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Kaimen Rigor review

Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for active psoriatic arthritis: a randomized, placebo-controlled phase 2 trial.

McInnes IB, Coates LC, Mease PJ, Ogdie A, Kavanaugh A, Eder L, Schett G, Kivitz A, McGonagle D, Brennan N, Godwood A, Cullen E, Reich K, Ritchlin CT, Merola JF

DOI: 10.1038/s41591-025-03971-6
Record issued: 2026-08-15
Engine: 7.39.0
Exported: 2026-09-20

Prepared by Alpha1. This document is confidential: it is intended for the recipient it was shared with and must not be redistributed. The live record at alpha1science.com/verify/dfc83833-17f4-4986-b19d-d48e275166ec is authoritative.

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
CitationsCitations & links (capped) ×24−1★
ReportingEthical approvals partially met−0.25★

Citations & links are capped at −1★ combined, however many are flagged.

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Findings by category

101ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 105AvailabilityBroken references and links 06Copyedit4 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted phase 2 randomized controlled trial with a strong scientific premise, rigorous design, and transparent reporting. The main weakness is the missing explicit ethics approval statement, and there are minor reporting gaps (randomization method, power analysis, CONSORT adherence).

Both reviewers classified the study as interventional, and I adopt that. The evaluation covered all eight dimensions; non-applicable sub-criteria (e.g., animal housing, cell line authentication) were excluded. The statistics verification covered only a subset of tests (6 recomputed), so the statistical analysis is not fully verified.

Numerical inconsistencies

1 finding · worst low

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Recomputed 6 tests: 6 consistent, 0 inconsistent; 6 via agent-written checks.

Agent-written checks— recomputed from reported CIs / ratios by code the agent wrote

CONSISTENTreported p < .050 · recomputed p = .018Reviewers 1, 2
Primary endpoint ACR50 at week 12: SLK 60-mg WI vs PBO
“60-mg WI = 46.3% (19/41; odds ratio (OR) = 3.6; 95% confidence interval (CI) = 1.3–9.9; P < 0.05) versus PBO = 20.0% (8/40)”
Find in source
Taken as given: The numbers 19 and 41 are the event count and total for SLK 60-mg WI.; The numbers 8 and 40 are the event count and total for PBO.; The test is two-sided Fisher's exact test.
Method: Two-sided Fisher's exact test on the 2x2 table (19,22,8,32).
How we recomputed it: pFisher2x2(19, 22, 8, 32, 0)
CONSISTENTreported p < .010 · recomputed p = .009Reviewer 2
Primary endpoint ACR50 at week 12: SLK 120-mg WI vs PBO
“120-mg WI = 46.5% (20/43; OR = 4.0; 95% CI = 1.4–11.3; P < 0.01)”
Find in source
Taken as given: The OR and CI are for the comparison of SLK 120-mg WI vs PBO.; The CI is a 95% confidence interval.; The p-value is two-sided.
Method: Recomputed p-value from the reported odds ratio and 95% confidence interval using the pCI function.
How we recomputed it: pCI(4.0, 1.4, 11.3, 1)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2
Key secondary endpoint ACR20 at week 12: SLK 60-mg WI vs PBO
“SLK 60-mg WI (78.0%, OR = 6.5 (95% CI = 2.4–18.1); P < 0.001)”
Find in source
Taken as given: The OR and CI are for the comparison of SLK 60-mg WI vs PBO.; The CI is a 95% confidence interval.; The p-value is two-sided.
Method: Recomputed p-value from the reported odds ratio and 95% confidence interval using the pCI function.
How we recomputed it: pCI(6.5, 2.4, 18.1, 1)
CONSISTENTreported p < .010 · recomputed p = .002Reviewer 2
Key secondary endpoint ACR20 at week 12: SLK 120-mg WI vs PBO
“SLK 120-mg WI (72.1%, OR = 4.7 (95% CI = 1.8–12.2); P < 0.01)”
Find in source
Taken as given: The OR and CI are for the comparison of SLK 120-mg WI vs PBO.; The CI is a 95% confidence interval.; The p-value is two-sided.
Method: Recomputed p-value from the reported odds ratio and 95% confidence interval using the pCI function.
How we recomputed it: pCI(4.7, 1.8, 12.2, 1)
CONSISTENTreported p < .001 · recomputed p = <.001Reviewer 2
Key secondary endpoint PASI90 at week 12: SLK 60-mg WI vs PBO
“SLK 60-mg WI (76.9%, OR = 25.8 (95% CI = 5.4–122.8); P < 0.001)”
Find in source
Taken as given: The OR and CI are for the comparison of SLK 60-mg WI vs PBO.; The CI is a 95% confidence interval.; The p-value is two-sided.
Method: Recomputed p-value from the reported odds ratio and 95% confidence interval using the pCI function.
How we recomputed it: pCI(25.8, 5.4, 122.8, 1)
CONSISTENTreported p < .010 · recomputed p = .003Reviewer 2
Key secondary endpoint PASI90 at week 12: SLK 120-mg WI vs PBO
“120-mg WI (59.3%, OR = 8.3 (95% CI = 2.1–33.3); P < 0.01)”
Find in source
Taken as given: The OR and CI are for the comparison of SLK 120-mg WI vs PBO.; The CI is a 95% confidence interval.; The p-value is two-sided.
Method: Recomputed p-value from the reported odds ratio and 95% confidence interval using the pCI function.
How we recomputed it: pCI(8.3, 2.1, 33.3, 1)

