Comparison of efficacy of first- versus second-line adalimumab in patients with rheumatoid arthritis: Experience of the Italian biologics registries

Veronica Codullo, Florenzo Iannone, Luigi Sinigaglia, Ennio Giulio Favalli, Piercarlo Sarzi-Puttini, Fabiola Atzeni, Gianfranco Ferraccioli, Elisa Gremese, Antonio Carletto, Alessandro Giollo, Marcello Govoni, Francesca Bergossi, Mauro Galeazzi, Luca Cantarini, Fausto Salaffi, Marco Di Carlo, Chiara Bazzani, Raffaele Pellerito, Marco Sebastiani, Roberta RamondaGiovanni Lapadula, Roberto Caporali

Research output: Contribution to journalArticle

Abstract

Objective Targeted drugs against key pathogenetic molecules such as TNF-alpha have significantly improved outcomes in rheumatoid arthritis (RA). They are widely used in clinical practice and drug registries give us information to support their use. Adalimumab (ADA) is able to induce a comprehensive disease control in RA by achieving clinical, functional and radiographic control. Methods By interrogating 2 Italian registries, LORHEN and GISEA, we analysed the efficacy of ADA in first- or second-line in a total of 2262 RA patients. Results Patients in 1st line were significantly older, with lower disease activity and HAQ scores compared to 2nd line. In 1st line, rates of DAS28-remission (DAS28rem) at 2 years were 34.4% while 26.5% in 2nd line (p=0.038). A normal HAQ score (HAQ≤0.5) was achieved in 53.5% after 2 years in 1st line versus 30.1% in 2nd (p < 0.0001). DAS28rem+HAQ≤0.5, a combined parameter that we defined global clinical disease control, was reached in 20.7% in 1st line versus 13.3% in 2nd (p < 0.01). Five-year-survival on therapy was higher for patients in 1st line (45.6% vs. 33.2%, p < 0.0001). Discontinuation due to lack of efficacy was lower in 1st line (37.4 vs. 54.4%, p < 0.0001). Rates of adverse events were similar. Conclusion Responses in 1st line are generally significantly better than after a first anti-TNF-alpha failure but patients in 2nd line have a worse clinical and functional profile. A global disease control with clinical and functional remission is an achievable target in both lines.

Original languageEnglish
Pages (from-to)660-665
Number of pages6
JournalClinical and Experimental Rheumatology
Volume35
Issue number4
Publication statusPublished - Jan 1 2017

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ametantrone
Biological Products
Registries
Rheumatoid Arthritis
Tumor Necrosis Factor-alpha
Pharmaceutical Preparations
Survival
Adalimumab
Therapeutics

Keywords

  • Adalimumab
  • HAQ
  • Remission
  • Rheumatoid arthritis

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

Cite this

Comparison of efficacy of first- versus second-line adalimumab in patients with rheumatoid arthritis : Experience of the Italian biologics registries. / Codullo, Veronica; Iannone, Florenzo; Sinigaglia, Luigi; Favalli, Ennio Giulio; Sarzi-Puttini, Piercarlo; Atzeni, Fabiola; Ferraccioli, Gianfranco; Gremese, Elisa; Carletto, Antonio; Giollo, Alessandro; Govoni, Marcello; Bergossi, Francesca; Galeazzi, Mauro; Cantarini, Luca; Salaffi, Fausto; Di Carlo, Marco; Bazzani, Chiara; Pellerito, Raffaele; Sebastiani, Marco; Ramonda, Roberta; Lapadula, Giovanni; Caporali, Roberto.

In: Clinical and Experimental Rheumatology, Vol. 35, No. 4, 01.01.2017, p. 660-665.

Research output: Contribution to journalArticle

Codullo, V, Iannone, F, Sinigaglia, L, Favalli, EG, Sarzi-Puttini, P, Atzeni, F, Ferraccioli, G, Gremese, E, Carletto, A, Giollo, A, Govoni, M, Bergossi, F, Galeazzi, M, Cantarini, L, Salaffi, F, Di Carlo, M, Bazzani, C, Pellerito, R, Sebastiani, M, Ramonda, R, Lapadula, G & Caporali, R 2017, 'Comparison of efficacy of first- versus second-line adalimumab in patients with rheumatoid arthritis: Experience of the Italian biologics registries', Clinical and Experimental Rheumatology, vol. 35, no. 4, pp. 660-665.
Codullo, Veronica ; Iannone, Florenzo ; Sinigaglia, Luigi ; Favalli, Ennio Giulio ; Sarzi-Puttini, Piercarlo ; Atzeni, Fabiola ; Ferraccioli, Gianfranco ; Gremese, Elisa ; Carletto, Antonio ; Giollo, Alessandro ; Govoni, Marcello ; Bergossi, Francesca ; Galeazzi, Mauro ; Cantarini, Luca ; Salaffi, Fausto ; Di Carlo, Marco ; Bazzani, Chiara ; Pellerito, Raffaele ; Sebastiani, Marco ; Ramonda, Roberta ; Lapadula, Giovanni ; Caporali, Roberto. / Comparison of efficacy of first- versus second-line adalimumab in patients with rheumatoid arthritis : Experience of the Italian biologics registries. In: Clinical and Experimental Rheumatology. 2017 ; Vol. 35, No. 4. pp. 660-665.
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abstract = "Objective Targeted drugs against key pathogenetic molecules such as TNF-alpha have significantly improved outcomes in rheumatoid arthritis (RA). They are widely used in clinical practice and drug registries give us information to support their use. Adalimumab (ADA) is able to induce a comprehensive disease control in RA by achieving clinical, functional and radiographic control. Methods By interrogating 2 Italian registries, LORHEN and GISEA, we analysed the efficacy of ADA in first- or second-line in a total of 2262 RA patients. Results Patients in 1st line were significantly older, with lower disease activity and HAQ scores compared to 2nd line. In 1st line, rates of DAS28-remission (DAS28rem) at 2 years were 34.4{\%} while 26.5{\%} in 2nd line (p=0.038). A normal HAQ score (HAQ≤0.5) was achieved in 53.5{\%} after 2 years in 1st line versus 30.1{\%} in 2nd (p < 0.0001). DAS28rem+HAQ≤0.5, a combined parameter that we defined global clinical disease control, was reached in 20.7{\%} in 1st line versus 13.3{\%} in 2nd (p < 0.01). Five-year-survival on therapy was higher for patients in 1st line (45.6{\%} vs. 33.2{\%}, p < 0.0001). Discontinuation due to lack of efficacy was lower in 1st line (37.4 vs. 54.4{\%}, p < 0.0001). Rates of adverse events were similar. Conclusion Responses in 1st line are generally significantly better than after a first anti-TNF-alpha failure but patients in 2nd line have a worse clinical and functional profile. A global disease control with clinical and functional remission is an achievable target in both lines.",
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T1 - Comparison of efficacy of first- versus second-line adalimumab in patients with rheumatoid arthritis

