Taltz ® (ixekizumab) injektion

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Taltz®▼ (ixekizumab): Behandling av reaktioner på injektionsstället vid psoriasis i kliniska prövningar

Det finns inga specifika rekommendationer för behandling av reaktioner på injektionsstället. I de kliniska prövningarna tilläts patienterna använda receptfria smärtstillande medel, antihistaminer, topiska antihistaminer och topiska steroider.

Information from the Label

One of the most frequently reported AEs with ixekizumab were ISRs.1

The most frequent injection site reactions observed were erythema and pain. These reactions were predominantly mild to moderate in severity and did not lead to discontinuation of ixekizumab.1

TEAEs of Injection Site Reactions and Concomitant Medications in Psoriasis Clinical Trials

The information which follows is specific to medications that were used to treat ISRs that were reported from the overall psoriasis safety database. 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 ixekizumab should be based on the best clinical judgment of the prescribing healthcare practitioner.

In the Ixekizumab clinical trials, patients were allowed OTC analgesics, antihistamines, topical antihistamines and topical steroids. 

As of the April 2015 data cut off used in the below analyses, 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. The concomitant medications used to treat ISRs in the all psoriasis ixekizumab safety population (N=4209 total patients) across 7 clinical trials are summarized in Table 1below.

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.2

Table 1. Concomitant Medications Provided for Treatment-Emergent ISRs across 7 Psoriasis Clinical Trialsa3

Total Patients with Treatment-Emergent ISR (N=661)

No Reported Concomitant Medication for Indication of ISR; n(%)

608 (92.0%)

Patients With at Least 1 Concomitant Medication for Indication of ISR; n(%)

53 (8.0%)

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

Diphenhydramine; n(%)

14 (26.4%)

Cetirizine; n(%)

13 (24.5%)

Loratidine/Desloratidine; n(%)c

6 (11.3%)

Paracetamol; n(%)

5 (9.4%)

Topical Corticosteroid; n(%)d

5 (9.4%)

Topical Antihistamine; n(%)e

5 (9.4%)

Abbreviation: ISR = injection site reaction.

a All Psoriasis Ixekizumab Safety Population (N=4209 total patients); Data cut off of April 2015

b Concomitant 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.

c Desloratidine (n=3), loratidine (n=2), loratidine with pseudoephedrine (n=1).

d Topical 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: Potent- betamethasone valerate, fluocinonide, methylprednisolone aceponate; Very Potent- clobetasol propionate; Weak- hydrocortisone.

e Dimetindene maleate (n=4), diphenhydramine hydrochloride (n=1).

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.

Additional Information on Administration

Ixekizumab is for subcutaneous injection. Injection sites may be alternated. If possible, areas of the skin that show psoriasis should be avoided as injection sites. The solution/the syringe must not be shaken.1

The patient should choose a different site for each injection. The recommended places for injection of ixekizumab are the abdomen, thigh, or back of arm.3

After proper training in subcutaneous injection technique, patients may self-inject ixekizumab if a healthcare professional determines that it is appropriate. However, the physician should ensure appropriate follow-up of patients. Comprehensive instructions for administration are given in the package leaflet and the user manual.1

References

1. Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Shear 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

3. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

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

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2018 M09 10


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