Drug Survival of Ustekinumab in Psoriatic Arthritis: A Real-World Multicentric Cohort of 252 Patients

Jean-Guillaume Letarouilly¹, Benoit Flachaire ², Céline Labadie ³, Jérémie Sellam ⁴, Pascal Richette ⁵, Philippe Dieudé ⁶, Pascal Claudepierre ⁷, Bruno Fautrel ⁸, Eric Houvenagel ⁹, Chi Duc Nguyen ¹⁰, Marie-Hélène Guyot ¹¹, Nicolas Segaud ¹², Frédéric Maury ¹³, Laurent Marguerie ¹⁴, Xavier Deprez ¹⁵, Jean-Hugues Salmon ¹⁶, Guy Baudens ¹⁷, Elisabeth Gervais ¹⁸, Isabelle Chary-Valckenaere ¹⁹, Pierre Lafforgue ²⁰, Damien Loeuille ²¹, Christophe Richez ²², Thao Pham ²⁰ and René-Marc Flipo ²³, ¹University of Lille, CHU Lille, department of rheumatology, 59,000 Lille, France, Lille, Nord-Pas-de-Calais, France, ²Aix-Marseille University, CHU Marseille, department of Rheumatology, 13,000 Marseille, France, Marseille, Provence-Alpes-Cote d'Azur, France, ³Bordeaux University, CHU Bordeaux, department of Rheumatology, 33,000 Bordeaux, France, Bordeaux, Aquitaine, France, ⁴Service de Rhumatologie, AP-HP Hôpital Saint-Antoine, Sorbonne Université, INSERM, Centre de Recherche Saint-Antoine, Paris, France, Paris, France, ⁵Department of Rheumatology, AP-HP Lariboisiere Hospital, Paris, France, ⁶Rheumatology, Bichat Hospital, APHP, Paris;, Paris, France, ⁷Rheumatology, CHU Henri Mondor Créteil, Paris, France, ⁸Pitié-Salpêtrière Hospital, Department of Rheumatology, AP-HP, Sorbonne University, UPMC university, Paris, Ile-de-France, France, ⁹Rheumatology, Saint Philibert Hospital, Lille Cathololic Institute, Lomme, Lomme, France, ¹⁰Rheumatology, Hospital of Béthune, Béthune, Béthune, France, ¹¹Rheumatology, Hospital of Roubaix, Roubaix, Roubaix, France, ¹²Internal Medicine, Hospital of Armentières, Armentières, Armentières, France, ¹³Rheumatology, Private Practice, Beuvry, Beuvry, France, ¹⁴Rheumatology, Calot Institute, Berck, Berck-sur-Mer, ¹⁵Rheumatology, Hospital of Valenciennes, Valenciennes, Valenciennes, France, ¹⁶Rheumatology, Reims University Hospital, Reims, Reims, France, ¹⁷Rheumatology, Private Practice, Valenciennes, Valenciennes, France, ¹⁸CHU de Poitiers, Rheumatology, Poitiers, France, ¹⁹Centre Hospitalier Universitaire de Nancy, VANDOEUVRE, France, ²⁰Aix-Marseille University, CHU Marseille, department of Rheumatology, 13,000 Marseille, France, Marseille, France, ²¹Rheumatology, Nancy University Hospital and and UMR 7365 CNRS-UL IMoPA, Université de Lorraine, VANDOEUVRE, France, ²²Pellegrin Hospital, University Hospital of Bordeaux, Bordeaux, France, ²³University of Lille, CHU Lille, department of rheumatology, 59,000 Lille, France, Lille, France

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: Biologic drugs, psoriatic arthritis and multicenter study, survival

Session Information

Date: Monday, November 11, 2019

Title: Spondyloarthritis Including Psoriatic Arthritis – Clinical Poster II: Treatment of Axial Spondyloarthritis & Psoriatic Arthritis

Session Type: Poster Session (Monday)

Session Time: 9:00AM-11:00AM

Background/Purpose: Ustekinumab (UST) is a new biological Disease-modifying AntiRheumatic Drug (bDMARD) available in psoriatic arthritis (PsA), targeting respectively IL12-23. Real-world data are missing for this drug on the contrary to TNF inhibitors. Median drug survival of TNF inhibitors is between 10 and 12 months according to the most recent studies (1).There are only few studies with a low number of patients in UST. Studying drug survival in PsA is important, since new therapies have been launched such IL-17 inhibitors or apremilast.

