Risankizumab interacts in the following cases:
In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution.
There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of risankizumab in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of risankizumab during pregnancy.
It is unknown whether risankizumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. A decision should be made whether to discontinue/abstain from risankizumab therapy, taking into account the benefit of breast-feeding to the child and the benefit of risankizumab therapy to the woman.
Women of childbearing potential should use an effective method of contraception during treatment and for at least 21 weeks after treatment.
The effect of risankizumab on human fertility has not been evaluated. Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Risankizumab has no or negligible influence on the ability to drive and use machines.
The most frequently reported adverse reactions were upper respiratory infections (13.0% in psoriasis, 15.6% in Crohn’s disease and 26.2% in ulcerative colitis).
Adverse reactions for risankizumab from clinical studies (Table 1) are listed by MedDRA system organ class and are based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 1. List of adverse reactions:
| System Organ Class | Frequency | Adverse reactions |
|---|---|---|
| Infections and infestations | Very common | Upper respiratory infectionsa |
| Common | Tinea infectionsb | |
| Uncommon | Folliculitis | |
| Nervous system disorders | Common | Headachec |
| Skin and subcutaneous tissue disorders | Common | Pruritus Rash Eczema |
| Uncommon | Urticaria | |
| General disorders and administration site conditions | Common | Fatigued Injection site reactionse |
a Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis, laryngitis, tracheitis
b Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, onychomycosis, tinea infection
c Includes: headache, tension headache, sinus headache
d Includes: fatigue, asthenia, malaise
e Includes: injection site bruising, erythema, haematoma, haemorrhage, irritation, pain, pruritus, reaction, swelling, induration, hypersensitivity, nodule, rash, urticaria, vesicles, warmth; infusion site erythema, extravasation, reaction, swelling
The rate of infections was 75.5 events per 100 subject-years from the psoriasis clinical studies and 43.0 events per 100 subject-years from the psoriatic arthritis clinical studies, including long-term exposure to risankizumab. The majority of cases were non-serious and mild to moderate in severity and did not lead to discontinuation of risankizumab. The rate of serious infections was 1.7 events per 100 subject-years from the psoriasis studies and 2.6 events per 100 subject-years from the psoriatic arthritis studies.
Over the entire psoriasis programme including long-term exposure to risankizumab, the rate of infections was 75.5 events per 100 subject-years. The majority of cases were non-serious and mild to moderate in severity and did not lead to discontinuation of risankizumab. The rate of serious infections was 1.7 events per 100 subject-years.
Overall, the safety profile observed in patients with Crohn’s disease treated with risankizumab was consistent with the safety profile observed in patients across indications.
The rate of infections in the pooled data from the 12-week induction studies was 83.3 events per 100 subject-years in subjects treated with risankizumab 600 mg intravenously compared to 117.7 events per 100 subject-years in placebo. The rate of serious infections was 3.4 events per 100 subject-years in subjects treated with risankizumab 600 mg intravenously compared to 16.7 events per 100 subject-years in placebo.
The rate of infections in the 52-week maintenance study was 57.7 events per 100 subject-years in subjects treated with risankizumab 360 mg subcutaneously after risankizumab induction compared to 76.0 events per 100 subject-years in subjects who received placebo after risankizumab induction. The rate of serious infections was 6.0 events per 100 subject-years in subjects treated with risankizumab 360 mg subcutaneously after risankizumab induction compared to 5.0 events per 100 subject-years in subjects who received placebo after risankizumab induction.
Overall, the safety profile observed in patients with ulcerative colitis treated with risankizumab was consistent with the safety profile observed in patients across indications.
The rate of infections in the pooled data from the 12-week induction study was 78.3 events per 100 subject-years in subjects treated with risankizumab 1 200 mg intravenously compared to 74.2 events per 100 subject-years in placebo. The rate of serious infections was 3.0 events per 100 subject-years in subjects treated with risankizumab 1 200 mg intravenously compared to 5.4 events per 100 subject-years in placebo.
The rate of infections in the 52-week maintenance study was 67.4 events per 100 subject-years in subjects treated with risankizumab 180 mg subcutaneously and 56.5 events per 100 subject-years in subjects treated with risankizumab 360 mg subcutaneously after risankizumab induction compared to 64.6 events per 100 subject-years in subjects who received placebo after risankizumab induction. The rate of serious infections was 1.1 events per 100 subject-years in subjects treated with risankizumab 180 mg subcutaneously and 0.6 events per 100 subject-years in subjects treated with risankizumab 360 mg subcutaneously after risankizumab induction compared to 2.3 events per 100 subject-years in subjects who received placebo after risankizumab induction.
For subjects treated with risankizumab at the recommended clinical dose for up to 52 weeks in psoriasis clinical trials, treatment-emergent anti-drug antibodies and neutralising antibodies were detected in 24% (263/1 079) and 14% (150/1 079) of evaluated subjects, respectively. For subjects exposed to long term treatment of risankizumab (up to 204 weeks in the extension study), the immunogenicity profile observed was consistent compared to the first 52 weeks of treatment.
For most subjects with psoriasis, antibodies to risankizumab including neutralising antibodies were not associated with changes in clinical response or safety. Among the few subjects (approximately 1%; 7/1 000 at week 16 and 6/598 at week 52) with high antibody titres (>128), clinical response appeared to be reduced. The incidence of injection site reactions is numerically higher in the anti-drug antibody-positive groups compared with anti-drug antibody-negative groups over short-term (16 weeks: 2.7% vs 1.3%) and longer-term treatment (>52 weeks: 5.0% vs 3.3%). The injection site reactions were all mild to moderate in severity, none were serious, and none led to discontinuation of risankizumab.
For subjects treated with risankizumab at the recommended clinical dose for up to 28 weeks in psoriatic arthritis clinical trials, treatment-emergent anti-drug antibodies and neutralizing antibodies were detected in 12.1% (79/652) and 0% (0/652) of evaluated subjects, respectively. Antibodies to risankizumab were not associated with changes in clinical response or safety for psoriatic arthritis.
For subjects with Crohn’s disease treated with risankizumab at the recommended intravenous induction and subcutaneous maintenance doses for up to 64 weeks in CD clinical trials, treatment-emergent anti-drug antibodies and neutralizing antibodies were detected in 3.4% (2/58) and 0% (0/58) of evaluated subjects, respectively.
For subjects with ulcerative colitis treated with risankizumab at the recommended intravenous induction and subcutaneous maintenance doses (180 mg or 360 mg) for up to 64 weeks in ulcerative colitis clinical trials, treatment-emergent anti-drug antibodies and neutralising antibodies were detected in 8.9% (8/90) and 6.7% (6/90) for the 180 mg subcutaneous dose, or 4.4% (4/91) and 2.2% (2/91) for the 360 mg subcutaneous dose, of evaluated subjects, respectively.
Antibodies to risankizumab including neutralizing antibodies were not associated with changes in clinical response or safety.
There is limited safety information in subjects aged ≥65 years.
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