
The information included in this response is specific to medications that were used to treat ISRs that were reported from the overall psoriasis safety database as of April 2015. The information provided is for reference only and does not constitute a treatment recommendation. Health care decisions to use concomitant medications in patients who experience ISRs with the use of ixekizumab should be based on the best clinical judgment of the prescribing health care practitioner.
Treatment-emergent adverse events were evaluated using MedDRA terms. These were defined as events that first occurred or worsened in severity, relative to baseline, at any time during a clinical study. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a TEAE of the type listed. Adverse events reported during the studies were not necessarily caused by the therapy and the frequencies do not reflect investigator assessment of causality.
Treatment-Emergent Adverse Events of Injection Site Reactions in Psoriasis Clinical Trials
One of the most commonly reported AEs with ixekizumab was ISRs. Injection site reactions were predominantly mild-to-moderate in severity and did not lead to discontinuation of ixekizumab.1
Concomitant Medications Allowed for the Treatment of ISRs in the Psoriasis Clinical Trials
In the ixekizumab trials, patients were allowed OTC analgesics, antihistamines, topical antihistamines and topical steroids.2
The use of concomitant medications to treat ISRs was uncommon (1.5% of ixekizumab Q2W treated patients and 1.6% of etanercept-treated patients) during the first 12 weeks of UNCOVER-1, -2, and -3. Among those who received treatment, the majority received antihistamines.3
aAll psoriasis ixekizumab safety population (N=4209 total patients); Data cutoff of April 2015.
bConcomitant medications listed reflect those reported as ISR for indication in at least 5 patients. Values reflect percentages of all patients who reported use of at least one concomitant medication for ISR. Patients may have received greater than one concomitant medication for ISR.
cDesloratidine (n=3), loratidine (n=2), loratidine with pseudoephedrine (n=1).
dTopical corticosteroids across potency classes were allowed during the open-label treatment period in the UNCOVER studies for any indication for use. The topical corticosteroids referenced in this table given for the indication of ISR (n=1 for each medication listed) consist of betamethasone valerate, fluocinonide, methylprednisolone aceponate (Potent); clobetasol propionate (Very Potent); and hydrocortisone (Weak).
Antihistamines or topical corticosteroids may help with itching or swelling caused by the injection.1
These ISR management tips have not been developed or studied specifically for ixekizumab. Physicians should follow local best practice guidelines in the management of ISRs.
The patient should alternate injection sites. The recommended places for injection of ixekizumab are the abdomen, thigh, or back of arm.1
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711