Risankizumab (SKYRIZI®): A Comprehensive Monograph on its Pharmacology, Clinical Efficacy, and Therapeutic Role in Immune-Mediated Inflammatory Diseases

Executive Summary

Risankizumab, marketed as SKYRIZI®, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that represents a significant advancement in the targeted treatment of several immune-mediated inflammatory diseases. By selectively binding to the p19 subunit of interleukin-23 (IL-23), risankizumab inhibits a key cytokine pathway implicated in the pathophysiology of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. This targeted mechanism of action has translated into a robust clinical profile characterized by high levels of efficacy, durable responses, and a generally favorable long-term safety profile.

Clinical development has consistently demonstrated risankizumab's superiority over placebo and key active comparators. In moderate-to-severe plaque psoriasis, pivotal Phase 3 trials showed significantly higher rates of skin clearance compared to both ustekinumab and adalimumab. For psoriatic arthritis, risankizumab has proven effective in patients with an inadequate response to both conventional synthetic and biologic disease-modifying antirheumatic drugs. In gastroenterology, its approval for Crohn's disease was bolstered by the head-to-head SEQUENCE trial, which established its superiority over ustekinumab in achieving endoscopic remission, a critical treatment goal. Most recently, its approval for ulcerative colitis further expands its therapeutic reach within inflammatory bowel disease. Conversely, the drug's development for atopic dermatitis was discontinued after failing to meet its primary endpoint in a Phase 2 study, a result that underscores the distinct immunopathology of that condition and validates the specificity of the IL-23 pathway as risankizumab's target.

With a convenient maintenance dosing schedule, typically every 8 to 12 weeks via subcutaneous administration, and a consistent safety profile across indications, risankizumab has established itself as a cornerstone therapy in dermatology, rheumatology, and gastroenterology.

Introduction to Risankizumab

Risankizumab is a humanized IgG1 monoclonal antibody engineered to selectively inhibit interleukin-23 (IL-23), a central cytokine in the inflammatory cascade of several chronic immune-mediated diseases.[1] It represents a targeted biologic therapy designed to offer high efficacy and a favorable safety profile for patients with conditions such as psoriasis and inflammatory bowel disease.

Development and Approval History

The development of risankizumab was a collaborative effort between Boehringer Ingelheim and AbbVie, with AbbVie ultimately leading the global development and commercialization of the product, which is marketed under the brand name SKYRIZI®.[3]

The drug's regulatory journey began with its first global approval in Japan in March 2019 for the treatment of psoriasis vulgaris, psoriatic arthritis, generalized pustular psoriasis, and erythrodermic psoriasis.[7] This was quickly followed by approvals for moderate-to-severe plaque psoriasis in Canada, the United States, and Europe in April 2019.[8] The therapeutic applications of risankizumab have since expanded significantly. It gained approval for active psoriatic arthritis and was subsequently approved for moderately to severely active Crohn's disease, becoming the first specific IL-23 inhibitor for this indication.[8] Most recently, in June 2024, the U.S. Food and Drug Administration (FDA) approved risankizumab for the treatment of adults with moderately to severely active ulcerative colitis, further solidifying its role in managing inflammatory bowel diseases.[4] An investigational program for atopic dermatitis was also pursued but ultimately discontinued.[9]

Drug Profile

The fundamental properties of risankizumab are summarized in the table below.

Property	Description	Source(s)
International Nonproprietary Name (INN)	Risankizumab	8
Brand Name	SKYRIZI®	8
DrugBank ID	DB14762	8
CAS Number	1612838-76-2	8
Drug Type	Biotech, Humanized IgG1 Monoclonal Antibody	2
Developer(s)	Boehringer Ingelheim and AbbVie	3
Target	Interleukin-23 alpha subunit p19 (IL-23A)	1

Pharmacology and Mechanism of Action

Risankizumab's therapeutic effect is derived from its precise targeting of the interleukin-23 inflammatory pathway, which is central to the pathogenesis of several chronic autoimmune diseases.

