SKYRIZI (risankizumab) is an IL-23/p19 inhibitor indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. SKYRIZI, alone or in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more DMARDs.1
SKYRIZI: An IL-23/p19 inhibitor2-7
KEEPsAKE-1: SKYRIZI vs placebo in bio-naïve patients with active PsA
DURABLE CONTROL OF PsA SIGNS AND SYMPTOMS
could mean everything for your patients
~7 OUT OF 10 PATIENTS ACHIEVED ACR20 AT WEEK 52 (NRI)1,8-10*
SKYRIZI doses denoted in blue: Participants received 150 mg SKYRIZI at Week 0, Week 4, and every 12 weeks thereafter. Starting from Week 28, all subjects received SKYRIZI every 12 weeks. | |
* | Summarized from KEEPsAKE-1 (bio-naïve population). |
† | 65.5% of subjects from KEEPsAKE-1 taking placebo and 65% of SKYRIZI patients were receiving concomitant MTX. 10.2% of patients taking placebo and 10.8% of SKYRIZI patients were receiving concomitant nonbiologic DMARDs other than MTX.8 |
‡ | P≤0.001 vs placebo.1 |
§ | Weeks 52–100 were NRI-C and NRI-MI (see additional study details). |
Weeks 0–12 and 28–100 were not multiplicity-controlled. |
OVER 40% OF SKYRIZI PATIENTS ACHIEVED ACR50 AT WEEK 52 WITH CONSISTENT RATES THROUGH WEEK 100 (NRI)1,8-10*
ARC50 was a prespecified, non-ranked secondary endpoint. | |
* | Summarized from KEEPsAKE-1 (bio-naïve population). |
† | 65.5% of subjects from KEEPsAKE-1 taking placebo and 65% of SKYRIZI patients were receiving concomitant MTX. 10.2% of patients taking placebo and 10.8% of SKYRIZI patients were receiving concomitant nonbiologic DMARDs other than MTX.8 |
‖ | Nominal P≤0.001 vs placebo, not multiplicity-controlled.1 |
¶ | Weeks 52–100 were NRI-C and NRI-MI (see additional study details). |
ACR70 RESPONSE RATES WITH SKYRIZI THROUGH WEEK 100 (NRI)1,8-10*
ACR70 was a prespecified, non-ranked secondary endpoint. | |
* | Summarized from KEEPsAKE-1 (bio-naïve population). |
† | 65.5% of subjects from KEEPsAKE-1 taking placebo and 65% of SKYRIZI patients were receiving concomitant MTX. 10.2% of patients taking placebo and 10.8% of SKYRIZI patients were receiving concomitant nonbiologic DMARDs other than MTX.8 |
|| | Nominal P≤0.001 vs placebo, not multiplicity-controlled.1 |
¶ | Weeks 52–100 were NRI-C and NRI-MI (see additional study details). |
FPO link to approved material content related to KEEPsAKE study
SKYRIZI is dosed 150 mg at Week 0, Week 4, and every 12 weeks thereafter.
Bilateral radiographs of hand and feet: KEEPsAKE-1.
Mixed population=50% csDMARD-IR, 50% Bio-IR population.
* | At Week 16, subjects classified as nonresponders (defined as not achieving at least a 20% improvement in either or both tender joint count and swollen joint count at both Week 12 and Week 16 compared to baseline) had the option to add or modify rescue concomitant medications/therapy. |
† | Starting at Week 36, subjects classified as nonresponders were discontinued from study drug.
