Objective: To investigate the efficacy and safety of ixekizumab in patients with active radiographic axial spondyloarthritis (SpA) and prior inadequate response to or intolerance of 1 or 2 tumor necrosis factor inhibitors (TNFi). Methods: In this phase III randomized, double-blind, placebo-controlled trial, adult patients with an inadequate response to or intolerance of 1 or 2 TNFi and an established diagnosis of axial SpA (according to the Assessment of SpondyloArthritis international Society [ASAS] criteria for radiographic axial SpA, with radiographic sacroiliitis defined according to the modified New York criteria and ≥1 feature of SpA) were recruited and randomized 1:1:1 to receive placebo or 80-mg subcutaneous ixekizumab every 2 weeks (IXEQ2W) or 4 weeks (IXEQ4W), with an 80-mg or 160-mg starting dose. The primary end point was 40% improvement in disease activity according to the ASAS criteria (ASAS40) at week 16. Secondary outcomes and safety were also assessed. Results: A total of 316 patients were randomized to receive placebo (n = 104), IXEQ2W (n = 98), or IXEQ4W (n = 114). At week 16, significantly higher proportions of IXEQ2W patients (n = 30 [30.6%]; P = 0.003) or IXEQ4W patients (n = 29 [25.4%]; P = 0.017) had achieved an ASAS40 response versus the placebo group (n = 13 [12.5%]), with statistically significant differences reported as early as week 1 with ixekizumab treatment. Statistically significant improvements in disease activity, function, quality of life, and spinal magnetic resonance imaging–evident inflammation were observed after 16 weeks of ixekizumab treatment versus placebo. Treatment-emergent adverse events (AEs) with ixekizumab treatment were more frequent than with placebo. Serious AEs were similar across treatment arms. One death was reported (IXEQ2W group). Conclusion: Ixekizumab treatment for 16 weeks in patients with active radiographic axial SpA and previous inadequate response to or intolerance of 1 or 2 TNFi yields rapid and significant improvements in the signs and symptoms of radiographic axial SpA versus placebo.
Deodhar, A., Poddubnyy, D., Pacheco-Tena, C., Salvarani, C., Lespessailles, E., Rahman, P., Järvinen, P., Sanchez-Burson, J., Gaffney, K., Lee, E. B., Krishnan, E., Santisteban, S., Li, X., Zhao, F., Carlier, H., Reveille, J. D., Antolini, C., Azevedo, V., Barkham, M., Rodriguez, A. A. B., Berman, A., Blicharski, T., Brzezicki, J., Burmester, G., Carrio, J., Collantes, E., Combe, B., Cons-Molina, F., Cortes-Maisonet, G., Dudek, A., Barragan, S. D., Elkayam, O., Flint, K., Galeazzi, M., Gaylis, N., Goddard, D., Fernandez, C. G., Goupille, P., Masmitja, J. G., Greenwald, M., Gremese, E., Hong, S. J., Howell, M., Hrycaj, P., Ince, A., Ju, J. H., Kaine, J., Kang, S. W., Keiserman, M., Kim, T., Kivitz, A., Klein, S., Kremer, J., Lee, S. H., Lee, C. K., Lee, S., Lidman, R., Loveless, J., Lucero, E., Cocco, J. M., Marcolino, F., Mariette, X., Mehta, D., Morin, F., Moscovici, Y., Mueller, E., Mysler, E., Blasco, F. N., Nguyen, M., Pantojas, C., Park, M., Jesus, A. P., Peters, E., Plebanski, R., Querubin, R., Remus, C. R., Reitblat, T., Rivera, T., Rodriguez, J. C. R., Sayers, M., Scotton, A., Scoville, C., Shaw, D., Shin, K., Singhal, A., Skinner, C., Soto-Raices, O., Soubrier, M., Szymanska, M., Thai, C., Van De Sande, M., Wells, A., Wojciechowski, R., Xavier, R., Ximenes, A., Zisman, D., Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo–Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors, <<ARTHRITIS & RHEUMATOLOGY>>, 2019; 71 (4): 599-611. [doi:10.1002/art.40753] [http://hdl.handle.net/10807/132770]
Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo–Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors
Gremese, Elisa;
2019
Abstract
Objective: To investigate the efficacy and safety of ixekizumab in patients with active radiographic axial spondyloarthritis (SpA) and prior inadequate response to or intolerance of 1 or 2 tumor necrosis factor inhibitors (TNFi). Methods: In this phase III randomized, double-blind, placebo-controlled trial, adult patients with an inadequate response to or intolerance of 1 or 2 TNFi and an established diagnosis of axial SpA (according to the Assessment of SpondyloArthritis international Society [ASAS] criteria for radiographic axial SpA, with radiographic sacroiliitis defined according to the modified New York criteria and ≥1 feature of SpA) were recruited and randomized 1:1:1 to receive placebo or 80-mg subcutaneous ixekizumab every 2 weeks (IXEQ2W) or 4 weeks (IXEQ4W), with an 80-mg or 160-mg starting dose. The primary end point was 40% improvement in disease activity according to the ASAS criteria (ASAS40) at week 16. Secondary outcomes and safety were also assessed. Results: A total of 316 patients were randomized to receive placebo (n = 104), IXEQ2W (n = 98), or IXEQ4W (n = 114). At week 16, significantly higher proportions of IXEQ2W patients (n = 30 [30.6%]; P = 0.003) or IXEQ4W patients (n = 29 [25.4%]; P = 0.017) had achieved an ASAS40 response versus the placebo group (n = 13 [12.5%]), with statistically significant differences reported as early as week 1 with ixekizumab treatment. Statistically significant improvements in disease activity, function, quality of life, and spinal magnetic resonance imaging–evident inflammation were observed after 16 weeks of ixekizumab treatment versus placebo. Treatment-emergent adverse events (AEs) with ixekizumab treatment were more frequent than with placebo. Serious AEs were similar across treatment arms. One death was reported (IXEQ2W group). Conclusion: Ixekizumab treatment for 16 weeks in patients with active radiographic axial SpA and previous inadequate response to or intolerance of 1 or 2 TNFi yields rapid and significant improvements in the signs and symptoms of radiographic axial SpA versus placebo.
| File | Dimensione | Formato | |
|---|---|---|---|
|
132770OA.pdf
accesso aperto
Tipologia file ?:
Versione Editoriale (PDF)
Licenza:
Creative commons
Dimensione
674.58 kB
Formato
Unknown
|
674.58 kB | Unknown | Visualizza/Apri |
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
