P167 Guselkumab and IL-17 inhibitors show comparable treatment persistence and effectiveness in psoriatic arthritis outcomes: 6-month interim results of the PsABIOnd observational cohort study
Bibliographic record
Abstract
Abstract Background/Aims Many drugs have demonstrated efficacy in PsA through randomized controlled trials (RCTs); however, real-world long-term data of drugs are scarce. PsABIOnd is a large, ongoing, global observational study in PsA. The aim of this interim analysis (IA) of the first ≥600 participants (pts) enrolled out of 1300 planned pts in PsABIOnd was to assess treatment persistence and achievement of clinical PsA outcomes at 6 months (M). Methods PsABIOnd (NCT05049798) is an international, prospective, observational study in PsA pts starting guselkumab (GUS) or interleukin-17 inhibitors (IL-17i) as 1st-to-4th line of biologic therapy (monotherapy or in combination with other agents) per standard of care. The primary outcome is treatment persistence at 36M [1]. In this IA, the subset of pts enrolled in the PsABIOnd study who had an assessment at the 6M visit (+/-3M) were analysed according to their initial treatment arm, regardless of later switches. Persistence on treatment was assessed over 6M by treatment line via Kaplan-Meier estimator function. Propensity score (PS) analysis was used to evaluate hazard ratio of stopping or switching GUS vs IL-17i prior to the 6M visit, adjusting for baseline (BL) variables imbalances across cohorts. Effectiveness was assessed at the 6M visit (descriptive unadjusted reports) by treatment line and included rates of achievement of Low Disease Activity (LDA)/remission (REM) by cDAPSA and DAPSA (among pts with polyarticular PsA at BL), MDA (among non-MDA achievers at BL), psoriasis BSA<3% (among pts with BSA≥3% at BL), and resolution of enthesitis by Leeds Enthesitis Index (LEI; among pts with LEI≥1 at BL) and dactylitis (among pts with dactylitis at BL). Results As of 08-Jan-2024, a total of 360 and 326 pts receiving GUS or IL-17i, respectively, as their initial treatment had follow-up data at the 6M visit: mean (GUS/IL-17i) age at BL was 52.0/53.6 years, and 63.1/63.8% pts had previously received at least one targeted drug. The persistence on treatment at the 6M visit was high in both cohorts, with 339/360 (94.2%) pts in the GUS group and 304/326 (93.3%) pts remaining on their initial treatment line at this time point (PS-adjusted hazard ratio of GUS vs IL-17i stop/switch [95% confidence interval]: 0.87 [0.47-1.61]). Reasons for initial treatment line discontinuation were comparable between groups. Treatment effectiveness was similar for GUS vs IL-17i at the 6M visit, with similar rates of achievement cDAPSA LDA/REM (39.7% [95% confidence intervals (CI): [32.3-47.3] vs 34.3% [27.3-41.7]; DAPSA LDA/REM (38.0% [30.0-46.5] vs 38.9% [31.1-47.2]); BSA<3% (34.9% [29.7-40.1] vs 31.5% [26.1-36.9]); MDA (24.0% [19.4-29.0] vs 28.6% [23.4-34.2]); LEI resolution (45.1% [37.6-52.8] vs 48.5% [40.8-56.3]); and dactylitis resolution (60.3% [47.2-72.4] vs 65.6% [52.7-77.1]). Conclusion PsA pts had similar persistence on treatment with GUS or IL17i, and comparable rates of effectiveness across various PsA domains at 6M. Disclosure S. Siebert: Honoraria; AbbVie, Amgen, AstraZeneca, Janssen, Teijin Pharma. Grants/research support; Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, UCB. M. Sharaf: Corporate appointments; Employee of EMEA Medical Affairs, Johnson & Johnson Middle East FZ LLC, Dubai United Arab Emirates. Shareholder/stock ownership; Owns stock in Johnson & Johnson. X. Baraliakos: Consultancies; AbbVie, Chugai, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, UCB. Member of speakers’ bureau; AbbVie, Chugai, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, UCB. Grants/research support; AbbVie, Eli Lilly, Janssen, MSD, Novartis. M. Kishimoto: Consultancies; AbbVie, Amgen, Asahi-Kasei Pharma, Astellas, Ayumi, Bristol Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Tanabe-Mitsubishi, UCB. E. Lubrano: Honoraria; AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, UCB. P. Rahman: Consultancies; AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, UCB. Grants/research support; Janssen, Novartis. Other; Janssen. E. Rampakakis: Corporate appointments; Employee of JSS Medical Research. Consultancies; Janssen. L. Köleséri: Corporate appointments; Employee of IQVIA. Consultancies; Janssen. M. Koivunen: Corporate appointments; Employee of EMEA Medical Affairs, Janssen-Cilag Oy, a Johnson & Johnson company. Shareholder/stock ownership; Owns stock in Johnson & Johnson. F. Lavie: Corporate appointments; Employee of Immunology Global Medical Affairs, Janssen Pharmaceutical Companies. Shareholder/stock ownership; Owns stock in Johnson & Johnson. E. Soriano: Consultancies; AbbVie, Janssen, Novartis, Roche. Member of speakers’ bureau; AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, Roche, UCB. Grants/research support; AbbVie, Janssen, Novartis, Pfizer, Roche, UCB. R. Queiro: Consultancies; AbbVie, Amgen, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer. Grants/research support; AbbVie, Janssen, Novartis. F. Behrens: Consultancies; AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Chugai, Eli Lilly, Galapagos, Genzyme, Gilead, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, UCB. Grants/research support; Celgene, Chugai, Janssen, Pfizer, Roche.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.010 | 0.015 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.004 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".