Florenzo Iannone1, Angelo Semeraro2, Giorgio Carlino3, Leonardo Santo4, Romano Bucci5, Laura Quarta6, Nicola Maruotti7, Carmelo Zuccaro8, Antonio Marsico2, Paola Chiara Francesca Falappone8, Daniela Mazzotta8, Francesco Paolo Cantatore7, Maurizio Muratore6, Giovanni Lapadula9. 1. Rheumatology Unit, Department of Emergency and Organ Transplantation, University of Bari, Pz. G. Cesare, 11, 70124, Bari, Italy. florenzo.iannone@uniba.it. 2. Unità Operativa di Reumatologia ASL Taranto, Viale Virgilio 31, 74121, Taranto, Italy. 3. Rheumatology Service, ASL LE-DSS Casarano-Gallipoli (LE), Lungo Mare Marconi G 1, 73014, Gallipoli, Italy. 4. Unità Operativa di Reumatologia ASL BT, Viale Ippocrate 15, 76121, Barletta, Italy. 5. Rheumatology Hospital Unit, A.O.U. Foggia, Viale Pinto Luigi 251, 71122, Foggia, Italy. 6. U.O. of Rheumatology, "V.Fazzi" Hospital, Lecce, Via Croce di Lecce 10, 73016, San Cesario di Lecce, Italy. 7. UOC Reumatologia Universitaria, University of Foggia, Viale Pinto Luigi 251, 71122, Foggia, Italy. 8. Ambulatorio di Reumatologia Ospedale di Brindisi, Strada Statale Per Mesagne 7, 72100, Brindisi, Italy. 9. Rheumatology Unit, Department of Emergency and Organ Transplantation, University of Bari, Pz. G. Cesare, 11, 70124, Bari, Italy.
Abstract
BACKGROUND: Identification of predictors of clinical response to certolizumab-pegol (certolizumab) may aid the decision-making process for treating patients with rheumatoid arthritis (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA). OBJECTIVE: The aim of our study was to evaluate the effectiveness of certolizumab and identify any predictors of favorable outcome in patients with RA, PsA, or SpA. METHODS: We studied 355 RA, SpA, and PsA patients starting treatment with certolizumab. Endpoints of the study were drug survival and identification of predictors of clinical outcome. Drug retention was analyzed via the Kaplan-Meier method, and hazard ratios (HRs) were estimated using Cox regression models. RESULTS: Of 355 certolizumab initiators, 178 had RA, 94 had PsA, and 83 had SpA. Biologic-naïve RA patients had significantly higher survival rates (73.3%) than switchers taking certolizumab as a second-line (49.0%) or third- or next-line biologic agent (51.2%; p = 0.0001). Instead, PsA and SpA patients showed similar drug retention rates regardless of the line of treatment. A significant clinical improvement from baseline was seen at 3 months for RA (28 joint-Disease Activity Score [DAS28]; p = 0.001), PsA (Disease Activity Index for PsA [DAPSA]; p = 0.001), and SpA (Bath Ankylosing Disease Index; p = 0.01). Biologic-naïve patients had the lowest HR (0.31; p = 0.001) of discontinuing certolizumab for RA, and the highest HR (7.94; p = 0.01) of achieving minimal disease activity (MDA) for PsA. For PsA, a predictor of late MDA was the achievement of low/remission DAPSA at 3 months, and 3-month low/remission DAS28 predicted late remission for RA. CONCLUSIONS: Our study revealed that the best predictor of certolizumab effectiveness in unselected patients with RA, PsA, or SpA was a biologic-naïve status and achievement of an early response within 3 months.
BACKGROUND: Identification of predictors of clinical response to certolizumab-pegol (certolizumab) may aid the decision-making process for treating patients with rheumatoid arthritis (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA). OBJECTIVE: The aim of our study was to evaluate the effectiveness of certolizumab and identify any predictors of favorable outcome in patients with RA, PsA, or SpA. METHODS: We studied 355 RA, SpA, and PsA patients starting treatment with certolizumab. Endpoints of the study were drug survival and identification of predictors of clinical outcome. Drug retention was analyzed via the Kaplan-Meier method, and hazard ratios (HRs) were estimated using Cox regression models. RESULTS: Of 355 certolizumab initiators, 178 had RA, 94 had PsA, and 83 had SpA. Biologic-naïve RApatients had significantly higher survival rates (73.3%) than switchers taking certolizumab as a second-line (49.0%) or third- or next-line biologic agent (51.2%; p = 0.0001). Instead, PsA and SpA patients showed similar drug retention rates regardless of the line of treatment. A significant clinical improvement from baseline was seen at 3 months for RA (28 joint-Disease Activity Score [DAS28]; p = 0.001), PsA (Disease Activity Index for PsA [DAPSA]; p = 0.001), and SpA (Bath Ankylosing Disease Index; p = 0.01). Biologic-naïve patients had the lowest HR (0.31; p = 0.001) of discontinuing certolizumab for RA, and the highest HR (7.94; p = 0.01) of achieving minimal disease activity (MDA) for PsA. For PsA, a predictor of late MDA was the achievement of low/remission DAPSA at 3 months, and 3-month low/remission DAS28 predicted late remission for RA. CONCLUSIONS: Our study revealed that the best predictor of certolizumab effectiveness in unselected patients with RA, PsA, or SpA was a biologic-naïve status and achievement of an early response within 3 months.
Authors: Proton Rahman; Philip Baer; Ed Keystone; Denis Choquette; Carter Thorne; Boulos Haraoui; Andrew Chow; Rafat Faraawi; Wojciech Olszynski; John Kelsall; Emmanouil Rampakakis; Allen J Lehman; Francois Nantel Journal: BMC Rheumatol Date: 2020-09-19
Authors: Pedro Santos-Moreno; Susan Martinez; Linda Ibatá; Laura Villarreal; Manuel Rivero; Adriana Rojas-Villarraga Journal: Biologics Date: 2021-10-22