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KEEPsAKE-1/2: SKYRIZI vs placebo in bio-naive and bio-experienced patients with active PsA
DURABLE, COMPLETE RESOLUTION OF ENTHESITIS AND DACTYLITIS could mean everything for your patients
CONSISTENT RATES OF COMPLETE RESOLUTION OF ENTHESITIS WITH SKYRIZI (NRI)1,8-10*
CONSISTENT RATES OF COMPLETE RESOLUTION OF DACTYLITIS WITH SKYRIZI (NRI)1,8-10||
SKYRIZI was dosed 150 mg (two 75-mg subcutaneous injections) at Week 0, Week 4, and every 12 weeks thereafter. Starting from Week 28, all subjects received SKYRIZI every 12 weeks. | ||
* | Defined as LEI=0 among patients with LEI>0 at baseline. Pooled data from KEEPsAKE-1 and KEEPsAKE-2.1 | |
† | 59.6% of subjects from both KEEPsAKE-1 and KEEPsAKE-2 studies were receiving concomitant MTX, 11.6% were receiving concomitant nonbiologic DMARDs other than MTX, and 28.9% were receiving SKYRIZI monotherapy.1 | |
‡ | P≤0.001.1 | |
§ | Continuous data points (Week 100) are reported by mixed-effect model repeated measurement (MMRM) and categorical endpoints are reported by as observed with missing data imputed as nonresponders except those missing due to COVID-19, which are imputed by multiple imputation (NRI-MI). | |
|| | Defined as LDI=0 among patients with LDI>0 at baseline. Pooled data from KEEPsAKE-1 and KEEPsAKE-2.1 |
NRI=nonresponder imputation; OLE=open-label extension.
Weeks 52 and 100 were not multiplicity-controlled.
FPO link to approved material content related to KEEPsAKE study
KEEPsAKE-1 and KEEPsAKE-2: study design1,8,11
Two randomized, double-blind, placebo-controlled studies assessing the safety and efficacy of 1,407 patients (964 in KEEPsAKE-1 and 443 in KEEPsAKE-2) ≥18 years old with active PsA.
SKYRIZI is dosed 150 mg at Week 0, Week 4, and every 12 weeks thereafter.
Bilateral radiographs of hand and feet: KEEPsAKE-1. KEEPsAKE-2.
* | Mixed population=50% csDMARD-IR, 50% Bio-IR population. |
† | At Week 16, subjects classified as nonresponders (defined as not achieving at least a 20% improvement in either or both tender joint count and swollen joint count at both Week 12 and Week 16 compared to baseline) had the option to add or modify rescue concomitant medications/therapy. |
‡ | Starting at Week 36, subjects classified as nonresponders were discontinued from study drug. |
Nothing more than 4 INJECTIONS PER YEAR after initiation doses for both PsO and PsA patients1*
NO DOSE ADJUSTMENT regardless of baseline characteristics, including BMI and weight1,12,13†
- SKYRIZI is dosed 150 mg (one 150-mg subcutaneous injection) at Week 0, Week 4, and every 12 weeks thereafter.1
- Low rate of injection site reactions at Week 16 (based on an analysis of 5 PsO clinical trials: SKYRIZI 1.5% vs placebo 1.0%)14
— | In a long-term PsO analysis (up to 8.8 years), rates of injection site reactions were low for SKYRIZI patients (2.8 E/100 PY).15‡ |
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment. Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
* | Maintenance dosing (1 injection/dose) every 12 weeks following a starter dose at Week 0 and Week 4. If a dose is missed, the dose should be administered as soon as possible. Thereafter, dosing should be resumed at the regular scheduled time. |
† | Risankizumab clearance and volume of distribution increase as body weight increases, which may result in reduced efficacy in subjects with high body weight (>130 kg). However, this observation is based on a limited number of subjects. |
‡ | Week 16 (5-study pool) and long-term (median duration of treatment 4.1 years [ranging from 81 days to 8.8 years], 20-study pool) represent different pools of patients with varying lengths of treatment exposure included in the long-term data set.15
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SKYRIZI one injection per dose:
SAME EFFICACY AND SAFETY PROFILE
Same active ingredient | Demonstrated bioequivalence1
NOW EVEN SIMPLER WITH
Note to Affiliate: “New” is a regulated term to be used for up to one year per EFPIA code of practice. Please evaluate use of "Now" in relation to 150 mg presentation, given dates of availability in your country and local requirements.
