Potential Skin & Joint Relief | COSENTYX® (secukinumab)

COSENTYX is a PsO treatment proven effective for adults with active PsA

In pivotal study FUTURE 2 in adults with active PsA

A majority of patients achieved ACR20 response at Week 24 (NRI)^1*

(P<0.0001 for both Rx groups vs placebo)*

COSENTYX 300 mg (n=100): 54%
COSENTYX 150 mg (n=100): 51%
Placebo (n=98): 15%

*Except where noted, patients received an initial once-weekly x5 weeks loading dose followed by doses every 4 weeks.¹

^†TRx share for PsA/AS/nr-axSpA written by rheumatology specialty groups, including rheumatologists, rheumatology NPs/PAs, and PCPs. Additional data adjustment factors are applied using Symphony Xponent and APLD data. TRx is total prescriptions (NBRx + refills). Data report prescriptions for patients receiving an anti–IL-17 or anti–IL-23 for PsA/AS/nr-axSpA from January 1, 2020, to June 1, 2021.³

Structural joint damage can be irreversible⁴

In the FUTURE 5 trial in adults with active PsA

COSENTYX was proven to inhibit the progression of joint structural damage⁵

Clinical Trail Results for Joint Structural Damage

^aResults from a linear mixed effects model that excluded data after escape for placebo subjects who received escape therapy at Week 16. The model assumes approximately linear progression over time and estimates a difference in rates (slopes) of progression over 24 weeks to compare treatment arms.⁵
^bRepresents COSENTYX 150 mg with loading dose (LD).
^cNo disease progression is defined as change from baseline in mTSS of less than or equal to 0.⁵
mTSS measures radiographic progression in the hands and feet and is expressed as the sum of two components: erosion scores and joint space narrowing.⁵
In FUTURE 5, separate radiographs of each hand/wrist and each foot were taken at baseline, Week 16, and Week 24. Bone erosion, joint space narrowing, and total radiographic scores were determined using a PsA-modified van der Heijde-Sharp scoring method that included the second through fifth distal interphalangeal joints of each hand.^4,5

In FUTURE 5, in a mixed population of about 2/3 biologic-naive and 1/3 anti-TNF-α inadequate responders⁶

Majority of patients had improvement in their ability to function at 1 year⁴

The HAQ-DI score is an assessment of patients' ability to⁶:

The HAQ-DI Score Assesses Patient Abilities

Patients achieving a meaningful^‡ HAQ-DI response at 1 year (a prespecified exploratory analysis) using nonresponder imputation^6,7§

60% of patients in the 300 mg group (n=220)⁴
58% of patients in the 150 mg group (n=219)⁴
At Week 16, 62% and 55% of patients in the COSENTYX 300 mg and 150 mg arms, respectively, had a meaningful HAQ-DI response^6‡
At baseline, mean HAQ-DI scores were 1.2, 1.3, and 1.3 for the groups receiving COSENTYX 300 mg, COSENTYX 150 mg, and placebo, respectively. Mean change at Week 16: -0.55, -0.44, and -0.21, respectively⁶

In FUTURE 5, ACR20 response rates at Week 16 (primary end point) were 63% for COSENTYX 300 mg (P<0.0001), 56% for COSENTYX 150 mg (P<0.0001), and 27% for placebo.^6§

^‡Defined as a change from baseline HAQ-DI score of ≥0.3.⁷
^§All patients who met escape criteria (less than 20% improvement in tender or swollen joint counts) at Week 16 were considered nonresponders at Week 20 and Week 24. Results were analyzed using nonresponder imputation.⁶

Please see FUTURE 2 (pivotal trial) and FUTURE 5 Extension study design details

STUDY DESIGNS

FUTURE 2^1-5
FUTURE 2 was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that is evaluating 397 adult patients with active PsA (≥3 swollen joints and ≥3 tender joints) despite use of NSAlDs, corticosteroids, or DMARDs. Patients had a diagnosis for ≥5 years and were randomized in a 1:1:1 ratio to receive COSENTYX.

150 mg (n=100), 300 mg (n=100), or placebo (n=98) subcutaneously at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks. Patients who received placebo were rerandomized (1:1) to COSENTYX 150 mg or 300 mg every 4 weeks, at Week 16 or Week 24, based on responder status. The primary end point was the percentage of patients with ACR20 response at Week 24.²

After Week 24, patients knew they were taking the active treatment but remained blind to the dose until after 1 year. After 1 year, patients were unblinded and continued to receive the same active dose as open-label treatment and were assessed every 8 weeks through 2 years and every 12 weeks from 2 years to 4 years.² Starting at Week 128, patients whose signs and symptoms were not fully controlled and might improve further with an increase in dose as judged by the investigator, were updosed from 150 mg dose to 300 mg dose. At Week 208, 45 patients from the 150 mg dose arm had been updosed to 300 mg.^3,4 A 75 mg arm was included in this study, but not shown and is not an approved dose.¹ Study population was mixed: two-thirds of patients were anti-TNFα-naive and one-third were anti-TNFα-experienced (patients could have been exposed to up to 3 different TNFα inhibitors).² At baseline, 44% of patients treated with COSENTYX were treated with concomitant MTX.²

FUTURE 5^1,6-8
FUTURE 5 was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that is evaluating 996 adult patients with active PsA. Patients were randomized in 2:2:2:3 ratio to receive COSENTYX 150 mg without load (n=222), 150 mg with load (n=220), 300 mg with load (n=222), or placebo (n=332) subcutaneously at Weeks 0, 1, 2, and 3, followed by the same dose every 4 weeks. Patients who received placebo were rerandomized (1:1) to receive COSENTYX (either 150 mg or 300 mg every 4 weeks) based on responder status at Week 16 (nonresponders) or Week 24 (responders).⁶

The primary end point was the percentage of patients who achieved ACR20 response at Week 16.⁶ After Week 24, patients knew they were taking the active treatment but remained blind to the dose until after 1 year. Secondary end points included change in mTSS score at Week 24 from baseline, ACR50 response, proportion of patients with dactylitis and enthesitis, and overall safety and tolerability.⁶

Study population was mixed: more than two-thirds of patients were anti-TNF-α-naive and less than one-third were anti-TNF-α-experienced (patients could have been exposed to up to 3 different TNF-α inhibitors).⁶

ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; mTSS, modified Total Sharp Score; MTX, methotrexate; NSAIDs, nonsteroidal anti-inflammatory drugs; PsA, psoriatic arthritis; TNF, tumor necrosis factor.

