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Abstract Number: 1944

Sustained Remission/Low Disease Activity Is Feasible in the Long Term in Patients with Psoriatic Arthritis Treated with IL-23/12 Inhibition with Ustekinumab (STELARA®) and Tumor Necrosis Factor Inhibitors in a Real-World, Multicenter Study

Josef Smolen1, Paul Bergmans2, Kurt de Vlam3, Elisa Gremese4, Beatriz Joven-Ibáñez5, Tatiana Korotaeva6, Wim Noël7, Michael Nurmohamed8, Petros Sfikakis9, Stefan Siebert10, Elke Theander11 and Laure Gossec12, 1Medical University of Vienna, Vienna, Austria, 2Janssen-Cilag BV, Breda, Netherlands, 3University Hospitals Leuven, Leuven, Belgium, 4Fondazione Policlinico A Gemelli-IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy, 5University Hospital 12 de Octubre, Madrid, Spain, 6VA Nasonova Research Institute of Rheumatology, Moscow, Russia, 7Janssen Pharmaceutica, HEMAR Department, Beerse, Belgium, 8Reade and Amsterdam University Medical Center, location VUmc, Amsterdam, Netherlands, 9National Kapodistrian University of Athens Medical School, Athens, Greece, Athens, Greece, 10University of Glasgow, Glasgow, United Kingdom, 11Janssen Cilag, Lund, Sweden, 12Sorbonne Université and Hôpital Pitié-Salpêtrière, Paris, France

Meeting: ACR Convergence 2021

Keywords: Anti-TNF Drugs, Biologicals, Psoriatic arthritis

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Session Information

Date: Tuesday, November 9, 2021

Session Title: Abstracts: Spondyloarthritis Including PsA – Treatment II: Biologic Therapies (1943–1946)

Session Type: Abstract Session

Session Time: 4:15PM-4:30PM

Background/Purpose: Among treatment options for PsA, IL-23/12 inhibition with ustekinumab (UST) was the first new biologic after TNF inhibitors (TNFi). Few data compare long-term effectiveness between UST and TNFi. Here we present the final 3-year analysis from the real-world PsABio study, focusing on the achievement of minimal disease activity (MDA)/very low disease activity (VLDA) and low disease activity (LDA) or remission, as measured by clinical disease activity in psoriatic arthritis (cDAPSA).

Methods: The PsABio study (NCT02627768) evaluated effectiveness, tolerability and persistence of 1st, 2nd, or 3rd-line UST or TNFi in patients (pts) with PsA. Here we present proportion of pts reaching MDA/VLDA and cDAPSA LDA or remission up to 3 years (assessments for pts under the initial treatment at 3 years). Descriptive statistics included the last observation carried forward (LOCF) endpoint created in case of missing 3-year effectiveness data; for example, due to COVID-19. Cohort comparison was done among pts who stayed on their initial UST or TNFi treatment for the full 3 years (remainer analysis), and among those who switched/stopped their original treatment, imputed as non-responders (overall analysis). Logistic regression analysis presenting odds ratios (ORs) and 95% confidence intervals (CIs), including propensity score (PS), stratified on quintiles (inverse probability of treatment weighting as sensitivity analysis) to adjust for imbalanced baseline (BL) covariates.

Results: The overall analysis (n=895) included 439 UST and 456 TNFi-treated pts who had evaluable BL and follow-up data up to 3 years. The remainer analysis included 186 (42.4%) UST and 188 (41.2%) TNFi-treated pts staying on their initial treatment up to 36 ± 3 months. In both the overall and remainer analyses, UST and TNFi groups had significant BL differences in age and psoriasis skin involvement (body surface area >10%); in the overall analysis, significant difference was seen for 1st and 3rd bDMARD line of treatment (Table 1).

In the remainer analysis, both UST and TNFi treatments led to a significant proportion of pts achieving MDA (up to 78%; Figure 1a), VLDA (up to 43%; Figure 1b), cDAPSA LDA (up to 89%; Figure 1c), and cDAPSA remission (up to 64%; Figure 1d). The PS-adjusted ORs (95% CI) indicated a similar response in both cohorts (Figure 1a–d). The overall analysis, which included pts switching/stopping initial treatment during the 3-year period, showed similar results (Figure 2a–d).

Conclusion: In the prospectively followed PsABio study across Europe, slightly more than 40% of pts with PsA stayed on UST or TNFi for 3 years or more. This long-term treatment, when used as 1st-, 2nd-, or 3rd-line bDMARD in a routine care setting, provided sustained improvement of disease signs and symptoms, enabling achievement of MDA, VLDA, cDAPSA LDA, or cDAPSA remission. While numerically more TNFi-treated pts achieved LDA or remission states, UST was used in more treatment-resistant patients and there was no statistical difference between the treatment groups; the improvements were maintained over the 3-year period. The findings demonstrate that remission/LDA are feasible when using targeted drugs in PsA.

Table 1: Observed baseline characteristics of overall patients (n=895) and remainers (n=374)

Figure 1: Observed proportions of patients and PS-adjusted ORs (95% CI) achieving: (a) MDA; (b) VLDA; (c) cDAPSA LDA; and (d) cDAPSA remission with UST or TNFi up to 3 years (remainer analysis). Results reflect 3-year LOCF data from assessments for patients still under initial treatment at 3 years. *Includes remission. BL, baseline; CI, confidence interval; LOCF, last observation carried forward; LDA, low disease activity; MDA; minimal disease activity; OR, odds ratio; PS, propensity score; TNFi, TNF inhibitor; UST, ustekinumab; VLDA, very low disease activity.