SKYRIZI 150 mg bioequivalence data1
Bioequivalence was demonstrated between a single SKYRIZI 150-mg injection and two SKYRIZI 75-mg injections in a prefilled syringe. Bioeqivalence was also demonstrated between SKYRIZI 150 mg in a prefilled syringe and a prefilled pen.
* | KEEPsAKE-1: Except for pneumonia, which was reported for 2 patients (0.4%) in the placebo group, no serious AE or severe TEAE was reported for >1 patient in either group. |
† | One death (urosepsis) in an 81-year-old male patient. |
‡ | KEEPsAKE-1 SKYRIZI: Urosepsis (1 patient, resulting in death), cellulitis (1 patient), gastroenteritis (1 patient), COVID-19 pneumonia (1 patient), and viral upper respiratory tract infection leading to pneumonia (1 patient); placebo: pneumonia (2 patients), oral bacterial infection (one patient), dysentery (1 patient), appendicitis (1 patient), and cellulitis (1 patient). KEEPsAKE-2 SKYRIZI: abscess and cellulitis (1 patient) and gastroenteritis (1 patient); placebo: erysipelas, gastroenteritis, postoperative abscess, upper respiratory tract infection, and urinary tract infection (each reported for 1 patient). |
§ | KEEPsAKE-1: All nonserious, resolved with oral antiviral agents and did not result in discontinuation of the study drug. |
|| | KEEPsAKE-2: Both were nonmelanoma skin cancer. |
¶ | All nonserious and did not result in discontinuation of the study drug. |
AEs THROUGH WEEK 100 IN PsA DURING ADMINISTRATION OF SKYRIZI
No new safety signals observed10
SKYRIZI dosed 150 mg at Week 0, Week 4, and every 12 weeks thereafter. | |
* | Data includes all patients who received SKYRIZI 150 mg, including those who started on SKYRIZI 150 mg at randomization and who switched from placebo to SKYRIZI 150 mg after Week 24. |
† | 6 subjects with fatal treatment-emergent events. 2 deaths were related to COVID-19. 1 due to complications related to acute leukemia; 1 with anemia from diverticulosis died due multi-organ failure from septicemia as a complication from anastomosis surgery. 1 81-year-old patient with dementia was hospitalized for pneumonia, developed urosepsis, and complications resulted in death. 1 patient hospitalized for anxiety and depression developed septicemia, nausea, vomiting, fever, and loss of appetite 1 week after discharge and then died from from an unknown cause another week later. Additionally, 1 subject died on Day 363 (166 days after last dose) due to cardiorespiratory arrest. |
‡ | 1 death with the event of coronary artery plaque rupture. Subject had multiple risk factors such as obesity, long history of smoking, hypertension, hypercholesterolemia, and a family history of cardiovascular disease. |
A FAVORABLE PsO SAFETY PROFILE1
No cases of active TB reported in controlled periods of PsO and PsA trials, inlcuding 31 IMMhance study patients with latent TB who did not receive prophylaxis1,18,20-22
Prior to and during SKYRIZI
treatment, evaluate and monitor
patients for TB. Consider anti-TB
therapy prior to initiating
SKYRIZI in patients with
history of latent or active TB.1
Safety profile in PsA consistent with safety profile observed in PsO1
* | Integrated all-risankizumab safety data set from 20 completed or ongoing Phase 1-4 risankizumab clinical trials in plaque psoriasis (data cutoff March 25, 2023). Median duration of treatment was 4.1 years (ranging from 81 days to 8.8 years).15 |
Important contextual information1
SKRYIZI is contraindicated in patients with clinically important active infections (e.g., active tuberculosis).
Tuberculosis: Prior to initiating treatment with SKYRIZI, patients should be evaluated for tuberculosis (TB) infection. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Lab monitoring: SKYRIZI may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, SKYRIZI should be used with caution.
Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Patients treated with SKYRIZI should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and SKYRIZI should not be administered until the infection resolves.
* | UltIMMa: One non–treatment-emergent death of unknown cause on study Day 189 that occurred 161 days after the last dose of study drug. |
† | IMMvent: One patient with acute myocardial infarction on study Day 73 (event was not considered to be study drug–related by investigator). |
‡ | IMMhance: One patient with stroke reported as ischemic stroke on study Day 95. |
§ | IMMhance: One patient with esophageal carcinoma reported on study Day 16, with patient experiencing 40 lbs weight loss six months prior to study participation; one patient with malignant melanoma in situ reported on study Day 102, study drug was not interrupted; one patient with a cutaneous squamous cell carcinoma reported on study Day 89, study drug was not interrupted. |
A safety profile similar to ustekinumab in PsO through Week 52 during RCTs:18
- UltIMMa-1—Any AE: SKYRIZI 61.3% (n=182/297) vs ustekinumab 66.7% (n=66/99); Serious AEs: SKYRIZI 5.4% (n=16/297) vs ustekinumab 4.0% (n=4/99); Infections: SKYRIZI 37.7% (n=112/297) vs ustekinumab 41.4% (n=41/99)
- UltIMMa-2—Any AE: SKYRIZI 55.7% (n=162/291) vs ustekinumab 74.5% (n=70/94); Serious AEs: SKYRIZI 4.5% (n=13/291) vs ustekinumab 4.3% (n=4/94); Infections: SKYRIZI 34.7% (n=101/291) vs ustekinumab 48.9% (n=46/94)
Through Week 52, the frequency of the adverse reactions was similar to the safety profile observed during the first 16 weeks of treatment. Through Week 52, the exposure-adjusted rates of serious adverse events per 100 subject-years were 9.4 for subjects treated with SKYRIZI and 10.9 for those treated with ustekinumab. For those subjects exposed to a maximum of 77 weeks of SKYRIZI, no new adverse reactions were identified compared to the first 16 weeks of treatment.1
A FAVORABLE SAFETY PROFILE EVALUATED UP TO 8.8 YEARS IN PsO WITH PsA DATA UP TO 4 YEARS15,17*
Treatment-emergent AEs from an integrated analysis of PsO and PsA clinical trials15
SKYRIZI warnings and precautions include infections, tuberculosis, and immunizations.1
Additional study details15
- Nasopharyngitis and upper respiratory infection were the most common infections in patients with psoriasis and patients with psoriatic arthritis.
- Excluding COVID-related infections, the most common serious infections (sepsis, pneumonia, and cellulitis) were similar in psoriasis and psoriatic arthritis.
- The rates of serious infections excluding COVID-related infections with SKYRIZI were within the reference rates for serious infections reported for psoriasis (PSOLAR: 0.93–2.91 E/100 PY and psoriatic arthritis (PSOLAR: 1.00–3.01 E/100 PY).
- Rates of opportunistic infections excluding tuberculosis and herpes zoster (both <0.1 E/100 PY) and herpes zoster (0.5 and 0.3 E/100 PY) were comparable for psoriasis and psoriatic arthritis, respectively.