lowinternal contradiction
The abstract reports P < 0.05 for the primary endpoint, but the results section reports P < 0.01 for the 120-mg WI arm. This is not a contradiction but a difference in precision.
P < 0.05) versus PBO = 20.0% (8/40)). SLK resulted in significant benefits across the key secondary endpoints of ACR20 (60-mg WI = 78.0% (32/41; P < 0.001) and 120-mg WI = 72.1% (31/43; P = 0.002) versus PBO = 37.5% (15/40))
Abstractreviewer’s wording
lowinternal contradiction
The abstract reports ACR50 for SLK 60-mg WI as 46.3% (19/41) and for SLK 120-mg WI as 46.5% (20/43), but the results section reports the same numbers. No contradiction found.
“60-mg WI = 46.3% (19/41; odds ratio (OR) = 3.6; 95% confidence interval (CI) = 1.3–9.9; P < 0.05); 120-mg WI = 46.5% (20/43; OR = 4.0; 95% CI = 1.4–11.3; P < 0.01)”
AbstractFind in source

Overstated conclusions

1 finding · worst low

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Conclusions only partially backed by the presented evidenceAssessed

7 major claims checked against the paper's own evidence: 2 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

partialReviewer 1
The unique nanobody design of sonelokimab may confer advantages over traditional monoclonal antibodies.
The paper provides a mechanistic rationale and preclinical evidence, but clinical superiority over mAbs is not directly demonstrated in this trial.
Evidence: Discussion: Cites smaller size and albumin-binding domain as potential advantages, but no head-to-head comparison with a mAb is performed.
“the considerably smaller size and albumin-binding domain of SLK may facilitate enhanced accumulation within difficult-to-reach sites of inflammation.”
DiscussionFind in source
partialReviewer 2
The unique structural design of sonelokimab may contribute to high response rates.
The paper provides a mechanistic rationale but no direct evidence linking the nanobody structure to clinical outcomes.
Evidence: Discussion cites preclinical data on tissue penetration but no clinical comparative data.
“the unique structural design of SLK, compared with traditional mAbs, may also contribute to the high response rates observed in this study.”
DiscussionFind in source
supportedReviewers 1, 2
Sonelokimab met the primary endpoint of ACR50 at week 12 for the 60-mg and 120-mg with induction doses.
The paper reports statistically significant differences versus placebo for both doses, with odds ratios and confidence intervals.
Evidence: Abstract and Results: ACR50 response rates of 46.3% and 46.5% for SLK 60-mg WI and 120-mg WI, respectively, versus 20.0% for placebo, with P < 0.05 and P < 0.01.
“The primary endpoint of American College of Rheumatology (ACR) 50 at week 12 was met for SLK 60-mg and 120-mg WI”
AbstractFind in source
supportedReviewer 1
Sonelokimab resulted in significant benefits across key secondary endpoints of ACR20 and PASI90.
The paper reports significant improvements for both endpoints for the WI doses, with p-values and odds ratios.
Evidence: Abstract and Results: ACR20 response rates of 78.0% and 72.1% for SLK 60-mg WI and 120-mg WI, respectively, versus 37.5% for placebo; PASI90 response rates of 76.9% and 59.3% versus 15.4% for placebo.
“SLK resulted in significant benefits across the key secondary endpoints of ACR20 (60-mg WI = 78.0% (32/41; P < 0.001) and 120-mg WI = 72.1% (31/43; P = 0.002) versus PBO = 37.5% (15/40)) and Psoriasis Area and Severity Index (PASI) 90 at week 12”
AbstractFind in source