Figure 2: Observed proportions of patients and PS-adjusted ORs (95% CI) achieving: (a) MDA; (b) VLDA; (c) cDAPSA LDA; and (d) cDAPSA remission with UST or TNFi up to 3 years (overall analysis). The overall analysis included patients switching/stopping their original treatment during the 3-year observation period. The PS-adjusted ORs resulting from the overall analysis included non-response imputation in case of stop/switch initial treatment. *Includes remission. BL, baseline; CI, confidence interval; LOCF, last observation carried forward; LDA, low disease activity; MDA; minimal disease activity; OR, odds ratio; PS, propensity score; TNFi, TNF inhibitors; UST, ustekinumab; VLDA, very low disease activity.


Disclosures: J. Smolen, AbbVie, 2, 5, BMS, 2, 5, Celegene, 2, 5, Chugai, 2, 5, Gilead, 2, 5, Janssen, 2, 5, Eli Lilly, 2, 5, MSD, 2, 5, Novartis-Sandoz, 2, 5, Pfizer, 2, 5, Roche, 2, 5, Samsung, 2, 5, Sanofi, 2, 5, UCB, 2, 5; P. Bergmans, Janssen, 3, Johnson & Johnson, 11; K. de Vlam, Amgen, 6, 7, AbbVie, 6, Celgene, 2, 5, 6, Eli Lilly, 2, Johnson & Johnson, 2, Novartis, 2, 6, Galapagos, 2, 7, UCB, 2, 6, 7; E. Gremese, AbbVie, 2, 6, UCB, 2, 6, Pfizer, 2, 6, Janssen, 2, 6, Boehringer Ingelheim, 2, 6, Celgene, 2, 6, Novartis, 2, 6; B. Joven-Ibáñez, AbbVie, 6, 12, Participant in clinical trials, Celgene, 2, 6, Janssen, 2, 6, 12, Participant in clinical trials, Novartis, 2, 6, 12, Participant in clinical trials, MSD, 6, Pfizer, 6, UCB, 2, Lilly, 12, Participant in clinical trials; T. Korotaeva, Pfizer, 2, 6, UCB, 2, 6, MSD, 2, 6, Janssen, 2, 6, Novartis, 2, 6, Novartis-Sandoz, 2, 6, BIOCAD, 2, 6, AbbVie, 2, 6, Lilly, 2, 6, Amgen, 2, 6; W. Noël, Janssen, 3, 11; M. Nurmohamed, Pfizer, 2, 5, 6, AbbVie, 2, 5, 6, Roche, 2, 5, 6, Bristol-Myers Squibb, 2, 5, 6, MSD, 2, 5, 6, Mundipharma, 2, 5, 6, UCB, 2, 5, 6, Janssen, 2, 5, 6, Menarini, 2, 5, 6, Lilly, 2, 5, 6, Celgene, 2, 5, 6, Sanofi, 2, 5, 6, Gilead/Galapagos, 2, 5; P. Sfikakis, Actelion, 2, Pfizer, 2, 5, Genesis, 2, MSD, 2, UCB, 2, Boehringer Ingelheim, 2, 5, Enorasis, 2, Farmaserv-Lilly, 2, Gilead, 2, AbbVie, 2, 5, Novartis, 2, Roche, 5, Faran, 5, Amgen, 5, Janssen, 5, Celgene, 2, 5, Lilly, 2, 5; S. Siebert, AbbVie, 5, 6, Biogen, 6, Amgen (previously Celgene), 5, 6, Bristol Myers Squibb, 5, Boehringer-Ingelheim, 5, Novartis, 5, 6, UCB, 5, 6, Janssen, 1, 5, 6, GlaxoSmithKline, 5; E. Theander, Janssen Scientific Affairs, LLC (a subsidiary of Johnson & Johnson), 3, 11; L. Gossec, Galapagos, 5, Sandoz, 5, Sanofi, 5, AbbVie, 2, Amgen, 2, 5, Bristol Myers Squibb, 2, Biogen, 2, Celgene, 2, Eli Lilly, 2, 5, Gilead, 2, Janssen, 2, 5, Novartis, 2, Pfizer, 2, 5, Samsung Bioepis, 2, Sanofi-Aventis, 2, UCB, 2.

To cite this abstract in AMA style:

Smolen J, Bergmans P, de Vlam K, Gremese E, Joven-Ibáñez B, Korotaeva T, Noël W, Nurmohamed M, Sfikakis P, Siebert S, Theander E, Gossec L. Sustained Remission/Low Disease Activity Is Feasible in the Long Term in Patients with Psoriatic Arthritis Treated with IL-23/12 Inhibition with Ustekinumab (STELARA®) and Tumor Necrosis Factor Inhibitors in a Real-World, Multicenter Study [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/sustained-remission-low-disease-activity-is-feasible-in-the-long-term-in-patients-with-psoriatic-arthritis-treated-with-il-23-12-inhibition-with-ustekinumab-stelara-and-tumor-necrosis-factor-i/. Accessed January 27, 2023.
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