* | Long-term safety was evaluated using integrated all-risankizumab safety data sets (data cutoff March 25, 2023) from 20 Phase 1–4 clinical trials in PsO and 4 Phase 2 and 3 trials in PsA. Median (range) of treatment duration for PsO was 4.1 years (81 days to 8.8 years) and for PsA was 2.8 years (84 days to 4.0 years). For all patients who received ≥1 dose of risankizumab (all administered doses, 18 mg to 180 mg), AEs and AEs of special interest were assessed and recorded through the end of exposure (last dose to first dose + 5 geometric-mean half-lives [20 weeks]). |
† | Excluding COVID-related infections. |
‡ | Excluding tuberculosis and herpes zoster. |
§ | One case of active tuberculosis was reported from Taiwan. The patient in a long-term open-label psoriasis study had latent tuberculosis diagnosed at screening of the feeder study and received isoniazid prophylaxis. He presented with a cough for 4 years after study initiation and was diagnosed based on positive sputum and chest X-ray (diagnostic results such as PCR/culture not provided). |
|| | By system organ class. |
¶ | Reported events: eczema (2), Stevens-Johnson syndrome (2), urticaria (2), angioedema (1), drug hypersensitivity (1), erythema multiforme (1), hypersensitivity (1). |
ACR=American College of Rheumatology; ADA=adalimumab; AE=adverse events; bio-IR=inadequate response to a biologic; BMI=body mass index; CI=confidence interval; csDMARD-IR=inadequate response to a conventional synthetic DMARD; DLQI=Dermatology Life Quality Index; DMARD=disease-modifying antirheumatic drug; E=event; IBD=inflammatory bowel disease; IL=interleukin; LDI=Leeds Dactylitis Index; LEI=Leeds Enthesitis Index; MACE=major adverse cardiovascular event; MTX=methotrexate; NMSC=nonmelanoma skin cancer; NRI=nonresponder imputation; OC=observed case; OLE=open-label extension; PASI=Psoriasis Area and Severity Index; PBO=placebo; PsA=psoriatic arthritis; PsO=psoriasis; PSS=psoriasis symptom scale; PY=patient-year; RCT=randomized controlled trial; sPGA=static Physician’s Global Assessment; TB=tuberculosis; TEAE=treatment-emergent adverse event; TNF=tumor necrosis factor; UST=ustekinumab.
EU Indications and Important Safety Information for SKYRIZI
INDICATIONS1
Skyrizi (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Skyrizi, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritisin adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumaticdrugs (DMARDs).
Skyrizi is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.
IMPORTANT SAFETY INFORMATION1
Risankizumab is contraindicated in patients hypersensitive to the active substance or to any of the excipients, and in patients with clinically important active infections (e.g. active tuberculosis). Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Patients treated with risankizumab should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and risankizumab should not be administered until the infection resolves.
Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.
If a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated.
The most frequently reported adverse reactions were upper respiratory infections (from 13% in psoriasis to 15.6% in Crohn’s disease). Commonly (≥ 1/100 to < 1/10) reported adverse reactions included tinea infections, headache, pruritus, rash, fatigue, and injection site reactions.
This is not a complete summary of all safety information. Please see the SmPC for complete prescribing information.
Find out more about SKYRIZI
References
- SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd; March 2024.
- Puig L. PASI90 response: the new standard in therapeutic efficacy for psoriasis. J Eur Acad Dermatol Venereol. 2015;29(4):645-648. doi:10.1111/jdv.12817
- Strober B, Papp KA, Lebwohl M, et al. Clinical meaningfulness of complete skin clearance in psoriasis. J Am Acad Dermatol. 2016;75(1):77-82.e7. doi:10.1016/j.jaad.2016.03.026
- Gooderham MJ, Papp KA, Lynde CW. Shifting the focus – the primary role of IL-23 in psoriasis and other inflammatory disorders. J Eur Acad Dermatol Venereol. 2018;32(7):1111-1119. doi:10.1111/jdv.14868
- Gaffen SL, Jain R, Garg AV, Cua DJ. The IL-23-IL-17 immune axis: from mechanisms to therapeutic testing. Nat Rev Immunol. 2014;14(9):585-600. doi:10.1038/nri3707
- Girolomoni G, Strohal R, Puig L, et al. The role of IL-23 and the IL-23/TH17 immune axis in the pathogenesis and treatment of psoriasis. J Eur Acad Dermatol Venereol. 2017;31(10):1616-1626. doi:10.1111/jdv.14433
- Lynde CW, Poulin Y, Vender R, Bourcier M, Khalil S. Interleukin 17A: toward a new understanding of psoriasis pathogenesis. J Am Acad Dermatol. 2014;71(1):141-150. doi:10.1016/j.jaad.2013.12.036
- Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2022;81(2):225-231. doi:10.1136/annrheumdis-2021-221019
- Kristensen LE, Keiserman M, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from KEEPsAKE 1. Poster presented at: Fall Clinical Dermatology Conference (FC21); October 21–24, 2021; Las Vegas, Nevada.