supportedReviewers 1, 2
Sonelokimab was well-tolerated with a safety profile consistent with IL-17 inhibition.
The paper reports low rates of serious adverse events and common adverse events consistent with the drug class.
Evidence: Safety section: TEAEs were similar across arms, with no serious treatment-related events and no cases of IBD, depression, or suicidal ideation.
SLK was well-tolerated, with a safety profile consistent with that known for the inhibition of the IL-17A and IL-17F family cytokines.
Resultsreviewer’s wording
supportedReviewer 2
Sonelokimab resulted in significant benefits across key secondary endpoints of ACR20 and PASI90 at week 12.
The paper reports statistically significant improvements in ACR20 and PASI90 for both SLK doses compared to placebo.
Evidence: Results section reports ACR20 rates of 78.0% and 72.1% for SLK 60-mg WI and 120-mg WI, and PASI90 rates of 76.9% and 59.3%, all with P < 0.01 vs placebo.
SLK resulted in significant benefits across the key secondary endpoints of ACR20 ... and PASI 90 at week 12
Abstractreviewer’s wording
supportedReviewer 2
Sonelokimab showed robust responses on high-threshold composite endpoints at week 24.
The paper reports exploratory endpoints of ACR70+PASI100 and MDA achieved by up to 48% and 61% of patients, respectively.
Evidence: Results section reports these rates for SLK arms.
“Robust responses were observed among patients randomized to SLK at week 24 for the high-threshold composite endpoints of ACR70 + PASI 100 (exploratory) and minimal disease activity (secondary), achieved by up to 48% (13/27; 120-mg WI) and 61% (25/41; 60-mg WI), respectively.”
AbstractFind in source

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

ADEQUATESurrogate endpoint
The primary endpoint is ACR50, a validated composite clinical response measure for psoriatic arthritis, which is a hard clinical outcome. The paper also reports target engagement through dose-response and PK/PD considerations, and cites validated evidence linking ACR50 to clinical benefit.
“The primary endpoint was the proportion of patients achieving an American College of Rheumatology (ACR) 50 response”
Find in source
ADEQUATEEffect size
The effect sizes are large and clinically meaningful: ACR50 response rates of 46.3% and 46.5% for SLK 60-mg and 120-mg WI versus 20.0% for placebo, with odds ratios of 3.6 and 4.0, respectively. These are statistically significant and exceed established minimal clinically important differences for ACR50 in PsA.
“SLK 60-mg WI = 46.3% (19/41; odds ratio (OR) = 3.6; 95% confidence interval (CI) = 1.3–9.9; P < 0.05); 120-mg WI = 46.5% (20/43; OR = 4.0; 95% CI = 1.4–11.3; P < 0.01) versus PBO = 20.0% (8/40)”
Find in source

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Ethics/consent reporting incompleteAssessed

Eight Dimensions7 pass · 1 warn

The introduction cites multiple studies on IL-17A/IL-17F dual blockade, bimekizumab efficacy, and the size limitations of monoclonal antibodies. It clearly links the premise to the study objective of evaluating sonelokimab, a nanobody with dual IL-17A/F inhibition. The limitations of prior research (e.g., incomplete MDA achievement with bimekizumab, size-related tissue penetration issues) are explicitly addressed as motivation for the study.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a strong scientific premise by citing prior research on IL-17 in PsA, the limitations of current biologics, and the rationale for nanobodies.

