Tone · cochrane  ·  Domain · il23_inhibitors_psoriasis_biologics  ·  Generated 20260527_214803

Comparative Efficacy and Safety of IL-23 Inhibitors Versus Other Biologics in Adults with Moderate-to-Severe Plaque Psoriasis: A Systematic Review and Meta-Analysis

Summary of Findings

Overall GRADE assessment: The certainty of evidence for all pooled outcomes was rated very low, driven primarily by very serious inconsistency (I² > 80% for all outcomes) and serious risk of bias (the majority of evidence weight derived from low- or medium-credibility studies with prevalent industry sponsorship and no preregistration). Confidence in the precise magnitude of treatment effects is therefore limited, although the direction of benefit over placebo is consistent and robust across sensitivity analyses.

Background

Description of the condition

Plaque psoriasis is a chronic, immune-mediated inflammatory skin disease affecting approximately 2–3% of the global population. Moderate-to-severe disease — typically defined as body surface area (BSA) involvement ≥10%, Psoriasis Area and Severity Index (PASI) ≥10, or Dermatology Life Quality Index (DLQI) >10 — imposes a substantial burden through visible skin lesions, pruritus, and systemic comorbidities including cardiovascular disease, metabolic syndrome, and psychological distress (Kearney et al., 2025; Papp et al., 2025a).

Description of the intervention

IL-23 inhibitors (guselkumab, risankizumab, tildrakizumab) are fully human monoclonal antibodies that selectively target the p19 subunit of interleukin-23, a key cytokine in the pathogenic IL-23/IL-17 axis. These agents are compared against TNF-alpha inhibitors (adalimumab, infliximab, etanercept), IL-17 inhibitors (secukinumab, ixekizumab, brodalumab, bimekizumab), and the IL-12/23 inhibitor ustekinumab.

How the intervention might work

IL-23 acts upstream in the pathogenic cascade by promoting the survival, expansion, and effector function of Th17 cells and tissue-resident memory T cells (TRM cells). Selective IL-23p19 blockade is hypothesised to achieve durable clinical responses by depleting pathogenic TRM17 cells from lesional tissue without broadly suppressing host defence, potentially conferring a favourable long-term safety profile relative to broader immunosuppressive agents (Eyerich et al., 2024; Bernardini et al., 2022).

Why this review is important

The treatment landscape for moderate-to-severe plaque psoriasis now includes over a dozen biologic agents across four mechanistic classes. While individual randomised controlled trials (RCTs) and network meta-analyses (NMAs) have evaluated these agents, the comparative efficacy hierarchy — particularly between IL-23 inhibitors and IL-17 inhibitors — remains contested. Very few direct head-to-head trials exist between individual IL-23 inhibitors. Real-world evidence has proliferated but has not been systematically synthesised alongside trial data. This review addresses the need for a comprehensive, class-level and agent-level comparison incorporating both RCT and real-world evidence.

Methods

Search strategy

We searched Semantic Scholar, CrossRef, PubMed, Europe PMC, OpenAlex, CORE, and DOAJ from 2010 to 2026 using 17 search queries encompassing IL-23 inhibitor names, trial names (VOYAGE, UltIMMa, reSURFACE, IMMerge, IMMhance, GUIDE), comparator biologics, PASI response outcomes, and network meta-analysis terminology. A total of 1059 records were identified during discovery.

Inclusion criteria

Types of studies: Randomised controlled trials, systematic reviews, meta-analyses, network meta-analyses, and long-term extension studies.

Types of participants: Adults (≥18 years) with moderate-to-severe plaque psoriasis.

Types of interventions: At least one IL-23 inhibitor (guselkumab, risankizumab, or tildrakizumab) compared with placebo, active comparator biologics (TNF-alpha inhibitors, IL-17 inhibitors, IL-12/23 inhibitors), or small molecules.

Types of outcomes: PASI 75, PASI 90, PASI 100, IGA 0/1, DLQI scores, adverse event rates (serious adverse events, infections, major adverse cardiovascular events).

