Cosentyx is indicated for the treatment of: active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy; active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs.1
Full indications for Cosentyx can be found here
ALL-IN-ONE relief for eligible adult patients with axSpA1–3
Cosentyx has demonstrated efficacy in the key clinical hallmarks of axSpA: morning stiffness, spinal pain, fatigue and nocturnal back pain.1–3
Mean percentage change from baseline in biologic-naïve patients with AS (as observed data with 150 mg s.c. load):
Spinal pain4
Mean baseline score:
Cosentyx 150 mg group
(n=44) 67.0;
placebo group (n=45) 67.6
Assessment:
Spinal pain (VAS) ≥4 cm (0–100 mm) at baseline.7
Fatigue4
Mean baseline score:
Cosentyx 150 mg group
(n=44) 22.3;
placebo group (n=45) 23.3
Assessment:
FACIT-F: 13-item questionnaire assesses self-reported fatigue and its impact on daily activities and function. Total possible range of fatigue scale is 0 to 52, with higher scores representing lower fatigue levels.7
Nocturnal back pain5,6
Mean baseline score:
Cosentyx 150 mg group
(n=44) 66.8;
placebo group (n=45) 63.9
Assessment:
Nocturnal back pain is defined as back pain that occurs at night. Exacerbation of nocturnal back pain may force the patient to rise and walk around, particularly during the second half of the night.8
Morning stiffness4
Mean baseline score:
Cosentyx 150 mg group
(n=44) 6.8;
placebo group (n=45) 6.6
Assessment:
Morning stiffness defined as severity and duration, calculated as the mean of questions 5 and 6 of the BASDAI.9
Similar results seen in nr-axSpA10
Guidelines, based on clinical and real-world experience, continue to support use of an IL-17 inhibitor, such as Cosentyx, in axSpA (AS and nr-axSpA)11,12
Download a summary of the key Cosentyx efficacy data here
FAST (16 weeks) and LASTING (≥52 weeks): see the effects of Cosentyx on the key clinical hallmarks of axSpA, as measured by:
Ankylosing spondylitis (AS)
Cosentyx demonstrated reductions in mean ASAS20/40 score in TNFi-naïve patients with AS through Year 5*2,13–17
(data presented are NRI up to Week 16 and as observed from Week 20)
Adapted from Rheumatology DOF UK.
The primary endpoint of the MEASURE 2 trial, ASAS20 at Week 16 for Cosentyx vs placebo, was met (p<0.001 in TNFi-naïve; p<0.05 in TNFi-inadequate responder).13,17
*p=0.0007 vs placebo
†p=0.0167 vs placebo
Non-radiographic axial spondyloarthritis (nr-axSpA)
Cosentyx demonstrated reductions in mean ASAS20/40 score in TNFi-naïve patients with nr-axSpA through Year 2†1,3,10
(data presented are as observed)
Adapted from Novartis data on file. CAIN457H2315.
The primary endpoint of the PREVENT trial (the proportion of patients with ASAS40 at Week 16) was met (p<0.05).3
Ankylosing spondylitis (AS)
Cosentyx demonstrated reductions in mean BASDAI score in TNFi-naïve patients with AS through Year 5‡4,17,18
(data presented are MMRM up to Week 16 and as observed from Week 20)
Adapted from Novartis data on file. CAIN457F2310.
The primary endpoint of the MEASURE 2 trial, ASAS20 at Week 16 for Cosentyx vs placebo, was met (p<0.001 in TNFi-naïve; p<0.05 in TNFi-inadequate responder).13,17
Non-radiographic axial spondyloarthritis (nr-axSpA)
Cosentyx demonstrated reductions in mean BASDAI score in TNFi-naïve patients with nr-axSpA through Year 2§3,19
(data presented are MMRM up to Week 16 and as observed from Week 20)
Adapted from Novartis data on file. CAIN457F2310.
The primary endpoint of the PREVENT trial (the proportion of TNFi-naïve patients with ASAS40 at Week 16) was met.3
Ankylosing spondylitis (AS)
Cosentyx demonstrated FAST and LASTING relief from fatigue through Year 2¶17,20
Proportion of patients with FACIT-F response over 2 years (data are as observed; exploratory endpoint)
Adapted from Kvien TK, et al. 2017.