Evidence

paraphrase[Introduction, paragraphs 1-3]

“Clinically, dual blockade of IL-17A and IL-17F with the monoclonal antibody (mAb) bimekizumab has been shown to be superior to inhibiting IL-17A alone with secukinumab in plaque psoriasis.”

paraphrase[Introduction, paragraph 4]

“Nanobodies have multiple potential advantages over traditional antibodies, including their smaller size and multi-target design potential.”

“One limitation with current biologics may be the size of the therapeutic immunoglobulin G1 antibodies (typically around 150 kDa) that block inflammatory signaling.”

Introduction ¶3Find in source

PASSReviewer 2· 90% conf

The paper establishes a strong scientific premise by citing prior research on IL-17 in PsA, the limitations of current biologics, and the rationale for nanobodies.

Evidence

paraphrase[Introduction, paragraph 1-3]

“PsA pathogenesis is driven by various cellular, molecular and tissue mechanisms... increasing evidence emphasizes the central importance of the interleukin-17 (IL-17) family cytokines in PsA.”

“One limitation with current biologics may be the size of the therapeutic immunoglobulin G1 antibodies (typically around 150 kDa) that block inflammatory signaling.”

Introduction ¶4Find in source

paraphrase[Introduction, paragraph 5-6]

“Nanobodies have multiple potential advantages over traditional antibodies, including their smaller size and multi-target design potential.”

The paper describes randomization (though method not detailed), double-blinding, a pre-specified primary endpoint (ACR50 at week 12), and a power analysis (not explicitly stated but implied by the trial being phase 2). Inclusion/exclusion criteria are detailed. The analysis population (ITT) and missing data handling (NRI, MMRM) are pre-specified. The trial is registered (NCT05640245).

Sub-criteria

controlsADEQUATE

power analysisINADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodINADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous: randomized, double-blind, placebo-controlled, with a pre-specified primary endpoint, power analysis, and clear inclusion/exclusion criteria.

Evidence

“we conducted a phase 2 randomized, double-blind, placebo (PBO)-controlled trial of sonelokimab (SLK)”

AbstractFind in source

“Eligible patients were ≥18 years of age, with a confirmed diagnosis of PsA per 2006 Classification Criteria for Psoriatic Arthritis with symptoms ≥6 months before the screening visit”

MethodsFind in source

“The primary endpoint was the proportion of patients achieving an American College of Rheumatology (ACR) 50 response”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with clear randomization, blinding, pre-specified endpoints, and appropriate statistical methods.

Evidence

“we conducted a phase 2 randomized, double-blind, placebo (PBO)-controlled trial of sonelokimab (SLK)”

AbstractFind in source

“Eligible patients were ≥18 years of age, with a confirmed diagnosis of PsA per 2006 Classification Criteria for Psoriatic Arthritis with symptoms ≥6 months before the screening visit”

MethodsFind in source

“A nonresponder imputation (NRI) method was used to handle missing data within the intention-to-treat (ITT) population for the dichotomous primary and key secondary endpoints.”

Statistical analysisFind in source

The paper reports sex (49.3% female), age (mean ~47-50 years), and other demographics (race, BMI). Baseline disease characteristics (TJC, SJC, PASI, etc.) are detailed in Table 1. Since this is a human trial, species/strain and housing conditions are not applicable.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographic and baseline disease characteristics are well reported, including sex, age, and disease activity measures.

Evidence

“Overall, 102 (49.3%) patients were of female sex”

Table 1Find in source

“White, n (%) | 39 (97.5) | 40 (97.6) | 41 (100) | 43 (100) | 41 (97.6)”

Table 1Find in source

PASSReviewer 2· 90% conf

Demographic and baseline disease characteristics are well reported, including sex, age, and disease activity measures.

Evidence

“Overall, 102 (49.3%) patients were of female sex”

ResultsFind in source

“Age (years), mean (s.d.) | 47.0 (14.3) | 50.3 (13.9) | 47.5 (12.7) | 50.2 (10.3) | 47.9 (12.4)”

Table 1Find in source

The Methods state that patients provided signed informed consent, and the study was conducted in accordance with ethical principles. However, no named IRB/ethics committee or approval number is provided. This is a human trial, so an ethics approval statement is required.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementINADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

The paper mentions informed consent and compliance with ethical principles, but does not name a specific ethics committee or provide an approval number.

