Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

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

Name: Kaimen Rigor review — Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for active psoriatic arthritis: a randomized, placebo-controlled phase 2 trial.
Item: Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for active psoriatic arthritis: a randomized, placebo-controlled phase 2 trial.
Rating: 96
Author: Alpha1

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

Paper source

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Kaimen Rigor review — 2.75★ (Weak), 0 critical, 5 high issues for “Sonelokimab, an IL-17A/IL-17F-inhibiting nanobody for active psoriatic arthritis: a randomized, placebo-controlled phase 2 trial.”

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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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

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DOI

10.1038/s41591-025-03971-6

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

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

Paper source

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

Read full text (PMC)

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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.

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.

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

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.

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).

3 data/code links checked; 3 live.

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.

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.

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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

Read full text (PMC)

DOI

10.1038/s41591-025-03971-6

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Issued Aug 15, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

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

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

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

Overstated conclusions

1 finding · worst low

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.

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

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

1 finding · worst medium

Ethics/consent reporting incompleteAssessed

Eight Dimensions7 pass · 1 warn

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.”

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

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

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.

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”

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

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

Data availabilityFind in source

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.

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).

3 data/code links checked; 3 live.

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.

Kaimen Rigor Action ItemsFinal pass before journal submission

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