The IL-23/Th17 Pathway in Chronic Inflammation

The IL-23/Th17 axis is a critical component of the immune system that, when dysregulated, drives chronic inflammation. IL-23 is a heterodimeric cytokine composed of a unique p19 subunit and a p40 subunit, the latter of which is also shared by IL-12.[9] Produced by antigen-presenting cells like dendritic cells and macrophages, IL-23 binds to its receptor on immune cells, primarily T helper 17 (Th17) cells, promoting their differentiation, survival, and activation.[1] Activated Th17 cells, along with other immune cells like Th22 cells, subsequently release a cascade of pro-inflammatory cytokines, including IL-17A, IL-17F, and IL-22.[9] While this pathway is essential for host defense against certain pathogens, its persistent activation is a hallmark of diseases such as psoriasis, psoriatic arthritis, and inflammatory bowel disease, where elevated levels of IL-23 are found in affected tissues.[1]

Targeted Inhibition of the IL-23 p19 Subunit

Risankizumab is a humanized IgG1 monoclonal antibody specifically engineered to bind with high affinity (dissociation constant, KD​≤29 pM) to the p19 subunit of human IL-23.[2] By targeting the p19 subunit, risankizumab selectively neutralizes IL-23, preventing it from binding to its cell surface receptor and initiating the downstream inflammatory cascade.[1]

This high degree of specificity is a key feature that distinguishes risankizumab and other second-generation biologics in its class from older agents like ustekinumab. Ustekinumab targets the p40 subunit, thereby inhibiting both IL-12 and IL-23.[9] The selective inhibition of only the IL-23 pathway by risankizumab is thought to provide a more targeted therapeutic effect while sparing the IL-12 pathway, which is involved in different aspects of the immune response. This specificity may contribute to a more favorable benefit-risk profile, a hypothesis that has been explored in direct head-to-head clinical trials.

Pharmacodynamics

By blocking the IL-23/receptor interaction, risankizumab effectively suppresses the IL-23/Th17 axis. This leads to a marked reduction in the production and release of downstream pro-inflammatory cytokines such as IL-17A, IL-17F, and IL-22.[9] Clinical studies have confirmed this mechanism, demonstrating that treatment with risankizumab leads to a significant decrease in inflammatory biomarkers, and these molecular changes correlate with clinical improvements in disease activity.[1] For example, in psoriasis, risankizumab treatment has been shown to normalize the transcriptomic profile in lesional skin, reducing the expression of genes associated with the IL-23/Th17 pathway.[20]

Pharmacokinetics

Risankizumab exhibits pharmacokinetic properties typical of an IgG1 monoclonal antibody, characterized by linear kinetics and a long half-life that supports an infrequent maintenance dosing schedule.[1]

• Absorption and Bioavailability: Following subcutaneous (SC) administration, risankizumab is well absorbed, with peak plasma concentrations (Cmax​) reached between 3 and 14 days. The absolute bioavailability is estimated to be high, at approximately 89%.[9]
• Distribution: The drug shows bi-exponential disposition, and for a typical 90 kg patient, the estimated volume of distribution at steady state (Vss​) is approximately 11.2 L, indicating that its distribution is primarily within the vascular and interstitial spaces.[20]
• Metabolism and Elimination: As a large protein, risankizumab is not eliminated via hepatic or renal pathways. Instead, it is presumed to be cleared through general protein catabolism, broken down into small peptides and amino acids by proteolytic enzymes throughout the body, similar to endogenous IgG.[9] Its clearance is approximately 0.31 L/day.[20]
• Half-Life and Dosing: Risankizumab has a long terminal half-life of approximately 21 to 28 days.[1] This pharmacokinetic profile allows for a convenient maintenance dosing schedule of every 8 or 12 weeks, depending on the indication. Steady-state concentrations are typically achieved by week 16 following the induction doses.[20]
• Covariates and Drug Interactions: Population pharmacokinetic analyses have shown that covariates such as body weight and baseline albumin levels have a statistically significant but not clinically meaningful effect on risankizumab clearance, and thus no dose adjustments are recommended based on these factors.[18] The development of high-titer anti-drug antibodies, which occurs in a small subset of patients (<2%), can increase clearance and reduce efficacy.[21] As expected for a monoclonal antibody, risankizumab does not interact with cytochrome P450 enzymes, and a dedicated drug-drug interaction study (NCT02772601) confirmed its lack of effect on various CYP substrates.[21]

Clinical Efficacy in Approved Indications

The clinical development program for risankizumab has robustly established its efficacy across a range of immune-mediated inflammatory diseases, often demonstrating superiority over existing standards of care.