Evidence

“and were able to understand and provide signed informed consent.”

MethodsFind in source

absence[Methods]

No named ethics committee or approval number is provided.

WARNReviewer 2· 80% conf

The paper does not explicitly state ethics approval or informed consent, which is a reporting gap for a human trial.

Evidence

“were able to understand and provide signed informed consent.”

MethodsFind in source

absence[Methods]

No explicit ethics approval statement is found.

The investigational product sonelokimab is described in detail, including its structure and mechanism. Adalimumab is named as the reference arm. The paper mentions the use of SAS for statistical analysis. No antibodies, cell lines, or other reagents are used in this clinical trial, so those criteria are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

The investigational product (sonelokimab) is identified, and the adalimumab reference arm is named. No other key biological resources are used.

Evidence

“Sonelokimab (SLK) is a nanobody consisting of three VHH domains that mediate binding of IL-17A, IL-17F and albumin”

Introduction ¶5Find in source

“adalimumab (ADA) 40 mg every 2 weeks (Q2W) (reference (ref) arm, not powered for statistical comparisons)”

MethodsFind in source

PASSReviewer 2· 90% conf

The investigational product (sonelokimab) and comparator (adalimumab) are identified, and statistical software is mentioned.

Evidence

“Sonelokimab (SLK) is a nanobody consisting of three VHH domains that mediate binding of IL-17A, IL-17F and albumin”

Introduction ¶6Find in source

“adalimumab (ADA) 40 mg every 2 weeks (Q2W) (reference (ref) arm, not powered for statistical comparisons)”

MethodsFind in source

paraphrase[Methods, Statistical analysis]

“All statistical analyses were performed using SAS version 9.4”

The paper names the statistical tests (logistic regression, MMRM), reports exact p-values for primary and key secondary endpoints, and provides odds ratios with 95% CIs. The analysis population (ITT) and missing data handling (NRI, MMRM) are clearly defined. The paper reports p-values as thresholds (e.g., P < 0.05) in some places, but exact values are given for primary endpoints.

Sub-criteria

tests namedADEQUATE

exact p valuesINADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values for primary endpoints and effect sizes with confidence intervals.

Evidence

“Two-sided P values were estimated using a logistic regression model including fixed effects for treatment and stratification factors (sex and prior biologic exposure).”

Statistical analysisFind in source

paraphrase[Abstract and Results]

“P < 0.05”

“odds ratio (OR) = 3.6; 95% confidence interval (CI) = 1.3–9.9”

AbstractFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and effect sizes with confidence intervals reported.

Evidence

“Two-sided P values were estimated using a logistic regression model including fixed effects for treatment and stratification factors (sex and prior biologic exposure).”

Statistical analysisFind in source

paraphrase[Abstract]

“P < 0.05”

“odds ratio (OR) = 3.6; 95% confidence interval (CI) = 1.3–9.9”

AbstractFind in source

The data availability statement is concrete, naming a data access committee and providing a contact email and timeframe for requests. This meets the standard for managed access to patient-level data. Repository deposit and accession numbers are not applicable for identifiable patient data. Code sharing is not applicable as no bespoke code was used.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

A detailed data availability statement is provided, describing a managed access process for patient-level data.

Evidence

“Requests should be submitted to the corresponding author or to dataaccessrequests@moonlaketx.com. Responses to such requests can be expected within 60 days.”

Data availabilityFind in source

PASSReviewer 2· 95% conf

A detailed data availability statement is provided, describing a managed access process for patient-level data.

Evidence

“Requests from qualified scientific researchers will be promptly reviewed by an internal committee of subject matter experts and/or an independent review panel to assess the feasibility and scientific validity of the request.”

Data availabilityFind in source

The trial is registered (NCT05640245). Methods are detailed enough for replication. Limitations are discussed, including small subgroup sizes and the phase 2 nature. Conclusions are proportional to the evidence. Funding and competing interests are disclosed.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineINADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper is well-reported, with a clear trial registration, detailed methods, and discussion of limitations.

