Abstract Background/Aims While randomised controlled trials (RCTs) in psoriatic arthritis (PsA) show early and durable efficacy of IL-23 inhibitors (i) and IL-17i, real-world data are limited. Previous interim analysis of the PsABIOnd study showed similar 6-month guselkumab (GUS) and IL-17i persistence and effectiveness across PsA domains. This analysis aimed to assess 12-month treatment persistence and effectiveness. Methods PsABIOnd (NCT05049798) is an ongoing global observational study in participants with PsA starting GUS or IL17i as 1st-to-4th line of biologic therapy per standard of care. The primary outcome is treatment persistence at 36 months. In this interim analysis, PsABIOnd participants who had a baseline and ≥1 follow-up assessment up until the 12-month visit (±3 months) were analysed according to their initial treatment, regardless of later switches. Treatment persistence (i.e., no stop/switch) for the overall population and by subgroups of interest (prior biologic experience, biological sex) was assessed over 12 months via Kaplan-Meier estimator function. Propensity score (PS) analysis was used to evaluate hazard ratio (HR) of stopping/switching GUS vs IL-17i prior to the 12-month visit, adjusting for baseline variable imbalances across cohorts. Rates of achievement of clinical Disease Activity Index for PsA (cDAPSA) based minimal clinically important improvement (MCII; improvement by ≥ 5.7), low disease activity (LDA)/remission (REM; ≤13), and REM (≤4), minimal disease activity (MDA), psoriasis body surface area (BSA)<3%, and Dermatology Life Quality Index (DLQI; ≥4) at the 12-month visit were assessed. Results A total of 511 and 504 participants received GUS or IL-17i, respectively, as their initial treatment. Mean age (53.0/53.7 years) and prior targeted therapy use (not GUS/IL-17i; 62.6%/62.9%) were comparable across GUS/IL17i cohorts at baseline. Treatment persistence up to the 12-month visit was high in both cohorts, with 407/511 (79.6%) GUS and 417/504 (82.7%) IL-17i cohort participants remaining on their initial treatment line (PS-adjusted HR GUS vs IL-17i stop/switch [95% confidence interval]: 1.11 [0.85-1.44]). Reasons for initial treatment line discontinuation were generally consistent across groups. Persistence on GUS and IL-17i remained comparable across prior biologic experience and biological sex subgroups. Improvements in joint, skin, and overall disease activity at 12 months were also similar with GUS and IL-17i. Conclusion Participants with PsA had similar 12-month treatment persistence and rates of effectiveness across key PsA domains with GUS or IL-17i, overall and across subgroups of interest. These results add to real-world evidence of the long-term effectiveness of GUS and IL-17i, supporting efficacy data from RTCs. Disclosure S. Siebert: Consultancies; Abbvie, Amgen, Astrazeneca, Johnson & Johnson, Syncona, Teijin Pharma, UCB. Honoraria; AbbVie, Amgen, AstraZeneca, Johnson & Johnson, Syncona, Teijin Pharma, UCB. Member of speakers’ bureau; AbbVie, Amgen, Johnson & Johnson, Novartis, Pfizer, UCB. Grants/research support; Eli Lilly, GSK, Johnson & Johnson, Pfizer, UCB. M. Sharaf: Corporate appointments; Johnson & Johnson. Shareholder/stock ownership; Johnson & Johnson. F. Behrens: Consultancies; Abbvie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Chugai, Eli Lilly, Galapagos, Genzyme, Gilead, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, Sanofi, UCB. Honoraria; Abbvie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Chugai, Eli Lilly, Galapagos, Genzyme, Gilead, Johnson & Johnson, MSD, Novartis, Pfizer, Roche, Sanofi, UCB. Grants/research support; Celgene, Chugai, Johnson & Johnson, Pfizer, Roche. P. Rahman: Consultancies; Abbvie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Johnson & Johnson, Merck, Novartis, Pfizer, UCB. Grants/research support; Johnson & Johnson, Novartis. Other; Meeting attendance/travel support: Johnson & Johnson. M. Kishimoto: Consultancies; AbbVie, Amgen, Asahi-Kasei Pharma, Astellas, Ayumi, Bristol Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Johnson & Johnson, Novartis, Pfizer, Tanabe-Mitsubishi, UCB. Honoraria; AbbVie, Amgen, Asahi-Kasei Pharma, Astellas, Ayumi, Bristol Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Johnson & Johnson, Novartis, Pfizer, Tanabe-Mitsubishi, UCB. E. Soriano: Consultancies; AbbVie, Johnson & Johnson, Novartis, Roche. Member of speakers’ bureau; AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, Roche, UCB. Grants/research support; AbbVie, Johnson & Johnson, Novartis, Pfizer, Roche, UCB. E. Rampakakis: Corporate appointments; JSS Medical Research. Consultancies; Johnson & Johnson. L. Köleséri: Corporate appointments; IQVIA. Consultancies; Johnson & Johnson. K. Lozenski: Corporate appointments; Johnson & Johnson. Shareholder/stock ownership; Johnson & Johnson, Bristol Myers Squibb. M. Koivunen: Corporate appointments; Former employee of Johnson & Johnson. Shareholder/stock ownership; Johnson & Johnson. R. Queiro: Consultancies; AbbVie, Amgen, Celgene, Johnson & Johnson, Eli Lilly, MSD, Novartis, Pfizer. Honoraria; AbbVie, Amgen, Celgene, Johnson & Johnson, Eli Lilly, MSD, Novartis, Pfizer. Grants/research support; AbbVie, Johnson & Johnson, Novartis. E. Lubrano: Honoraria; AbbVie, Amgen, Eli Lilly, GSK, Johnson & Johnson, Novartis, UCB. D. Aletaha: Consultancies; Abbvie, Gilead, Galapagos, Eli Lilly, Johnson & Johnson, Merck, Novartis. Honoraria; Abbvie, Gilead, Galapagos, Eli Lilly, Johnson & Johnson, Merck, Novartis. Grants/research support; Abbvie, Gilead, Galapagos, Eli Lilly, Johnson & Johnson, Merck, Novartis. L. Gossec: Consultancies; AbbVie, AlfaSigma, Amgen, Bristol Myers Squibb, Celltrion, Johnson & Johnson, Eli Lilly, MSD, Novartis, Pfizer, Stada, UCB. Honoraria; AbbVie, AlfaSigma, Amgen, Bristol Myers Squibb, Celltrion, Johnson & Johnson, Eli Lilly, MSD, Novartis, Pfizer, Stada, UCB. Grants/research support; AbbVie, Biogen, Eli Lilly, Novartis, UCB.
更多