Moderate-to-Severe Plaque Psoriasis

The efficacy of risankizumab in plaque psoriasis was established through a comprehensive Phase 3 program that included four pivotal trials: UltIMMa-1, UltIMMa-2, IMMhance, and IMMvent. These studies evaluated risankizumab against placebo as well as the active comparators ustekinumab (an IL-12/23 inhibitor) and adalimumab (a TNF inhibitor).[8]

Trial Name	NCT ID	Design	Patient Population	Co-Primary Endpoints (Week 16)	Key Results
UltIMMa-1	NCT02684370	vs. Placebo & Ustekinumab	Moderate-to-severe plaque psoriasis	PASI 90 and sPGA 0/1	Superior to both placebo and ustekinumab at Week 16 and Week 52 25
UltIMMa-2	NCT02684357	vs. Placebo & Ustekinumab	Moderate-to-severe plaque psoriasis	PASI 90 and sPGA 0/1	Superior to both placebo and ustekinumab at Week 16 and Week 52 25
IMMvent	NCT02694523	vs. Adalimumab	Moderate-to-severe plaque psoriasis	PASI 90 and sPGA 0/1	Superior to adalimumab at Week 16; effective in adalimumab partial responders 25
IMMhance	NCT02694523	vs. Placebo (Withdrawal/Re-treatment)	Moderate-to-severe plaque psoriasis	PASI 90 and sPGA 0/1	Superior to placebo at Week 16; maintained response with continuous treatment vs. withdrawal 29

Efficacy vs. Placebo and Ustekinumab (UltIMMa-1 & -2)

The replicate UltIMMa-1 and UltIMMa-2 trials randomized patients with moderate-to-severe plaque psoriasis to receive risankizumab 150 mg, ustekinumab (45 mg or 90 mg), or placebo.[27] At the 16-week primary endpoint, risankizumab demonstrated marked superiority. Approximately 75% of patients treated with risankizumab achieved at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90), compared to approximately 42-48% for ustekinumab and less than 5% for placebo (

p<0.0001). Similarly, 84-88% of risankizumab-treated patients achieved a static Physician's Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1), versus 62-63% for ustekinumab and less than 8% for placebo (p<0.0001).[25] This superiority was maintained through one year (Week 52), with significantly more risankizumab patients achieving PASI 90, PASI 100 (complete skin clearance), and sPGA 0/1 compared to those on ustekinumab.[26]

Efficacy vs. Adalimumab (IMMvent)

The IMMvent trial provided a direct comparison against the widely used TNF inhibitor, adalimumab.[28] At Week 16, risankizumab was superior, with 72% of patients achieving PASI 90 versus 47% of patients treated with adalimumab (

p<0.001).[25]

A particularly valuable aspect of the IMMvent study design was its evaluation of patients who had an intermediate response to adalimumab (PASI 50 to <90) at Week 16. These patients were re-randomized to either continue adalimumab or switch to risankizumab. This design closely mimics a common clinical challenge: managing patients with a suboptimal response to first-line biologic therapy. The results were compelling, showing that 66% of patients who switched to risankizumab achieved PASI 90 by Week 44, compared to only 21% of those who continued on adalimumab (p<0.0001).[28] This provides high-level evidence supporting a switch to risankizumab after an inadequate response to a TNF inhibitor, positioning it as an effective second-line biologic agent.

Long-Term Maintenance and Withdrawal (IMMhance)

The IMMhance study assessed the durability of response and the effects of treatment withdrawal.[30] Patients who achieved clear or almost clear skin (sPGA 0/1) at Week 28 were re-randomized to either continue risankizumab or withdraw to placebo. At one year (Week 52), 87% of patients on continuous treatment maintained their sPGA 0/1 response, compared to only 61% in the withdrawal group, underscoring the necessity of ongoing therapy for sustained disease control.[29] For patients who did relapse after withdrawal, re-treatment with risankizumab was highly effective, with 84% regaining an sPGA 0/1 response within 16 weeks.[38] Long-term data from the open-label extension showed that the high rates of skin clearance were maintained, with 72% of patients on continuous treatment achieving PASI 100 at Week 94.[38]