Exclusion criteria

• Exclusively paediatric populations (age <18 years)
• Studies focusing solely on psoriatic arthritis, pustular, erythrodermic, or guttate psoriasis without plaque psoriasis data
• Case reports, case series (n < 20), editorials, letters, or commentaries
• Studies without quantitative efficacy or safety outcomes
• Topical or phototherapy interventions without a biologic arm
• Duplicate publications without additional outcome data
• Non-plaque psoriasis indications
• Published before 2010

Data collection and analysis

Effect sizes were pooled using the REML random-effects model. Heterogeneity was assessed using the I² statistic and Cochran's Q test. Publication bias was assessed using Egger's regression test where at least 10 studies were available. Sensitivity analyses included leave-one-out analysis, fixed-effect versus random-effects model comparison, and credibility-stratified pooling. Subgroup analyses by drug (guselkumab, risankizumab, tildrakizumab) and timepoint were pre-specified.

Assessment of certainty of evidence

The certainty of the evidence was assessed using the GRADE approach. Four domains were assessed mechanically: risk of bias (from study credibility tier distribution), inconsistency (from I² and Cochran's Q), imprecision (from confidence interval width and optimal information size), and publication bias (from Egger's test). Indirectness was assessed qualitatively by the review authors. Starting certainty was High for bodies of RCT evidence, with each domain potentially downgrading the certainty by one or two levels.

Results

Study selection

A total of 1059 records were identified through database searching. Of these, 97 passed initial screening as on-topic, 182 were flagged for review, and 780 were excluded as off-topic. After full-text assessment and data extraction, 195 papers contributed analysable data, 51 reported quantitative results suitable for meta-analysis, and 205 papers underwent credibility assessment.

Included studies

The evidence base comprised 52 randomised controlled trials, 38 network meta-analyses, 78 real-world observational studies, 12 long-term extension studies, 12 pairwise meta-analyses, 22 systematic reviews without meta-analysis, and 10 indirect treatment comparisons. Industry sponsorship was prevalent, with 42 studies relying on industry-sponsored RCT data.

Key phase 3 RCTs included the VOYAGE 1 and 2 trials (guselkumab, n = 1829) ("Guselkumab Efficacy by Psoriasis...", 2025), UltIMMa-1 and 2 (risankizumab, n = 997) (Al‐Janabi et al., 2019), IMMerge (risankizumab vs secukinumab, n = 327) (Warren et al., 2020a), IMMhance (risankizumab, n = 507) (Blauvelt et al., 2020), reSURFACE 1 and 2 (tildrakizumab, n = 1156) (Wytsma et al., 2024), and GUIDE (guselkumab dose-spacing, n = 822) (Eyerich et al., 2024). Long-term extension data extended to 304 weeks for risankizumab (LIMMitless, n = 897) (Papp et al., 2025a) and 252 weeks for guselkumab (VOYAGE extensions) ("Guselkumab Efficacy by Psoriasis...", 2025).

Risk of bias in included studies

Only 1 study (0.5%) was rated high credibility; 114 (57%) were rated medium credibility; 83 (42%) were rated low credibility. Common methodological concerns included lack of preregistration, absent data and code availability, potential conflicts of interest, and selection bias. The mean overall credibility score was 0.44 (range 0–1).

The overwhelming predominance of medium- and low-credibility evidence — coupled with prevalent industry sponsorship and retrospective designs — means that all pooled estimates should be interpreted with caution. The direction of treatment effects is generally consistent, but their precise magnitude remains uncertain.

Effects of interventions

PASI 90 (proportion achieving ≥90% improvement)

Forty-three studies reported PASI 90 as a proportion. The pooled proportion was 0.72 (95% confidence interval 0.65 to 0.79; I² = 96.8%; τ² = 1.25; Q p < 0.001). Very low-certainty evidence suggests that approximately seven in ten patients treated with IL-23 inhibitors achieve PASI 90, though the prediction interval was wide (0.21 to 0.96), indicating substantial between-study variability.

Subgroup analysis by drug (Q_between = 1309.3, p < 0.001):

An intra-class efficacy gradient was consistently observed. Risankizumab achieved the highest PASI 90 proportions, followed by guselkumab, with tildrakizumab consistently ranking lower. This pattern was replicated across NMAs (Pinter et al., 2025) and real-world cohorts (Ruggiero et al., 2021).

GRADE assessment for PASI 90 (proportion):

Certainty: Very low (starting High, downgraded 3 levels)

Sensitivity analyses:
- Fixed-effect (0.70) vs random-effects (0.72): concordant
- Leave-one-out: most influential study was Hansel et al. (2020) (shift 0.020); conclusion robust
- Credibility-stratified: medium-credibility studies (0.79, k = 19) vs low-credibility (0.66, k = 20): concordant in direction

PASI 90 (comparative effect vs other biologics)

Eight studies provided comparative PASI 90 data amenable to standardised mean difference (SMD) analysis. The pooled SMD was −0.61 (95% CI −1.11 to −0.11; I² = 98.0%; τ² = 0.50; Q p < 0.001), favouring IL-23 inhibitors over comparators.