Methods: This is a retrospective, national, multicentric, non-sponsored by any pharmaceutical company study from patients suffering from PsA (CASPAR criteria or diagnosis confirmed by the rheumatologist) from July 2011 to March 2019. UST has been launched in October 2014. Drug survival was defined as the time from initiation to discontinuation (stop/switch) of bDMARDs. Kaplan-Meier survival curves and Cox-regression analyses [hazard ratios (HR) and 95% confidence intervals (CIs)] were used adjusting for patient demographics, disease characteristics, corticosteroid therapy, co-therapy with methotrexate, previous line of bDMARDs posology of UST and switch to 90 mg every 3 months when patients were at 45 mg every 3 months. Reasons of discontinuation were collected and pooled as primary failure, secondary failure and adverse events. Primary inefficacy was defined as an insufficient response to treatment during the six months after the initiation. Secondary inefficacy was defined as a loss of response to treatment after an initial six-month response.

Results: 252 patients were included with a mean follow-up ≥ 6 months: 183 patients satisfy CASPAR. At baseline, the mean age was 49.2 (11.2) years old. 58% of patients were women. 49% of patients were non-smoker. The body mass index was 28.8 (6.3) kg/m². The disease duration was 10.2 (8.9) years. 44% of patients presented axial and peripheral form. 97% of patients presented psoriasis. The mean Charlson Index was 1.3 (1.5). Patients were bDMARDs-naïve in 22%, had a previous bDMARDs in 16% and more than two bDMARDs in 54% and had co-therapy with methotrexate in 39% and 27% of patients received corticosteroid therapy . Patients had a switch to 90 mg every 3 months in 10%. The mean DAS28-CRP was 3.88 (1.3) and the mean CRP was 27.5 (42.7) mg/L. The median drug survival for UST was 12 months (95%CI: 10-15) (Fig1). Baseline high CRP levels and satisfying CASPAR criteria were associated with a favorable drug survival for UST, respectively (HR=1.007, 95%CI 1.002–1.012 and HR=5.56, 95%CI 2.79-11.13), whereas disease duration and nail psoriasis were associated with an unfavorable one, respectively (HR=0.965, 95%CI 0.00–0.99 and HR=0.52, 95%CI 0.00-0.84). 14 patients under UST stopped their treatment due to side effects.

Conclusion: This real-world study for drug survival on PsA is among the studies with the largest number of patients for UST. Drug survival of UST seems similar to the survival of TNF inhibitors (1).

(1) Walsh JA et al. Care Spec Pharm. 2018;24:623-631

Drug survival of ustekinumab in psoriatic arthritis

Disclosure: J. Letarouilly, None; B. Flachaire, UCB pharma, BMS, Novartis, 9; C. Labadie, None; J. Sellam, Janssen, 8; P. Richette, Janssen, 8; P. Dieudé, None; P. Claudepierre, Janssen, 8; B. Fautrel, AbbVie, 2, 5, 8, Biogen, 5, 8, BMS, 5, 8, Boehringer Ingelheim, 8, Celgene, 5, 8, Eli Lilly and Company, 2, 5, Janssen, 5, 8, Lilly, 8, Medac, 5, 8, MSD, 2, 5, 8, NORDIC Pharma, 5, 8, Novartis, 5, 8, Pfizer, 2, 5, 8, Roche, 5, 8, Sanofi-Aventis, 5, SOBI, 5, 8, UCB, 5, 8; E. Houvenagel, Janssen, 8, Novartis, 8; C. Nguyen, None; M. Guyot, None; N. Segaud, None; F. Maury, None; L. Marguerie, None; X. Deprez, Janssen, 8; J. Salmon, Janssen, 8; G. Baudens, None; E. Gervais, None; I. Chary-Valckenaere, None; P. Lafforgue, Chugai, 8, Amgen, 8, BMS, 8, Lilly, 8, Abbvie, 8, Pfizer, 8, Biogaran, 8; D. Loeuille, None; C. Richez, astrazeneca, 5, 8, BMS, 5, 8, Glenmark, 5, 8, Janssen, 5, 8, Lilly, 5, 8, Pfizer, 5, 8, Roche, 5, 8, UCB, 5, 8; T. Pham, Abbvie, 8, Amgen, 8, Biogen, 8, BMS, 8, Celgene, 8, Fresenius-Kabi, 8, Janssen, 8, Lilly, 8, Medac, 8, MSD, 8, Nordic, 8, Novartis, 8, Pfizer, 8, Roche-Chugai, 8, Sandoz, 8, Sanofi, 8, UCB, 8; R. Flipo, Janssen, 8, Novartis, 8.

To cite this abstract in AMA style:

Letarouilly J, Flachaire B, Labadie C, Sellam J, Richette P, Dieudé P, Claudepierre P, Fautrel B, Houvenagel E, Nguyen C, Guyot M, Segaud N, Maury F, Marguerie L, Deprez X, Salmon J, Baudens G, Gervais E, Chary-Valckenaere I, Lafforgue P, Loeuille D, Richez C, Pham T, Flipo R. Drug Survival of Ustekinumab in Psoriatic Arthritis: A Real-World Multicentric Cohort of 252 Patients [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/drug-survival-of-ustekinumab-in-psoriatic-arthritis-a-real-world-multicentric-cohort-of-252-patients/. Accessed .

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