Patient-Reported Outcomes

Across the psoriasis program, risankizumab treatment led to statistically significant and clinically meaningful improvements in patient-reported outcomes. Compared to both placebo and active comparators, a greater proportion of risankizumab-treated patients reported being free of psoriasis symptoms (PSS=0), having no impact on their quality of life (DLQI=0/1), and experiencing reductions in anxiety and depression (HADS).[31]

Active Psoriatic Arthritis (PsA)

The efficacy of risankizumab in active PsA was evaluated in the KEEPsAKE 1 and KEEPsAKE 2 Phase 3 trials. These studies were designed to assess its efficacy in two important and distinct patient populations: those with an inadequate response or intolerance to conventional synthetic DMARDs (csDMARD-IR), and a more difficult-to-treat group with an inadequate response or intolerance to biologic therapies and/or csDMARDs.[41]

Trial Name	NCT ID	Patient Population	Primary Endpoint (Week 24)	Key Results
KEEPsAKE 1	NCT03675308	csDMARD-IR	ACR20 Response	Met primary endpoint; demonstrated durable efficacy through 196 weeks 44
KEEPsAKE 2	NCT03671148	csDMARD-IR and/or bDMARD-IR	ACR20 Response	Met primary endpoint; demonstrated durable efficacy in a biologic-experienced population through 100 weeks 47

Efficacy in csDMARD-Inadequate Responders (KEEPsAKE 1)

In the KEEPsAKE 1 trial, patients with active PsA who had an inadequate response to csDMARDs were randomized to risankizumab or placebo. At Week 24, 57.3% of patients in the risankizumab group achieved at least a 20% improvement in American College of Rheumatology criteria (ACR20), the primary endpoint, compared to 33.5% in the placebo group (p<0.001).[45] The efficacy was durable, with long-term data showing that 64.3% of patients on continuous risankizumab achieved ACR20 at Week 100, and 38.2% achieved the more stringent Minimal Disease Activity (MDA) endpoint.[44]

Efficacy in Biologic-Experienced Patients (KEEPsAKE 2)

The KEEPsAKE 2 trial enrolled a mixed population that included patients who had previously failed biologic therapy, representing a significant unmet need. Risankizumab again demonstrated superiority over placebo at Week 24 for the primary endpoint of ACR20.[41] Long-term data through 100 weeks confirmed durable efficacy, with 52.5% of patients in the continuous risankizumab group achieving ACR20 and 33.3% achieving MDA.[47] The maintenance of response among those who were responders at Week 52 was high, with approximately 79% maintaining ACR20 and 73% maintaining MDA at Week 100.[47]

Efficacy Across PsA Domains

Integrated analyses of both KEEPsAKE trials demonstrated that risankizumab's efficacy was consistent across various patient subgroups, including those defined by age, sex, and BMI. Significant improvements were observed across multiple domains of PsA, including substantial skin clearance (PASI 90), resolution of enthesitis and dactylitis, and improvements in pain and physical function, with benefits maintained for up to four years.[42]

Moderately to Severely Active Crohn's Disease (CD)

The pivotal program for risankizumab in Crohn's disease comprised two parallel induction studies, ADVANCE and MOTIVATE, and a 52-week maintenance study, FORTIFY. This program was followed by the head-to-head SEQUENCE trial against ustekinumab.[51]

Trial Name	NCT ID	Role	Patient Population	Co-Primary Endpoints	Key Results
ADVANCE	NCT03105128	Induction	Mod-to-sev CD (mixed bio-naïve/exp)	Clinical Remission & Endoscopic Response at Wk 12	Met co-primary endpoints vs. placebo 54
MOTIVATE	NCT03104413	Induction	Mod-to-sev CD (bio-experienced)	Clinical Remission & Endoscopic Response at Wk 12	Met co-primary endpoints vs. placebo 54
FORTIFY	NCT03105102	Maintenance	Responders from ADVANCE/MOTIVATE	Clinical Remission & Endoscopic Response at Wk 52	Met co-primary endpoints vs. placebo withdrawal 52
SEQUENCE	NCT04524611	Head-to-Head	Mod-to-sev CD (post-TNF failure)	Non-inferiority in Clinical Remission (Wk 24); Superiority in Endoscopic Remission (Wk 48)	Met both primary endpoints vs. ustekinumab 58