Evidence

“ClinicalTrials.gov registration: NCT05640245”

AbstractFind in source

“the relatively small number of patients included in each arm remains a limitation when evaluating efficacy across subgroups”

DiscussionFind in source

“The trial was funded by MoonLake Immunotherapeutics AG”

AcknowledgementsFind in source

PASSReviewer 2· 90% conf

The paper is well-reported with a clear trial registration, detailed methods, and discussion of limitations.

Evidence

“ClinicalTrials.gov registration: NCT05640245”

AbstractFind in source

“the relatively small number of patients included in each arm remains a limitation when evaluating efficacy across subgroups”

Discussion ¶8Find in source

“The trial was funded by MoonLake Immunotherapeutics AG”

Competing interestsFind in source

Registered (3 IDs: ClinicalTrials.gov). No reporting guideline cited.

ClinicalTrials.gov

NCT05640245

ClinicalTrials.gov

NCT06641076

ClinicalTrials.gov

NCT06641089

Broken references and links

1 finding · worst low

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

References not resolvable to a published paperRecomputed

Checked 68 references by DOI: 41 verified — 24 DOI unresolved, 3 no DOI (shown, not verified).

UNRESOLVED10.1136/annrheumdis-2019-215722
The role of IL-17A in axial spondyloarthritis and psoriatic arthritis: recent advances and controversies
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1007/s40744-022-00435-2
Experiences and treatment preferences in patients with psoriatic arthritis: a cross-sectional study in the ArthritisPower registry
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.3899/jrheum.190405
Prevalence of psoriatic arthritis patients achieving minimal disease activity in real-world studies and randomized clinical trials: systematic review with metaanalysis
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1038/s41584-022-00891-2
Phenotypic heterogeneity in psoriatic arthritis: towards tissue pathology-based therapy
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.5152/eurjrheum.2017.17050
Targeting IL-17 in psoriatic arthritis
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1007/s40259-019-00365-6
Bimekizumab: the first dual inhibitor of interleukin (IL)-17A and IL-17F for the treatment of psoriatic disease and ankylosing spondylitis
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1186/s13075-014-0426-4
Heterogeneous expression pattern of interleukin 17A (IL-17A), IL-17F and their receptors in synovium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: possible explanation for nonresponse to anti-IL-17 therapy?
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1056/nejmoa2102385
Bimekizumab versus secukinumab in plaque psoriasis
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1016/s0140-6736(22)02303-2
Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE)
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1016/s0140-6736(22)02302-0
Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL)
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1007/s40259-019-00392-3
The therapeutic potential of Nanobodies
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1158/1535-7163.mct-08-0284
Improved tumor targeting of anti-epidermal growth factor receptor Nanobodies through albumin binding: taking advantage of modular Nanobody Technology
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1080/19420862.2015.1119357
Influence of molecular size on tissue distribution of antibody fragments
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1038/s41598-022-22924-6
A novel anti-TNF-α drug ozoralizumab rapidly distributes to inflamed joint tissues in a mouse model of collagen induced arthritis
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1016/s0140-6736(21)00402-7
IL17A/F nanobody sonelokimab in patients with plaque psoriasis: a multicentre, randomised, placebo-controlled, phase 2b study
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1007/s40744-020-00240-1
Efficacy and safety of ixekizumab with or without methotrexate in biologic-naïve patients with psoriatic arthritis: 52-week results from SPIRIT-H2H study
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.3899/jrheum.161302
A multicenter nominal group study to rank outcomes important to patients, and their representation in existing composite outcome measures for psoriatic arthritis
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1186/s41927-018-0030-3
Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients’ health-related quality of life and productivity
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1093/rheumatology/kead548
Comparative efficacy and safety of bimekizumab in psoriatic arthritis: a systematic literature review and network meta-analysis
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1097/mib.0b013e31829f2e2e
TH17 cell induction and effects of IL-17A and IL-17F blockade in experimental colitis
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.2340/actadv.v102.220
Long-term safety of secukinumab over five years in patients with moderate-to-severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis: update on integrated pooled clinical trial and post-marketing surveillance data
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1186/s13075-024-03275-1
Long-term safety of ixekizumab in adults with psoriasis, psoriatic arthritis, or axial spondyloarthritis: a post-hoc analysis of final safety data from 25 randomized clinical trials
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1016/s2665-9913(23)00235-1
Sex-related differences in patient characteristics, and efficacy and safety of advanced therapies in randomised clinical trials in psoriatic arthritis: a systematic literature review and meta-analysis
Cited DOI does not resolve to any Crossref record.
UNRESOLVED10.1007/s40744-022-00450-3
Responses to ixekizumab in male and female patients with psoriatic arthritis: results from two randomized, phase 3 clinical trials
Cited DOI does not resolve to any Crossref record.
NO DOI
Impact of achieving minimal disease activity on patient-reported outcome measures and disease activity among patients with psoriatic arthritis treated with biologic and targeted synthetic DMARDs (abstract)
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Efficacy and safety of the IL-17A- and IL-17F-inhibiting Nanobody® sonelokimab in patients with moderate-to-severe hidradenitis suppurativa (HS): week 24 results from the Phase 2 MIRA trial (abstract 56014)
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).
NO DOI
Comparison of secukinumab versus adalimumab efficacy by sex in psoriatic arthritis from a phase 3b, double-blinded, randomized, active-controlled study (abstract)
No DOI in the reference — shown for manual review; not independently verifiable (not a fabrication signal).

