Taltz® (Ixekizumab)

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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.

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Detailed Information

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

As of the April 2015 data cutoff used in this analysis, 53 of the 661 patients (8.0%) who experienced a treatment-emergent ISR were reported to have received a concomitant medication, which was used to treat the ISR.1 Concomitant Medications Provided for Treatment-Emergent ISRs Across 7 Psoriasis Clinical Trials summarizes the concomitant medications used to treat ISRs in the all psoriasis ixekizumab safety population (N=4209 total patients) across 7 clinical trials.

Concomitant Medications Provided for Treatment-Emergent ISRs Across 7 Psoriasis Clinical Trialsa1


n (%)

Total patients with treatment-emergent ISR (N=661)

No reported concomitant medication for indication of ISR

608 (92.0)

Patients with at least 1 concomitant medication for indication of ISR

53 (8.0)

Patients Treated with Concomitant Medications for Indication of ISR (N=53)b

Diphenhydramine

14 (26.4)

Cetirizine

13 (24.5)

Loratidine/Desloratidinec

6 (11.3)

Paracetamol

5 (9.4)

Topical corticosteroidd

5 (9.4)

Topical antihistaminee

5 (9.4)

Abbreviation: ISR = injection site reaction.

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).

eDimetindene maleate (n=4), diphenhydramine hydrochloride (n=1).

Additional Information on Treatment of Injection Site Reactions

It has been reported with other biologics that symptomatic eruptions can be treated with cold compresses.4

Acetaminophen may help relieve pain.1

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

References

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

3Shear NH, Paul C, Blauvelt A, et al. Safety and tolerability of ixekizumab: integrated analysis of injection-site reactions from 11 clinical trials. J Drugs Dermatol. 2018;17(2):200-206. http://jddonline.com/articles/dermatology/S1545961618P0200X

4Clelland S, Hunek JR. Etanercept injection site reaction. Dermatol Nurs. 2005:17(5);375. https://www.medscape.com/viewarticle/515442

Glossary

AE = adverse event

ISR = injection site reaction

IXEQ2W = ixekizumab 80 mg every 2 weeks

MedDRA = Medical Dictionary for Regulatory Activities

OTC = over-the-counter

Q2W = every 2 weeks

TEAE = treatment-emergent adverse event

Fecha de la última revisión: 2021 M05 14


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