Elsevier

Joint Bone Spine

Volume 82, Issue 1, January 2015, Pages 31-37
Joint Bone Spine

Original article
Treatment response, drug survival and safety of anti-tumour necrosis factor α therapy in 193 patients with psoriatic arthritis: A twelve-year “real life” experience

https://doi.org/10.1016/j.jbspin.2014.08.001Get rights and content

Abstract

Objective

To evaluate the performance of anti-TNFα therapy in psoriatic arthritis (PsA) in a routine care setting.

Methods

Inclusion criteria were patients with PsA who initiated anti-TNFα therapy between April 2001 and April 2013 with a follow-up of at least 6 months. For peripheral forms, treatment was considered to be effective for patients with a favourable expert opinion or > 30% clinical improvement of swollen and tender joint counts. For axial forms, efficacy criteria were: improvement of BASDAI by at least 2 points on a scale from 0 to 10 or 50% improvement (BASDAI 50) or expert opinion. Drug survival of first anti-TNFα therapy was also investigated.

Results

The study included 193 patients (107/86 M/F, mean age: 46.8 years, mean disease duration: 6.7 years, 171/22 peripheral/axial forms). Only 48 (25%) patients received concomitant DMARD therapy (65% were treated with methotrexate). The majority of patients started with first-line etanercept (n = 102), followed by adalimumab (n = 46), infliximab (n = 44) and golimumab (n = 1). At 3 months, 90% of patients had obtained an adequate response, 7% had discontinued due to lack of efficacy and 3% due to adverse events. Median drug survival was 2 years. One-year and 2-year drug survival rates were 77% and 67%, respectively. Seventy-nine (41%) patients switched to a second anti-TNFα and 29 to a third anti-TNFα; 82% of switchers responded to second-line therapy and 83% responded to third-line therapy.

Conclusion

High drug survival and high response rates were observed in these patients with PsA receiving their first anti-TNFα therapy in routine clinical practice.

Introduction

Psoriatic arthritis (PsA) is a form of spondyloarthritis. The therapeutic approach is essentially multidisciplinary and must take rheumatological as well as dermatological aspects into account [1], [2], [3]. Non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids (systemic or intra-articular) have a place in the treatment of PsA together with cs-DMARDs (methotrexate, leflunomide, sulfasalazine) for the treatment of peripheral forms of the disease [1], [2], [3]. Following failure of cs-DMARDs or in predominantly axial forms, anti-TNFα therapy constitutes the reference biotherapy for the treatment of PsA [1], [2], [3]. The clinical and structural efficacy of anti-TNFα therapy was demonstrated during therapeutic trials and five anti-TNFα drugs are currently marketed in France for the treatment of PsA: etanercept (soluble receptor) [4], [5], [6], infliximab (chimeric monoclonal antibody) [7], [8], [9], [10], adalimumab (humanised monoclonal antibody) [11], golimumab (humanised monoclonal antibody) [12], [13] and certolizumab (pegylated monoclonal antibody) [14].

Clinical experience acquired from patient registries or so-called “real life” studies provides valuable information to assess routine management of PsA by anti-TNFα and can be used to validate the results obtained during therapeutic trials in populations of older patients with multiple comorbidities. Several national registries are available: DANBIO for Denmark [15], [16], NOR-DMARD for Norway [17], [18], BSR-BR for England [19], and SSATG for Sweden [20]. However, the available data remain fairly limited, based on relatively short patient follow-up with sometimes contradictory results and conclusions, particularly concerning the value of switching anti-TNFα [16], [17] and the relevance of concomitant treatment with methotrexate and an anti-TNFα at the time of initiation especially to achieve better drug survival [18], [20].

The objective of this study was to evaluate the “real life” use of anti-TNFα therapy for the management of PsA in a large patient cohort with a maximum duration of follow-up of 10 years, with particular emphasis on efficacy, drug survival, safety and predictive factors of discontinuation of first-line anti-TNFα therapy.