T2 - Experience of the Italian biologics registries

AU - Codullo, Veronica

AU - Iannone, Florenzo

AU - Sinigaglia, Luigi

AU - Favalli, Ennio Giulio

AU - Sarzi-Puttini, Piercarlo

AU - Atzeni, Fabiola

AU - Ferraccioli, Gianfranco

AU - Gremese, Elisa

AU - Carletto, Antonio

AU - Giollo, Alessandro

AU - Govoni, Marcello

AU - Bergossi, Francesca

AU - Galeazzi, Mauro

AU - Cantarini, Luca

AU - Salaffi, Fausto

AU - Di Carlo, Marco

AU - Bazzani, Chiara

AU - Pellerito, Raffaele

AU - Sebastiani, Marco

AU - Ramonda, Roberta

AU - Lapadula, Giovanni

AU - Caporali, Roberto

PY - 2017/1/1

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N2 - Objective Targeted drugs against key pathogenetic molecules such as TNF-alpha have significantly improved outcomes in rheumatoid arthritis (RA). They are widely used in clinical practice and drug registries give us information to support their use. Adalimumab (ADA) is able to induce a comprehensive disease control in RA by achieving clinical, functional and radiographic control. Methods By interrogating 2 Italian registries, LORHEN and GISEA, we analysed the efficacy of ADA in first- or second-line in a total of 2262 RA patients. Results Patients in 1st line were significantly older, with lower disease activity and HAQ scores compared to 2nd line. In 1st line, rates of DAS28-remission (DAS28rem) at 2 years were 34.4% while 26.5% in 2nd line (p=0.038). A normal HAQ score (HAQ≤0.5) was achieved in 53.5% after 2 years in 1st line versus 30.1% in 2nd (p < 0.0001). DAS28rem+HAQ≤0.5, a combined parameter that we defined global clinical disease control, was reached in 20.7% in 1st line versus 13.3% in 2nd (p < 0.01). Five-year-survival on therapy was higher for patients in 1st line (45.6% vs. 33.2%, p < 0.0001). Discontinuation due to lack of efficacy was lower in 1st line (37.4 vs. 54.4%, p < 0.0001). Rates of adverse events were similar. Conclusion Responses in 1st line are generally significantly better than after a first anti-TNF-alpha failure but patients in 2nd line have a worse clinical and functional profile. A global disease control with clinical and functional remission is an achievable target in both lines.

AB - Objective Targeted drugs against key pathogenetic molecules such as TNF-alpha have significantly improved outcomes in rheumatoid arthritis (RA). They are widely used in clinical practice and drug registries give us information to support their use. Adalimumab (ADA) is able to induce a comprehensive disease control in RA by achieving clinical, functional and radiographic control. Methods By interrogating 2 Italian registries, LORHEN and GISEA, we analysed the efficacy of ADA in first- or second-line in a total of 2262 RA patients. Results Patients in 1st line were significantly older, with lower disease activity and HAQ scores compared to 2nd line. In 1st line, rates of DAS28-remission (DAS28rem) at 2 years were 34.4% while 26.5% in 2nd line (p=0.038). A normal HAQ score (HAQ≤0.5) was achieved in 53.5% after 2 years in 1st line versus 30.1% in 2nd (p < 0.0001). DAS28rem+HAQ≤0.5, a combined parameter that we defined global clinical disease control, was reached in 20.7% in 1st line versus 13.3% in 2nd (p < 0.01). Five-year-survival on therapy was higher for patients in 1st line (45.6% vs. 33.2%, p < 0.0001). Discontinuation due to lack of efficacy was lower in 1st line (37.4 vs. 54.4%, p < 0.0001). Rates of adverse events were similar. Conclusion Responses in 1st line are generally significantly better than after a first anti-TNF-alpha failure but patients in 2nd line have a worse clinical and functional profile. A global disease control with clinical and functional remission is an achievable target in both lines.

KW - Adalimumab

KW - HAQ

KW - Remission

KW - Rheumatoid arthritis

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