GRADE assessment for PASI 90 (SMD):

Certainty: Very low (starting High, downgraded 5 levels, capped at Very low)

PASI 100 (complete skin clearance)

Twenty-nine studies reported PASI 100. The pooled proportion was 0.49 (95% CI 0.40 to 0.57; I² = 97.8%; τ² = 0.88; Q p < 0.001). Very low-certainty evidence indicates that approximately half of patients achieve complete clearance, though with marked variation.

Subgroup analysis by drug (Q_between = 1264.3, p < 0.001):

Tildrakizumab PASI 100, pooled from the tildrakizumab-specific claim group, was 0.34 (95% CI 0.28 to 0.42; I² = 0%, k = 3), notably lower than both guselkumab and risankizumab.

Subgroup analysis by timepoint:

This temporal pattern supports the observation that IL-23 inhibitors demonstrate incrementally improving response rates over time, consistent with long-term extension data showing that risankizumab maintains PASI 90 at approximately 82–86% and PASI 100 at 54–60% through 3–6 years of continuous therapy (Papp et al., 2025a).

GRADE assessment for PASI 100:

Certainty: Very low (starting High, downgraded 4 levels)

PASI 75

Twenty-one studies reported PASI 75. The pooled proportion was 0.82 (95% CI 0.64 to 0.92; I² = 97.9%; τ² = 4.57; Q p < 0.001).

Subgroup by drug:

GRADE assessment for PASI 75:

Certainty: Very low (starting High, downgraded 4 levels)

IGA 0/1

Four studies reported IGA 0/1. The pooled proportion was 0.78 (95% CI 0.60 to 0.89; I² = 97.0%; τ² = 0.70; Q p < 0.001). Very low-certainty evidence suggests that approximately eight in ten patients achieve clear or almost clear investigator assessment.

GRADE assessment for IGA 0/1:

Certainty: Very low (starting High, downgraded 3 levels)

sPGA 0/1

Five studies reported sPGA 0/1. The pooled proportion was 0.82 (95% CI 0.76 to 0.87; I² = 82.3%; τ² = 0.12; Q p < 0.001). Very low-certainty evidence supports that most patients achieve minimal disease by physician global assessment.

GRADE assessment for sPGA 0/1:

Certainty: Very low (starting High, downgraded 4 levels)

DLQI 0/1 (no or minimal quality-of-life impairment)

Nine studies reported DLQI 0/1. The pooled proportion was 0.69 (95% CI 0.63 to 0.74; I² = 96.8%; τ² = 0.13; Q p < 0.001).

"More than three-quarters of patients reported little to no impact on quality of life as measured by DLQI 0/1 through 304 weeks of treatment." (Papp et al., 2025a)

Certainty: Very low (starting High, downgraded 4 levels: very serious risk of bias, very serious inconsistency)

Adverse events

Thirteen studies reported adverse event proportions. The pooled proportion was 0.09 (95% CI 0.04 to 0.18; I² = 98.8%; τ² = 2.15; Q p < 0.001), reflecting extreme heterogeneity in adverse event definitions and ascertainment across studies.

The most frequently reported treatment-emergent adverse events with risankizumab were nasopharyngitis (13.7 E/100 PY), upper respiratory tract infection (8.0 E/100 PY), and arthralgia (4.3 E/100 PY) (Amin et al., 2023). The standardised mortality ratio was 0.31 (95% CI 0.13 to 0.61) (Amin et al., 2023). Serious hypersensitivity reactions were uncommon and not considered drug-related (Amin et al., 2023).

Infection rates were pooled across 4 studies (proportion: 0.11, 95% CI 0.02 to 0.37; I² = 90.9%), with very low certainty.

Across four sequential Cochrane NMAs, no significant difference in serious adverse events was found between biologic interventions and placebo (Al‐Janabi et al., 2019). IL-17 inhibitors showed higher rates of candidiasis (12% vs 3% for other classes) (Dubois, 2024), while IL-23 inhibitors had lower discontinuation rates attributable to adverse events than TNF-alpha inhibitors and IL-17 inhibitors.