Induction and Maintenance of Remission

In the ADVANCE and MOTIVATE induction trials, intravenous risankizumab (600 mg and 1200 mg) was significantly more effective than placebo at Week 12 in achieving the co-primary endpoints of clinical remission (defined by both CDAI and patient-reported outcomes) and endoscopic response.[54] As the 1200 mg dose offered no additional benefit, the 600 mg IV dose was established as the standard for induction.[60] In the FORTIFY maintenance trial, patients who responded to induction therapy were re-randomized to receive SC risankizumab (180 mg or 360 mg) or placebo. Both doses of risankizumab were superior to placebo (withdrawal) in maintaining clinical and endoscopic remission at Week 52.[51]

Head-to-Head Superiority vs. Ustekinumab (SEQUENCE)

The SEQUENCE trial was a landmark study that directly compared risankizumab to ustekinumab in patients with moderately to severely active Crohn's disease who had previously failed anti-TNF therapy.[58] The trial was designed with two primary endpoints. At Week 24, risankizumab met the endpoint of non-inferiority to ustekinumab for achieving clinical remission (59% vs. 40%). More importantly, at Week 48, risankizumab demonstrated superiority over ustekinumab for the endpoint of endoscopic remission (32% vs. 16%,

p<0.0001).[58]

The demonstration of superiority on an objective and prognostically important endpoint like endoscopic remission is a critical finding. It provides Level 1 evidence that risankizumab is a more effective option than ustekinumab for achieving deep, mucosal healing in this difficult-to-treat patient population. This result has significant implications for clinical practice, positioning risankizumab as the preferred IL-23 pathway inhibitor for patients with Crohn's disease who have failed anti-TNF therapy.

Moderately to Severely Active Ulcerative Colitis (UC)

The most recent indication for risankizumab is for ulcerative colitis, based on the results from the INSPIRE induction and COMMAND maintenance trials.[4]

Trial Name	NCT ID	Role	Patient Population	Primary Endpoint	Key Results
INSPIRE	NCT03398148	Induction	Moderate-to-severe UC	Clinical Remission at Week 12	Met primary endpoint vs. placebo 64
COMMAND	NCT03398135	Maintenance	Responders from INSPIRE	Clinical Remission at Week 52	Met primary endpoint vs. placebo withdrawal 64

Induction and Maintenance of Remission

In the INSPIRE induction study, 1200 mg of IV risankizumab was significantly superior to placebo at Week 12, with 20.3% of risankizumab-treated patients achieving clinical remission compared to 6.2% of placebo-treated patients (p<0.001).[64] Significant improvements were also seen in key secondary endpoints, including endoscopic improvement (36.5% vs. 12.1%) and HEMI.[4]

In the COMMAND maintenance study, patients who responded to induction were re-randomized to receive SC risankizumab (180 mg or 360 mg) or placebo. At Week 52, both risankizumab doses were superior to placebo in maintaining clinical remission (40.2% for 180 mg and 37.6% for 360 mg vs. 25.1% for placebo).[63] Efficacy was demonstrated in both biologic-naïve and biologic-experienced populations, although response rates were numerically higher in the treatment-naïve cohort.[64]

Investigational Use and Discontinued Development

While risankizumab has achieved broad success, its development has also provided important lessons in indications where it was not effective, most notably atopic dermatitis.

Atopic Dermatitis (AD)

A Phase 2, randomized, double-blind, placebo-controlled trial (NCT03706040) was conducted to evaluate the efficacy and safety of risankizumab (150 mg and 300 mg) in patients aged 12 years and older with moderate-to-severe atopic dermatitis.[74]

The trial failed to meet its primary endpoint, which was the proportion of patients achieving at least a 75% reduction from baseline in the Eczema Area and Severity Index (EASI 75) at Week 16. Neither the 150 mg nor the 300 mg dose of risankizumab demonstrated a statistically significant improvement over placebo.[74]