The primary endpoint of the MEASURE 1 and 2 trials (ASAS20 at Week 16 for Cosentyx vs placebo for the overall patient population) was met.17
Most patients who start on Cosentyx, stay on Cosentyx
Real-world data from the UK show the majority of patients with AS who started on Cosentyx (N=108) remained on treatment for at least 2 years.21
Year 1
stayed with Cosentyx
(95% CI: 83–96)
Year 2
stayed with Cosentyx
(95% CI: 67–85)
Full indications
Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults, children and adolescents from the age of 6 years who are candidates for systemic therapy; active psoriatic arthritis (PsA) in adult patients (alone or in combination with methotrexate [MTX]) when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate; active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy; active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs; active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy; active enthesitis-related arthritis (ERA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy; active juvenile psoriatic arthritis (JPsA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.1
*MEASURE 2 included patients who did not switch treatment and who switched to open-label or standard of care after Week 20.
†Patients on Cosentyx 150 mg received a 150 mg loading dose.
‡MEASURE 2 BASDAI data presented are an exploratory endpoint; no statistical analysis performed. Patients on Cosentyx 150 mg received a 150 mg loading dose.
§PREVENT BASDAI data presented were an exploratory endpoint; no statistical analysis performed. Includes patients who did not switch treatment and who switched to open-label or standard of care after Week 20. The proportion of patients who switched to either open-label Cosentyx or standard of care between Weeks 20 and 52, based on clinical judgement of disease activity by the investigator and the patient, was 50.8% (94/185, with 94 switching to open-label and 2 subsequently switching to standard of care treatment with anti-TNF) in 150 mg loading dose.
¶MEASURE 1/2 FACIT-F data are an exploratory endpoint. FACIT-F response was defined as improvement (increase in FACIT-F score) by ≥4.0 points from baseline. Data from the MEASURE 1 study are from patients who entered the MEASURE 1 long-term extension study at Week 104.
AS, ankylosing spondylitis; ASAS, Assessment of Spondyloarthritis international Society; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; CI, confidence interval; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HS, hidradenitis suppurativa; JIA, juvenile idiopathic arthritis; MMRM, mixed model repeated measures; MTX, methotrexate; nr-axSpA, non-radiographic axial spondyloarthritis; s.c., subcutaneous; SmPC, Summary of Product Characteristics; TNF, tumour necrosis factor; TNFi, tumour necrosis factor inhibitor; TNFi-IR, tumour necrosis factor inhibitor-inadequate responder; VAS, visual analogue scale.
References
- Cosentyx (secukinumab) Summary of Product Characteristics.
- Marzo-Ortega H, et al. Lancet Rheumatol 2020 (6);2:e339–e346.
- Deodhar A, et al. Arthritis Rheumatol 2021;73(1):110–120.
- Novartis data on file. CAIN457F2310 Data Analysis Report. June 2019.
- Novartis data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. January 2020.
- Novartis data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain February 2021.
- Deodhar A, et al. Clin Exp Rheumatol 2019;37(2):260–269.
- Taurog JD, et al. N Engl J Med 2016;375(13):1303.
- Marzo-Ortega H, et al. Arthritis Care Res 2017;69(7):1020–1029 and supplementary tables.
- Novartis data on file. CAIN457H2315 Data Analysis Report. August 2021.
- Ramiro S, et al. Ann Rheum Dis 2023;82(1):19–34.
- Hamilton L, et al. Rheumatol 2017;56(2):313–316.
- Rheumatology DOF UK 22.
- Rheumatology DOF UK 23.
- Rheumatology DOF UK 268.
- Rheumatology DOF UK 269.
- Baeten D, et al. N Engl J Med 2015;373(26):2534–2548.
- Zochling J. Arthritis Care Res (Hoboken) 2011;63(suppl 11):S47–S58.
- Novartis data on file. CAIN457H2315 Data Analysis Report. April 2020.
- Kvien TK, et al. Ann Rheum Dis 2017;76(suppl. 2):355–356. Abstract THU0393.
- Gaffney K, et al. Rheum Adv Prac 2023;7(2):rkad055.