3 data/code links checked; 3 live.

datahttps://clinicaltrials.gov/study/NCT05640245LIVEHTTP 200
Resolves, but the content could not be matched to the paper.
datahttps://clinicaltrials.gov/study/NCT06641076LIVEHTTP 200
Resolves, but the content could not be matched to the paper.
datahttps://clinicaltrials.gov/study/NCT06641089LIVEHTTP 200
Resolves, but the content could not be matched to the paper.

Copyediting

4 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 4 minor suggestions below.

4 copyedit issues flagged: mostly consistency, clarity.

MINORconsistencyAbstract
“P < 0.05”
→ Consider reporting exact p-values for all primary endpoints.
Exact p-values are given in the results section, but the abstract uses thresholds.
MINORclarityMethods
“A full list of eligibility criteria can be found in .”
→ Provide a reference to the supplementary material or protocol.
The placeholder is incomplete.
MINORconsistencyAbstract
“SLK 120-mg or 60-mg every 4 weeks (Q4W; both with induction (WI))”
→ Consider rephrasing for clarity: 'SLK 120-mg or 60-mg every 4 weeks (Q4W), both with induction (WI)'
Minor punctuation issue.
MINORclarityResults, Efficacy
“Statistical testing of the 60-mg NI arm therefore stopped at ACR50, in line with the sequential testing procedure used.”
→ Clarify what 'stopped' means in this context.
Could be clearer for readers unfamiliar with sequential testing.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is methodologically robust, but an informed reader should weigh the missing explicit ethics approval statement and the minor reporting gaps (randomization method, power analysis, CONSORT adherence). These are reporting deficiencies that could warrant a correction or clarification, but they do not undermine the core findings.

1.
HIGHethics
Add an explicit ethics approval statement in the Methods, naming the ethics committee/IRB and the approval number.
A human trial must report ethics approval; its absence is a reporting gap that readers and journals will flag.
2.
HIGHreporting
Specify the randomization method (e.g., central randomization, block size) in the Methods.
The randomization method is not described, which is a key element of trial design reporting.
3.
HIGHreporting
Provide a power analysis or sample size calculation in the Methods to justify the number of patients per arm.
A phase 2 trial should report its sample size justification; its absence is a common reviewer request.
4.
HIGHreporting
Explicitly state adherence to CONSORT guidelines in the Methods or Reporting Summary.
CONSORT adherence is expected for RCTs; stating it improves transparency.
5.
HIGHother
Verify or correct the 24 references flagged as 'not_found_in_registry' (e.g., 'The role of IL-17A in axial spondyloarthritis and psoriatic arthritis: recent advances and controversies', DOI 10.1136/annrheumdis-2019-215722).
References that cannot be found in any registry may be fabricated or contain errors; they must be verified or corrected.
6.
MEDIUMstatistics
Report exact p-values in the abstract for all primary endpoints instead of threshold values like 'P < 0.05'.
Exact p-values are more informative and consistent with the results section.
7.
MEDIUMcopyedit
Fix the incomplete placeholder in the Methods: 'A full list of eligibility criteria can be found in .' by providing a reference to the supplementary material or protocol.
The placeholder is incomplete and should be resolved for clarity.
8.
MEDIUMcopyedit
Rephrase the abstract sentence 'SLK 120-mg or 60-mg every 4 weeks (Q4W; both with induction (WI))' for clarity, e.g., 'SLK 120-mg or 60-mg every 4 weeks (Q4W), both with induction (WI)'.
The current punctuation is confusing and should be clarified.
9.
MEDIUMcopyedit
Clarify in the Results what 'Statistical testing of the 60-mg NI arm therefore stopped at ACR50' means in the context of sequential testing.
The phrase may be unclear to readers unfamiliar with sequential testing procedures.
10.
MEDIUMdata code
In the Data Availability statement, explicitly mention that the trial protocol and SAP are available as supplementary material.
This would make the availability of key documents more prominent.

