Help us learn more about the safety of using SKYRIZI® (risankizumab-rzaa) and other similar medications during pregnancy.
Patients may be eligible if they are:
*Please note: If your patient has used other medications similar to risankizumab, such as TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitors, or other IL-23 inhibitors, your patient may be eligible to participate. These medications include Stelara (ustekinumab), Cosentyx (secukinumab), Siliq (brodalumab), Taltz (ixekizumab), Tremfya (guselkumab), Ilumya (tildrakizumab), Enbrel (etanercept) or biosimilar (Erelzi, Eticovo, etc), Remicade (infliximab) or biosimilar (Avsola, Inflectra, Ixifi, Renflexis, etc), Humira (adalimumab) or biosimilar (Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, etc), Cimzia (certolizumab), Simponi (golimumab), ORENCIA (abatacept), or ENTYVIO (vedolizumab). If your patient has used any of these medications during or just prior to pregnancy, the registry staff can help determine their eligibility.
Third-party trademarks used herein are trademarks of their respective owners.
Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Risankizumab is also indicated for the treatment of adults with active psoriatic arthritis (PsA) and in adults with moderately to severely active Crohn's disease.
Risankizumab is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, may occur. If a serious hypersensitivity reaction occurs, discontinue risankizumab and initiate appropriate therapy immediately.
Risankizumab may increase the risk of infections. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If such an infection develops, discontinue risankizumab until the infection resolves. Evaluate patients for tuberculosis infection prior to initiating treatment with risankizumab.
Drug-induced liver injury/hepatotoxicity during induction treatment of Crohn’s disease has been reported. Monitor liver enzymes and bilirubin at baseline and during induction (12 weeks). Monitor thereafter according to routine patient management. Consider other treatment options in patients with evidence of liver cirrhosis. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded.
Avoid use of live vaccines in patients treated with risankizumab.
The most common adverse reactions (>3%) reported during treatment for Crohn’s disease are upper respiratory infections, headache, and arthralgia during induction dosing and arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection during maintenance dosing.
The most common adverse reactions (≥1%) reported during treatment for plaque psoriasis and psoriatic arthritis are upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
Review the SKYRIZI® (risankizumab-rzaa) Full Prescribing Information for additional information, visit www.rxabbvie.com or contact AbbVie Medical Information at 1-800-633-9110.
If you have patients who you think may be eligible, you can help them enroll by having them:
Complete the Contact Request Form here and a registry staff member will contact them
Email the registry team with their contact information at: glowpregnancyregistry@ppd.com
Call the registry team toll-free at
1-877-302-2161
(hours of operation 8.30am – 5.00 pm EST Monday-Friday)
Psoriasis is often diagnosed before the patient reaches the age of 40 years, therefore women of childbearing potential may receive drug treatment for psoriasis and may get pregnant during treatment.1 The average age of onset for psoriatic arthritis tends to be slightly later and for Crohn’s disease, slightly earlier; however both conditions can affect persons of any age.2,3 Women with active CD also have an increased risk of preterm delivery, low birth weight, and small-for-gestational-age infants.4
Since pregnant women are excluded from clinical trial participation, there are limited data on the potential impact of using plaque psoriasis, psoriatic arthritis, and Crohn's disease medications during pregnancy on pregnancy and infant outcomes.
Eligible patients and their healthcare providers will provide information to the registry about their pregnancies and the health of their infants up to 1 year of age. This information can be provided by completing paper forms or via a short phone interview with one of the registry staff members. Only information normally documented in patients’ medical records will be collected.
There will be:
Eligible patients and their doctors will receive compensation for providing data to the registry.
The pregnant woman’s healthcare provider(s) will be asked to provide data at enrollment, at approximately the end of the second trimester, and related to pregnancy outcome. For live-born infants, healthcare provider(s) will be asked to provide data at approximately 4 and 12 months after delivery.
The following data will be collected:
Healthcare providers will be compensated when they submit data to the registry
At enrollment, eligible patients will be asked to provide the following information to the registry:
References
1. Tauscher AE, Fleischer AB, Phelps KC, Feldman SR. Psoriasis and pregnancy. J Cutan Med Surg. 2002;6(6):561-70.
2. Koolaee RM, Takeshita J, Ogdie A. Epidemiology and Natural History of Psoriatic Arthritis: an Update What Dermatologists Need to Know. Current Dermatology Reports. 2013;2(1):66-76.
3. Ng SC, Shi HY, Hamidi N, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet 2017;390(10114):2769-78. doi: 10.1016/S0140-6736(17)32448-0 [published Online First: 2017/10/21]
4. Laube R, Paramsothy S, Leong RW. Review of pregnancy in Crohn's disease and ulcerative colitis. Therap Adv Gastroenterol. 2021;14:17562848211016242. Published 2021 May 18.