Risankizumab
Regulatory sources consulted
- openfda-label-388f783d-f41e-4f04-bf64-ec637fe05bdf
- EMA EPAR EMEA/H/C/004759
- PubMed PMID:39018531 ↗
- PubMed PMID:39037800 ↗
- PubMed PMID:39572132 ↗
- PubMed PMID:39425738 ↗
- PubMed PMID:37216077 ↗
- OpenFDA · L04AC18
- AEMPS CIMA · nº registro 1191361003 ↗
- EMA EPAR · EMEA/H/C/004759 ↗
- RxNorm rxcui 2166040 ↗
Approved indications
- Treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy.
- Treatment of active psoriatic arthritis in adults and pediatric patients 6 years of age and older.
- Treatment of moderately to severely active Crohn's disease in adults.
- Treatment of moderately to severely active ulcerative colitis in adults.
Contraindications
Absolute
- History of serious hypersensitivity reaction to risankizumab or any of the excipients.
Clinical warnings
- Major warning · Infections: May increase the risk of infections. Do not initiate in patients with a clinically important active infection until the infection resolves or is adequately treated. Evaluate for tuberculosis (TB) prior to initiation. — FDA
- Major warning · Hepatotoxicity: Drug-induced hepatotoxicity has been reported in patients with Crohn's disease and ulcerative colitis. Obtain liver enzymes and bilirubin prior to initiating treatment. — FDA
- Major warning · Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur. If a serious reaction occurs, discontinue immediately and initiate appropriate therapy. — FDA
Drug interactions
- HighLive vaccinesJ07
Mechanism: Risankizumab is an immunosuppressant and may increase the risk of infection from live vaccines and decrease the response to vaccination.
Recommendation: Concomitant use of live vaccines should be avoided. Complete all age-appropriate immunizations as per current immunization guidelines prior to initiating therapy with risankizumab.
EMA SPC
Adverse events
Common (≥1%)
upper respiratory infections · headache · fatigue · injection site reactions · arthralgia · tinea infections
Rare but serious
serious infections · serious hypersensitivity reactions (including anaphylaxis) · hepatotoxicity · tuberculosis reactivation
Pregnancy and lactation
Available data on risankizumab use in pregnant women are insufficient to establish a drug-associated risk. Monoclonal antibodies are transported across the placenta and may cause immunosuppression in the in utero-exposed infant. A pregnancy exposure registry exists.
Recent literature (PubMed)
En un ensayo clínico aleatorizado de fase 3b, risankizumab fue no inferior a ustekinumab para la remisión clínica en la semana 24 y superior para la remisión endoscópica en la semana 48 en pacientes con enfermedad de Crohn de moderada a grave que habían fallado a la terapia anti-TNF.
Dos ensayos clínicos de fase 3 (inducción y mantenimiento) demostraron que risankizumab fue más eficaz que el placebo para lograr la remisión clínica en pacientes con colitis ulcerosa de moderada a grave.
La guía de práctica clínica de la AGA recomienda el uso de risankizumab, entre otras terapias avanzadas, para el tratamiento de la colitis ulcerosa de moderada a grave, posicionándolo como una opción de alta eficacia.
Este meta-análisis en red, que informa las guías de la AGA 2024, clasifica a risankizumab entre las opciones más eficaces para la inducción de la remisión en pacientes con colitis ulcerosa de moderada a grave sin exposición previa a biológicos.
Una monografía de formulario que revisa la farmacología, farmacocinética, ensayos clínicos, efectos adversos e interacciones de risankizumab, destinada a los comités de farmacia y terapéutica.