References
1. Cosentyx. Prescribing Information. Novartis Pharmaceuticals Corp.
2. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.
3. Data on file. CAIN457F2312 (FUTURE 2): 3-Year Interim Study Report. Novartis Pharmaceuticals Corp; September 2017.
4. Data on file. CAIN457F2312 (FUTURE 2): 4-Year Interim Report. Novartis Pharmaceuticals Corp; 2018.
5. McInnes IB et al; for the FUTURE 2 Study Group. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;386:1137-1146. doi:10.1016/S0140-6736(15)61134-5
6. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis at Week 24. Novartis Pharmaceuticals Corp; November 2017.
7. Mease P et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018;77(6):890-897. doi:10.1007/s40265-014-0191-y
8. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis - Week 52. Novartis Pharmaceuticals Corp; 2018.

Tap to see IMPORTANT SAFETY INFORMATION and INDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
COSENTYX^® (secukinumab) is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis and angioedema have been reported during treatment with COSENTYX...

CONTRAINDICATIONS

COSENTYX^® (secukinumab) is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis and angioedema have been reported during treatment with COSENTYX.

WARNINGS AND PRECAUTIONS

Infections

COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in COSENTYX treated subjects compared to placebo-treated subjects. In placebo-controlled clinical trials in subjects with moderate to severe PsO, higher rates of common infections, such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%) and mucocutaneous infections with candida (1.2% versus 0.3%) were observed in subjects treated with COSENTYX compared to placebo-treated subjects. A similar increase in risk of infection in subjects treated with COSENTYX was seen in placebo-controlled trials in subjects with PsA, AS and nr-axSpA. The incidence of some types of infections, including fungal infections, appeared to be dose-dependent in clinical trials.

In the postmarketing setting, serious bacterial, viral, and fungal opportunistic infections, and some fatal infections have been reported in patients receiving IL-17 inhibitors including COSENTYX. Cases of Hepatitis B virus reactivation have been reported.

Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, monitor the patient closely and discontinue COSENTYX until the infection resolves.

If signs of Hepatitis B virus reactivation occur, consult a hepatitis specialist. COSENTYX is not recommended for use in patients with active viral hepatitis.

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Avoid administration of COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients closely for signs and symptoms of active TB during and after treatment.

Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD) exacerbations, in some cases serious and/or leading to discontinuation of COSENTYX, occurred in COSENTYX treated subjects during clinical trials in PsO, PsA, AS, nr-axSpA, and HS. In adult subjects with HS, the incidence of IBD was higher in subjects who received COSENTYX 300 mg every 2 weeks (Ulcerative Colitis [UC] 1 case, EAIR 0.2/100 subject-years; Crohn’s Disease [CD] 1 case, EAIR 0.2/100 subject-years) compared to subjects who received COSENTYX 300 mg every 4 weeks (IBD 1 case, EAIR 0.2/100 subject-years). In addition, new onset IBD cases occurred in subjects treated with COSENTYX in clinical trials. In an exploratory trial in 59 subjects with active Crohn’s disease [COSENTYX is not approved for the treatment of Crohn’s disease], there were trends toward greater disease activity and increased adverse reactions in subjects treated with COSENTYX as compared to placebo-treated subjects.

Exercise caution when prescribing COSENTYX to patients with IBD. Patients treated with COSENTYX should be monitored for signs and symptoms of IBD.

Eczematous Eruptions

In postmarketing reports, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma, were reported in patients receiving COSENTYX; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of COSENTYX.

Treatment may need to be discontinued to resolve the eczematous eruption. Some patients were successfully treated for eczematous eruptions while continuing COSENTYX.

Hypersensitivity Reactions

Serious hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in COSENTYX treated subjects in clinical trials and in the post-marketing setting. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of COSENTYX and initiate appropriate therapy.

The removable caps of the COSENTYX Sensoready^® pen and the COSENTYX 1 mL and 0.5 mL prefilled syringes contain natural rubber latex, which may cause an allergic reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.

Immunizations

Prior to initiating therapy with COSENTYX, consider completion of all age-appropriate immunizations according to current immunization guidelines. COSENTYX may alter a patient’s immune response to live vaccines. Avoid use of live vaccines in patients treated with COSENTYX.

MOST COMMON ADVERSE REACTIONS

Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.

Please see Full Prescribing Information, including Medication Guide.

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COSENTYX is a PsO treatment proven effective for adults with active PsA

In pivotal study FUTURE 2 in adults with active PsA

A majority of patients achieved ACR20 response at Week 24 (NRI)1*

Structural joint damage can be irreversible4

In the FUTURE 5 trial in adults with active PsA

COSENTYX was proven to inhibit the progression of joint structural damage5

In FUTURE 5, in a mixed population of about 2/3 biologic-naive and 1/3 anti-TNF-α inadequate responders6

Majority of patients had improvement in their ability to function at 1 year4

Patients achieving a meaningful‡ HAQ-DI response at 1 year (a prespecified exploratory analysis) using nonresponder imputation6,7§