- Kristensen LE, Papp K, White D, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 100-week results from the KEEPsAKE 1 and KEEPsAKE 2 trials. Poster presented at: 2022 European Academy of Dermatology and Venereology (EADV) Virtual Congress; September 7–10, 2022.
- Östör A, Van den Bosch F, Papp K, et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial. Ann Rheum Dis. 2022;81(3):351-358. doi:10.1136/annrheumdis-2021-221048
- Leonardi C, Gordon K, Longcore M, Gu Y, Puig L. Weight-based analysis of psoriasis area and severity index improvement at 52 weeks of risankizumab or ustekinumab treatment: an integrated analysis of patients with moderate-to-severe plaque psoriasis. Poster presented at: 24th World Congress of Dermatology (WCD); June 10–15, 2019; Milan, Italy. Poster 5248.
- Strober B, Menter A, Leonardi C, et al. Efficacy of risankizumab in patients with moderate-to-severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa-1 and UltIMMa-2 studies. J Eur Acad Dermatol Venereol. 2020;34(12):2830-2838. doi:10.1111/jdv.16521
- Leonardi C, Bachelez H, Wu JJ, et al. Safety of risankizumab in patients with moderate to severe psoriasis: analysis of pooled short-term and long-term clinical trial data. Poster presented at: 24th World Congress of Dermatology (WCD); June 10–15, 2019; Milan, Italy. Poster 3591.
- Gordon KB, Blauvelt A, Bachelez H, et al. Long-term safety of risankizumab in patients with psoriatic disease: integrated analysis of psoriasis and psoriatic arthritis clinical trial data. Poster presented at: 2023 European Academy of Dermatology and Venereology (EADV) Congress; October 11-13, 2023. Berlin, Germany.
- Blauvelt A, Gordon KB, Lee P, et al. Efficacy, safety, usability, and acceptability of risankizumab 150 mg formulation administered by prefilled syringe or by an autoinjector for moderate to severe plaque psoriasis. J Dermatolog Treat. 2021;1-9. doi:10.1080/09546634.2021.1914812
- Gordon KB, Blauvelt A, Coates L, et al. Risankizumab long-term safety in patients with psoriatic disease: integrated analyses of data from psoriasis and psoriatic arthritis clinical trials. Poster presented at: 2022 European Academy of Dermatology and Venereology (EADV) Virtual Congress; September 7-10, 2022. Poster 1607.
- Gordon KB, Strober B, Lebwohl M, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650-661. doi:10.1016/S0140-6736(18)31713-6
- Gordon KB, Strober B, Lebwohl M, et al. Supplement to: Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet. 2018;392(10148):650-661. doi:10.1016/S0140-6736(18)31713-6
- Reich K, Gooderham M, Thaçi D, et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019;394(10198):576-586. doi:10.1016/S0140-6736(19)30952-3
- Blauvelt A, Papp KA, Gooderham M, et al. Efficacy and safety of risankizumab, an IL-23 inhibitor, in patients with moderate-to-severe chronic plaque psoriasis: 16-week results from the phase 3 IMMhance trial. Paper presented at: Psoriasis: From Gene to Clinic Meeting, November 30–December 3, 2017; London, United Kingdom.
- Langley RG, Blauvelt A, Gooderham M, et al. Efficacy and safety of continuous Q12W risankizumab versus treatment withdrawal: results from the phase 3 IMMhance trial. Poster presented at: 2019 American Academy of Dermatology (AAD) Annual Meeting; March 1–5, 2019; Washington, DC. Poster 10093.