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Retrospective evaluation of patient profiling and effectiveness of apremilast in an Italian multicentric cohort of psoriatic arthritis patients

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18

  1. Department of Rheumatology, Gaetano Pini Institute, Milan, Italy. ennio.favalli@gmail.com
  2. Sapienza Arthritis Center, Dipartimento Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Italy.
  3. Rheumatology, Humanitas Research Hospital, Rozzano, Italy.
  4. DETO-Rheumatology Unit, University of Bari, Italy.
  5. Rheumatology Hospital Unit, A.O.U. “OO.RR. Foggia”, Italy.
  6. UOC Reumatologia Universitaria, University of Foggia, Italy.
  7. Rheumatology Service, ASL Lecce - DSS Casarano and Gallipoli, Italy.
  8. Rheumatology Service, DSS4 Barletta ASL BT Andria, Italy.
  9. UO of Rheumatology, ASL Taranto, Italy.
  10. Hospital Outpatient clinic of Rheumatology, ASL BR, Brindisi, Italy.
  11. Rheumatology Department of Lucania, San Carlo Hospital of Potenza and Madonna delle Grazie Hospital of Matera, Italy.
  12. Rheumatology, University of Messina, Italy.
  13. Rheumatology, University of Messina, Italy.
  14. Department of Rheumatology, University of Pavia, IRCCS Policlinico San Matteo Foundation, Pavia, Italy.
  15. Rheumatology, Humanitas Research Hospital, Rozzano, Italy.
  16. Sapienza Arthritis Center, Dipartimento Medicina Interna e Specialità Mediche, Sapienza Università di Roma, Italy.
  17. Department of Rheumatology, Gaetano Pini Institute, Milan, Italy.
  18. Department of Rheumatology, University of Pavia, IRCCS Policlinico San Matteo Foundation, Pavia, Italy.

CER11692 Submission on line
Full Papers

Rheumatology Article

 

Abstract

OBJECTIVES:
We aimed to evaluate the baseline characteristics, the reasons for prescription, and the effectiveness/safety profile of real-life apremilast for the treatment of psoriatic arthritis (PsA).
METHODS:
PsA patients treated with apremilast were retrospectively extracted from an Italian multicentric cohort. Baseline population characteristics and reasons for apremilast prescription were analysed. Clinical response was defined as the proportion of patients achieving Disease Activity in PSoriatic Arthritis (DAPSA) remission/low disease activity (LDA), minimal disease activity (MDA), and very low disease activity (VLDA). Six-month retention rate was computed by the Kaplan-Meier method, with a detailed analysis of reasons for discontinuation. Univariate and multivariate models were developed to examine predictors of clinical response and persistence.
RESULTS:
The study population included 131 patients mainly with oligoarticular PsA (58%), carrying at least one comorbidity (64.1%, in particular history of malignancies [25.9%] and latent tuberculosis [16.3%]) treated with apremilast as first-line targeted therapy (47.7%) or in biologics failures (52.3%). Contraindication to biologics (60.3%) and lack of poor prognostic factors (27.5%) were the most frequent reason for apremilast prescription. The 6-month retention rate was 72.1%. Inefficacy (n=7), diarrhoea (n=10), nausea (n=3), and headache (n=7) were the most frequent reasons for discontinuation. At 3 months DAPSA LDA/remission, MDA, and VLDA were observed in 40.3, 6.7, and 5.6% of patients, respectively. Female sex was a negative predictor of both retention rate and clinical response.
CONCLUSIONS:
In our real-life analysis apremilast was mainly used in oligoarticular PsA carrying comorbidities leading to contraindications to biologics. Effectiveness and safety profiles were consistent with clinical trials.

PMID: 31074721 [PubMed]

Received: 02/09/2018 - Accepted : 25/02/2019 - In Press: 10/05/2019