The failure of risankizumab in this trial provides a compelling clinical illustration of the distinct immunopathologies of atopic dermatitis and psoriasis. Psoriasis is a disease primarily driven by the IL-23/Th17 axis, the very pathway that risankizumab potently inhibits. In contrast, atopic dermatitis is understood to be predominantly driven by Th2-mediated inflammation, involving cytokines such as IL-4 and IL-13. The lack of efficacy of a targeted IL-23 inhibitor in AD reinforces this understanding and validates the specificity of both the drug's mechanism and the distinct disease pathways. This outcome serves as a crucial data point in the field of immunology, guiding future drug development away from the IL-23 axis for AD and reinforcing the focus on Th2-targeted therapies for this condition.

Comprehensive Safety and Tolerability Profile

Across its extensive clinical development program, risankizumab has demonstrated a consistent and generally favorable safety profile. Long-term data from psoriasis trials, extending up to 5.9 years, have not identified new safety signals and show that adverse event rates remain stable over time.[79]

Adverse Event Category	Plaque Psoriasis / Psoriatic Arthritis	Crohn's Disease	Ulcerative Colitis
Most Common (≥1% or >3%)	Upper respiratory infections, headache, fatigue, injection site reactions, tinea infections 13	Induction: Upper respiratory infections, headache, arthralgia. Maintenance: Arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, UTI 13	Induction: Arthralgia. Maintenance: Arthralgia, pyrexia, injection site reactions, rash 13
Serious Adverse Events	Rates similar to placebo; serious infections included pneumonia and cellulitis 25	Serious adverse events occurred in 2.3% of patients vs. 10.2% for placebo during induction 67	Similar rates to placebo; one death from COVID-19 pneumonia in the induction trial was deemed unrelated to study drug 67

Warnings and Precautions

The prescribing information for risankizumab includes several warnings and precautions consistent with its class as an immunomodulatory biologic [13]:

• Hypersensitivity Reactions: Risankizumab is contraindicated in patients with a history of serious hypersensitivity reactions to the drug or its excipients. Anaphylaxis has been reported post-marketing.[13]
• Infections: As an immunosuppressant, risankizumab may increase the risk of infections. Treatment should not be initiated in patients with a clinically important active infection and should be discontinued if a serious infection develops.[13]
• Tuberculosis (TB): Patients must be evaluated for latent or active TB prior to starting therapy. Patients with latent TB should be considered for treatment, and risankizumab is contraindicated in patients with active TB.[13]
• Hepatotoxicity (IBD Indications): For the treatment of Crohn's disease and ulcerative colitis, there is a specific warning for drug-induced liver injury. Evaluation of liver enzymes and bilirubin is required at baseline and during the induction phase. This is not a labeled requirement for the psoriasis or psoriatic arthritis indications.[10]
• Immunizations: The use of live vaccines should be avoided in patients treated with risankizumab. All age-appropriate vaccinations should be completed according to current guidelines prior to initiating therapy.[13]

Immunogenicity

The development of anti-drug antibodies (ADAs) has been observed with risankizumab. In psoriasis trials, approximately 24% of patients developed ADAs by Week 52, with about 14% of all treated patients developing neutralizing antibodies (NAbs).[20] While the presence of ADAs can be associated with lower drug concentrations and a reduced clinical response, this was observed in only a small fraction of patients (approximately 1-2%) and has not been deemed a major clinical concern.[20]

Dosage, Administration, and Formulations

The dosing and administration of risankizumab vary by indication, reflecting different treatment strategies for induction and maintenance phases.

Plaque Psoriasis and Psoriatic Arthritis

• Dosage: The recommended dose is 150 mg administered via subcutaneous (SC) injection at Week 0, Week 4, and every 12 weeks thereafter.[84] For psoriatic arthritis, it can be used as monotherapy or in combination with non-biologic DMARDs.[84]
• Formulations: For these indications, risankizumab is available as a 150 mg/mL prefilled syringe and a 150 mg/mL prefilled pen, facilitating self-administration after proper training.[13]