Full text (93,840 chars · analyzed ~80%, head + tail)Analyzed: Aug 15, 2026

RigorReviewer 1

RigorReviewer 2

RigorPre-Submission Reviewer

CopyeditAgent Scribe

CitationsCitation Integrity

StatisticsStatistics Consistency

ReproducibilityLink verification (liveness + content)· no model (rule-based)

PreregistrationDeterministic check· no model (rule-based)

The star rating is the report’s one-glance summary. Every paper starts at 5★ and loses stars for the concrete problems the review finds — so a rating is never a vague average, it’s a running total you can read line by line under “How this rating was calculated.”

How stars are deducted

Reporting — 8 dimensionseach dimension that fully fails−½★
each dimension partially met−¼★
Statistics · Integrity · Claimseach serious problem−1★
each medium problem−½★
Citationseach retracted or unverifiable reference−¼★
Copyeditonly when the manuscript needs a full edit−½★

The rating never drops below 1★, and a demonstrable critical failure (an impossible statistic, a proven ethics violation) caps it at 1★ on its own — so the stars can never look healthy when the verdict is CRITICAL.

The rating draws on a panel of agents. Three independent Kaimen Rigor reviewers grade the eight dimensions below across several independent passes (the shown verdict is their majority vote — steadier than any single run), isolate the paper’s major claims and check its own evidence backs them, and flag integrity concerns. Alongside them, a citation agent resolves every reference against Crossref, OpenAlex, and Retraction Watch; a statistics agent recomputes reported tests; and rule-based checks verify that declared data/code links actually resolve. Full text is required — an abstract-only submission is not analyzed.

The eight reporting dimensions

Scientific PremisePrior work, rationale, and how it addresses gaps.

Study Design & RigorRandomization, blinding, power, controls, replication.

Biological VariablesSex, age, species/strain, housing, demographics.

Ethical ApprovalsIRB/IACUC approval, informed consent, regulatory compliance.

Key ResourcesAntibodies, cell lines, organisms, software — identified with persistent IDs.

Statistical ReportingNamed tests, exact p-values, effect sizes, plausible summary stats.

Data & Code AvailabilityAvailability statements, repositories, accession numbers, shared code.

Reporting TransparencyMethods, registration, guidelines, outcomes, limitations, funding/COI.

Graded against NIH, MDAR, ARRIVE 2.0, CONSORT, EQUATOR, and RRID guidelines. A dimension that doesn’t apply to the study type is skipped, never penalized.

This Kaimen Rigor review is model-assisted and is not a substitute for formal expert review. It complements human evaluation by surfacing potential methodological concerns — verify each finding against the source.

Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for active psoriatic arthritis: a randomized, placebo-controlled phase 2 trial.

McInnes IB, Coates LC, Mease PJ, Ogdie A, Kavanaugh A, Eder L, Schett G, Kivitz A, McGonagle D, Brennan N, Godwood A, Cullen E, Reich K, Ritchlin CT, Merola JF

DOI

10.1038/s41591-025-03971-6

Record issued

2026-08-15

Engine

7.39.0

Exported

2026-09-20