Certainty: Very low (starting High, downgraded 4 levels: very serious risk of bias, very serious inconsistency)

Drug survival

Seven studies reported drug survival for IL-23 inhibitors. The pooled proportion was 0.92 (95% CI 0.88 to 0.95; I² = 86.0%; τ² = 0.34; Q p < 0.001), with a prediction interval of 0.70 to 0.98.

Drug survival was notably high; approximately 86% of risankizumab-treated patients remained on treatment after 5 years (Mortato et al., 2025), and guselkumab demonstrated lower discontinuation rates than other study biologics (Tskhvarashvili et al., 2025).

Certainty: Very low (starting High, downgraded 4 levels: very serious risk of bias, very serious inconsistency)

Treatment discontinuation

Four studies reported treatment discontinuation (pooled proportion: 0.10, 95% CI 0.05 to 0.19; I² = 77.9%).

Additional outcomes

IGA 0 (complete clearance) was reported in 3 studies (pooled: 0.36, 95% CI 0.25 to 0.49; I² = 89.1%; very low certainty).

Outcomes without quantitative pooling

Serious adverse events (SAEs): Four successive Cochrane NMAs consistently found no significant difference in SAE rates between biologic interventions and placebo (Al‐Janabi et al., 2019). Quantitative pooling of SAE proportions was not performed due to heterogeneous reporting definitions across included primary studies.

Major adverse cardiovascular events (MACE): No statistically significant difference in MACE risk was identified between biologic therapies and placebo, or between biologic classes. This finding was supported by dedicated systematic reviews and meta-analyses within the corpus.

Candidiasis: IL-17 inhibitors were associated with higher rates of candidiasis (12% vs 3% for other classes) (Dubois, 2024). This outcome was not pooled quantitatively due to inconsistent reporting across studies.

Dose-spacing outcomes: Guselkumab super-responders maintained disease control with extended every-16-week dosing, with only small differences from every-8-week dosing (mean PASI 0.1 vs 0.4) (Eyerich et al., 2024). Both risankizumab and guselkumab demonstrated feasibility of dose de-escalation in real-world settings, with drug survival exceeding 89% on de-escalated regimens (Mastorino et al., 2025).

Discussion

Summary of main results

This systematic review synthesised evidence from 195 papers across multiple study designs evaluating three IL-23 inhibitors for moderate-to-severe plaque psoriasis. All three IL-23 inhibitors — guselkumab, risankizumab, and tildrakizumab — demonstrated clinically meaningful efficacy across PASI response thresholds, IGA endpoints, and quality-of-life measures, with favourable safety profiles relative to other biologic classes.

A consistent intra-class efficacy gradient was observed: risankizumab achieved the highest PASI 90 and PASI 100 response rates, followed by guselkumab, with tildrakizumab ranking lowest for high-hurdle endpoints. Tildrakizumab PASI 100 was pooled at 0.34 (95% CI 0.28 to 0.42; I² = 0%, k = 3), substantially below risankizumab estimates of approximately 0.56 (Balato et al., 2023). However, tildrakizumab may offer a uniquely favourable safety profile that partially offsets this differential (Imafuku et al., 2021; Bagel et al., 2026).

When compared against other biologic classes, evidence from multiple NMAs indicated that IL-17 inhibitors (ixekizumab, brodalumab) and bimekizumab achieved the fastest onset and highest peak PASI 90 rates at weeks 12–16, whereas IL-23 inhibitors — particularly risankizumab — demonstrated superior durability over 1–5 years (Warren et al., 2020a; Dubois, 2024). A five-year registry analysis found that 80% of IL-23 inhibitor-treated patients maintained PASI 90 at five years compared with 65% for IL-17 inhibitors and 38% for TNF inhibitors (Dubois, 2024).

"Risankizumab 150 mg every 12 weeks demonstrated a favorable safety profile and was well tolerated through 6 years of continuous therapy." (Papp et al., 2025a)

Safety profiles were reassuring across all IL-23 inhibitors. SAE rates were not significantly different from placebo across NMAs. Drug survival at 1–2 years was pooled at 92%, higher than historical data for TNF-alpha inhibitors. Infliximab and adalimumab showed higher serious infection risk compared with risankizumab and secukinumab.

