Background Long-term registries are essential to evaluate new therapies in a patient population that differs from clinical trials and usually varies over time.
Objectives To describe the profile of psoriatic arthritis (PsA) patients selected for treatment with infliximab (IFX), golimumab (GLM) or ustekinumab (UST) treatment in Canadian routine care and to describe the long-term real-world effectiveness and safety of these agents.
Methods 462 PsA patients treated with IFX, GLM or UST were enrolled into the Biologic Treatment Registry Across Canada (BioTRAC) registry between 2006-2015, 2010-2017 and 2014-2017, respectively. Study visits occurred at baseline and every 6 months thereafter. Effectiveness was assessed with changes in TJC28, SJC28, skin, enthesitis, dactylitis, pain, HAQ, acute phase reactants. Safety was evaluated with the incidence of adverse events (AEs) and drug survival rates.
Results Of the 111 IFX-, 281 GLM- and 70 UST-treated patients, the proportion of males were 52.3%, 46.3% and 37.1%, the mean age was 48.4, 52.8 and 53.1 years and the mean disease duration was 5.8, 6.1 and 5.7 years, respectively. Most patients were bio-naive (85.6%, 77.9% and 55.7% for IFX, GLM and UST, respectively (p<0.001). A reduction in mean baseline duration of morning stiffness was observed in the IFX cohort (from 69.8 to 42.6 to 23 min in 2006-2008 to 2009-2012 to 2013-2015; p=0.003). Most other baseline disease parameters remained similar over time in all three cohorts. However, UST-treated patients had lower mean baseline DAS28 CRP (3.4 vs 3.9; p=0.0031), SJC (3.8 vs 5.3; p=0.0046) and higher PASI (4.8 vs 2.2; p=0.0061) compared to patients treated with GLM.
Treatment with IFX, GLM and UST was associated with significant improvements in all disease parameters over time (P<0.001) from baseline up to 84, 84 and 40 months, respectively with similar efficacy between agents. The only exception was the proportion of patients in minimal disease activity at 12, 24 and 36 months which reached 40.7%, 50.0% and 55% in IFX-patients; 64.7%, 68.8% and 78.9% in GLM-patients and 58.8%, 60.0% and 83.3% in UST-patients (p=0.004 and p<0.001 vs IFX).
AEs were reported for 74.8%, 69.8% and 52.9% (138, 114 and 115 events/100 PYs) and SAEs for 19.8%, 8.5% and 5.7% (8.8, 19.6 and 28.6 events/100 PYs) covering 325, 567 and 87 years of exposure for IFX-, GLM- and UST-treated patients, respectively. One, one and no death occurred IFX-, GLM- and UST-treated patients, respectively. The proportion of patients who discontinued treatment were 63.1%, 50.9% and 50.0% over a mean exposure of 2.9, 1.9 and 1.2 years to IFX, GLM and UST, respectively.
Conclusion Differences in baseline characteristics between patients treated with an anti-TNF over an anti-IL12/23 agent suggest that the level of joint to skin involvement might be driving physician choice when the time comes to choose a biologic agent. IFX, GLM and UST treatment significantly reduced disease activity and improved functionality in a similar fashion and were well tolerated in patients with PsA.
Disclosure of Interests Proton Rahman: None declared, Regan Arendse Grant/research support from: Janssen Sponsored Study, Isabelle Fortin Grant/research support from: ABBVIE, AMGEN, ASTRAZENECA, BMS, CELGENE, GSK, JANSSEN, PFIZER, SANOFI, UCB, Consultant for: LILLY, NOVARTIS, SANOFI, Speakers bureau: NOVARTIS, PFIZER, Andrew Chow Grant/research support from: Abbvie, Celgene, EliLilly, GSK, Janssen, Novartis, Pfizer, UCB, Consultant for: Abbvie, BMS, Celgene, EliLilly, GSK, Janssen, Novartis, Pfizer, Roche,UCB, Speakers bureau: Abbvie, BMS, EliLilly, Janssen, Novartis, Pfizer, Majed Khraishi Grant/research support from: Novartis, Consultant for: Amgen, Celgene, Gebro, Janssen, Novartis, Pfizer, Lilly, Merck, Suneil Kapur Grant/research support from: Abbvie, Merck, Janssen, Novartis, Eli Lilly, Amgen, Michel Zummer: None declared, Jon Chan Grant/research support from: Janssen, UCB, Novartis, Pfizer, Celgene, Consultant for: Amgen, Celgene, Eli Lilly, Janssen, Amgen, Abbvie, Novartis, Pfizer, UCB, Sandoz, Merck, Larissa Lisnevskaia Grant/research support from: Janssen Sponsored Study, Raheem Kherani Grant/research support from: Janssen, BMS, Abbvie, Consultant for: Abbvie, Amgen, BMS, Janssen, Lilly, Merck, Pfizer, Roche, Speakers bureau: Jannsen, BMS, Emmanouil Rampakakis : None declared, Odalis Asin MIilan Employee of: Employee of Janssen, Allen Lehman Employee of: Employee of Janssen, Meagan Rachich Shareholder of: Janssen, Employee of: Employee of Janssen, Francois Nantel Shareholder of: Janssen, Employee of: Employee of Janssen
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