Section snippets

Patients

This single centre, retrospective, observational study was conducted from April 2001 to April 2013. The charts of all patients with PsA treated with at least one anti-TNFα drug for more than 6 months were reviewed. Patient charts were retrieved from the health informatics department. Moll and Wright and/or CASPAR criteria were used to establish the diagnosis of PsA [21], [22]. In doubtful cases, the final diagnosis was validated by the use of the new ASAS criteria for axial and peripheral

Patient characteristics at the time of initiation of first-line anti-TNFα therapy

More than one half of the 193 patients with PsA who had received treatment with at least one anti-TNFα drug were men (55%). The mean age was 46.8 years with a mean history of disease of 6.7 years (Table 1). These patients predominantly presented peripheral forms in 89% of cases. The great majority of patients (83%) reported a personal history of psoriasis of the skin and/or nails. Patients had received a mean of slightly more than 2 cs-DMARDs (mean: 2.5 ± 1.8) before initiation of first-line

Discussion

This cohort of 193 patients, with a maximum duration of follow-up of 10 years, provides valuable information concerning the use of anti-TNFα drugs for the treatment of PsA. Based on the use of pragmatic criteria, this study demonstrated a high response rate at 3 months and satisfactory drug survival rates for first-line, as well as second-line and third-line anti-TNFα therapy, thereby confirming the value of treatment switch. On the other hand, the value of co-prescription of cs-DMARDs at the

Disclosure of interest

The authors declare that they have no conflicts of interest concerning this article.

Acknowledgements

This study was supported by a grant from Pfizer.

References (43)

  • C.E. Antoni et al.

    Two-year efficacy and safety of infliximab treatment in patients with active psoriatic arthritis: findings of the Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT)

    J Rheumatol

    (2008)
  • A. Kavanaugh et al.

    The Infliximab Multinational Psoriatic Arthritis Controlled Trial (IMPACT): results of radiographic analyses after 1 year

    Ann Rheum Dis

    (2006)
  • A. Kavanaugh et al.

    Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: results from the IMPACT 2 trial

    Ann Rheum Dis

    (2007)
  • D. van der Heijde et al.

    Infliximab inhibits progression of radiographic damage in patients with active psoriatic arthritis through one year of treatment: Results from the induction and maintenance psoriatic arthritis clinical trial 2

    Arthritis Rheum

    (2007)
  • P.J. Mease et al.

    Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomized, placebo-controlled trial

    Arthritis Rheum

    (2005)
  • A. Kavanaugh et al.

    Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: twenty-four-week efficacy and safety results of a randomized, placebo-controlled study

    Arthritis Rheum

    (2009)
  • A. Kavanaugh et al.

    Long-term radiographic outcome in psoriatic arthritis patients treated with golimumab: 104 week results from the GO-REVEAL Study

    Arthritis Rheum

    (2010)
  • B. Glintborg et al.

    Treatment response, drug survival, and predictors thereof in 764 patients with psoriatic arthritis treated with anti-tumor necrosis factor α therapy: results from the nationwide Danish DANBIO registry

    Arthritis Rheum

    (2011)
  • B. Glintborg et al.

    Clinical response, drug survival, and predictors thereof among 548 patients with psoriatic arthritis who switched tumor necrosis factor α inhibitor therapy: results from the Danish Nationwide DANBIO Registry

    Arthritis Rheum

    (2013)
  • K.M. Fagerli et al.

    Switching between TNF inhibitors in psoriatic arthritis: data from the NOR-DMARD study

    Ann Rheum Dis

    (2013)
  • K.M. Fagerli et al.

    The role of methotrexate co-medication in TNF-inhibitor treatment in patients with psoriatic arthritis: results from 440 patients included in the NOR-DMARD study

    Ann Rheum Dis

    (2014)
  • Cited by (25)

    • Switching biologics in the treatment of psoriatic arthritis

      2017, Seminars in Arthritis and Rheumatism
    View all citing articles on Scopus
    View full text