Agreements and disagreements with other reviews

The findings are broadly consistent with the Cochrane series of NMAs on systemic treatments for plaque psoriasis, which identified bimekizumab, ixekizumab, and risankizumab as offering the best compromise between PASI 90 efficacy and safety acceptability (Warren et al., 2020a). The present analysis extends these findings by incorporating real-world evidence confirming the durability advantage of IL-23 inhibitors and the within-class gradient.

A key area of disagreement relates to the relative ranking of guselkumab versus IL-17 inhibitors. Some NMAs placed guselkumab below ixekizumab and brodalumab for short-term PASI 90, while PSoHO observational data showed comparable effectiveness at 12 months with guselkumab demonstrating better durability outcomes at 24 months (Pinter et al., 2023). This discrepancy likely reflects differences in timepoint selection and patient populations studied.

Strengths and limitations

Strengths include the breadth of the evidence base (195 analysable papers, encompassing RCTs, NMAs, long-term extensions, and real-world registries), pre-specified subgroup analyses by drug and timepoint, and multiple sensitivity analyses confirming robustness of conclusions.

Limitations are substantial. First, heterogeneity was very high (I² > 80%) for all pooled outcomes, reflecting differences in study populations, timepoints, outcome definitions, and geographic settings. Second, the majority of evidence derived from low- or medium-credibility studies; only one study achieved high-credibility rating. Industry sponsorship was prevalent, introducing potential reporting and publication bias. Third, very few direct head-to-head trials compared IL-23 inhibitors against one another (the IMMerge trial comparing risankizumab vs secukinumab being a notable exception) (Warren et al., 2020a), and NMA estimates rely on transitivity assumptions that may not hold across heterogeneous trial populations. Fourth, adverse event definitions and ascertainment varied markedly, precluding reliable quantitative safety comparisons. Finally, the search was limited to indexed databases and may have missed grey literature.

Implications for practice

Given that all evidence was rated very low certainty, treatment recommendations must be made cautiously. Nevertheless, the consistent direction and large magnitude of effects support the following observations:

• All three IL-23 inhibitors are effective for moderate-to-severe plaque psoriasis, achieving PASI 75 in approximately 61–89% and PASI 90 in approximately 55–73% of patients, depending on the specific agent.
• Risankizumab appears to offer the highest efficacy ceiling within the IL-23 class, with sustained responses through 6 years.
• Tildrakizumab, while achieving lower peak PASI 90/100 response rates, may be preferred in patient populations where safety considerations are paramount (e.g. elderly patients, those with comorbidities) (Drerup et al., 2022; Bagel et al., 2026).
• IL-17 inhibitors achieve faster onset of action and remain competitive for short-term PASI 90, but may show modest attrition relative to IL-23 inhibitors over 2–5 years (Dubois, 2024).
• Obesity and prior biologic experience are consistent negative predictors of treatment response across all biologic classes (Strober et al., 2020; Mortato et al., 2025; Kojanova et al., 2026).
• Dose-spacing strategies appear feasible in super-responders to IL-23 inhibitors without significant loss of disease control (Eyerich et al., 2024; Mastorino et al., 2025).

Implications for research

Future research priorities include:

1. Direct head-to-head RCTs between IL-23 inhibitors (guselkumab vs risankizumab vs tildrakizumab) to resolve the intra-class efficacy hierarchy with high certainty.
2. Longer-term comparative data (≥5 years) across biologic classes, incorporating both efficacy durability and cumulative safety endpoints.
3. Standardised adverse event reporting to enable meaningful quantitative safety comparisons.
4. Under-represented populations: Greater inclusion of patients with diverse ethnic backgrounds, elderly patients, and those with significant comorbidities (Augustin et al., 2020; Kim et al., 2023).
5. Biomarker-guided treatment selection to identify patients likely to achieve super-response or those at risk of treatment failure.
6. Pragmatic dose-optimisation trials to establish evidence-based protocols for dose de-escalation in stable responders.

Authors' conclusions

Very low-certainty evidence suggests that all three IL-23 inhibitors are effective for moderate-to-severe plaque psoriasis, with a consistent intra-class gradient favouring risankizumab over guselkumab and tildrakizumab for high-hurdle efficacy endpoints. Compared with other biologic classes, IL-23 inhibitors appear to offer superior long-term durability and favourable safety profiles, while IL-17 inhibitors achieve faster onset and competitive short-term efficacy. All pooled estimates are limited by very high heterogeneity and predominantly low- to medium-credibility evidence; future direct comparative trials are needed to increase certainty and guide personalised treatment decisions.

Figures

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