Crohn's Disease

• Induction Dosing: Treatment is initiated with a 600 mg dose administered by intravenous (IV) infusion over at least one hour. This is repeated at Week 4 and Week 8.[84]
• Maintenance Dosing: Starting at Week 12, the recommended maintenance dosage is either 180 mg or 360 mg administered by SC injection every 8 weeks. The lowest effective dose should be used to maintain response.[84]
• Formulations: The induction dose is supplied in a 600 mg/10 mL single-dose vial for IV infusion. The maintenance doses are available as a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge for use with an on-body injector (OBI).[13]

Ulcerative Colitis

• Induction Dosing: The induction regimen consists of a 1200 mg dose administered by IV infusion over at least two hours at Weeks 0, 4, and 8.[4]
• Maintenance Dosing: At Week 12, patients transition to a maintenance dosage of 180 mg or 360 mg SC every 8 weeks, using the lowest effective dose.[4]
• Formulations: Formulations for UC are the same as those for Crohn's disease.[13]

Comparative Analysis and Therapeutic Positioning

Risankizumab has established a strong position in the therapeutic landscape for immune-mediated diseases, largely due to its high efficacy demonstrated in head-to-head trials against other key biologics.

Endpoint (Week 16)	Risankizumab	Ustekinumab	Adalimumab
PASI 90	~75%	~45%	47%
sPGA 0/1	~86%	~62.5%	60%

Data compiled from UltIMMa-1, UltIMMa-2, and IMMvent trials.[25]

Positioning and Comparisons

• Within the IL-23 Inhibitor Class: Risankizumab, guselkumab, and tildrakizumab all selectively target the p19 subunit of IL-23. While direct comparative trials are scarce, real-world evidence and meta-analyses suggest that risankizumab and guselkumab exhibit the highest drug survival rates, a surrogate for long-term effectiveness and tolerability.[90] Risankizumab's every-12-week maintenance dosing for psoriasis is a key convenience factor for patients compared to some other biologics.[92]
• Versus IL-17 and IL-12/23 Inhibitors: Compared to IL-17 inhibitors like secukinumab and ixekizumab, IL-23 inhibitors may have a slightly slower onset of action but are associated with a different safety profile (e.g., no labeled warning for candidiasis or inflammatory bowel disease exacerbation) and offer a less frequent dosing schedule.[93] The direct superiority of risankizumab over the IL-12/23 inhibitor ustekinumab in both psoriasis and Crohn's disease trials firmly positions it as a more effective agent within this broader mechanistic class.[25]

Role in Treatment Algorithms

• Psoriasis: Due to its demonstrated superiority over both adalimumab and ustekinumab, risankizumab is considered a first-line biologic option for patients with moderate-to-severe plaque psoriasis.
• Psoriatic Arthritis: As shown in the KEEPsAKE trials, risankizumab is an effective treatment for patients who have had an inadequate response to either csDMARDs or prior biologic therapies, making it a versatile option in the PsA treatment paradigm.
• Crohn's Disease: The results of the SEQUENCE trial are practice-defining. By showing superiority over ustekinumab in achieving endoscopic remission in a post-TNF failure population, risankizumab is positioned as a preferred second-line biologic agent for this challenging patient group.
• Ulcerative Colitis: As a newly approved agent, risankizumab provides an important new mechanism of action for patients with UC, offering a highly effective option for both biologic-naïve and treatment-experienced individuals.

Conclusion and Future Perspectives

Risankizumab has emerged as a highly effective and generally safe therapeutic agent for a range of chronic inflammatory diseases. Its selective inhibition of the IL-23 p19 subunit provides a targeted approach that has translated into superior clinical outcomes in head-to-head trials against established standards of care. The durable efficacy, convenient maintenance dosing, and consistent long-term safety profile have solidified its role as a leading therapy in psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

The development of risankizumab exemplifies a successful "pipeline-in-a-product" strategy, methodically expanding from dermatology into gastroenterology based on a strong mechanistic rationale and robust clinical evidence. Ongoing long-term extension studies and a pregnancy registry study will continue to refine our understanding of its long-term safety and utility in special populations.[33] The failure of risankizumab in atopic dermatitis serves as a valuable scientific lesson, reinforcing the importance of precise immunologic targeting and highlighting the distinct pathophysiologies of different inflammatory conditions. Overall, risankizumab represents a significant therapeutic advance, offering patients the potential for profound and lasting disease control.

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