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JOIN US AT THE ASH ANNUAL MEETING FOR A PRESENTATION ON ENJAYMO  |  MONDAY 12/12 @ 8 am

Not an official event of the 64th ASH Annual Meeting and Exposition. This presentation is not sponsored or endorsed by ASH. Not CME-accredited. MAT-US-2208046-v1.0-11/2022

VISIT US AT ASH  |  DECEMBER 10-13  |  BOOTH #643

Not an official event of the 64th ASH Annual Meeting and Exposition. This presentation is not sponsored or endorsed by ASH. Not CME-accredited. MAT-US-2208046-v1.0-11/2022

With unpredictable risk and profound fatigue, Cold Agglutinin Disease (CAD) is a severe disease with high unmet need1-5

For patients with CAD, the effects of chronic hemolysis can cause acute consequences and chronic risks

CAD is a rare, complement-mediated, autoimmune hemolytic anemia with acute consequences and chronic risks.1-3 Hemolysis in CAD is driven by C1 activation of the classical complement pathway, when cold agglutinins (IgM autoantibodies) recruit and activate C1, typically at body temperatures under 98.6 °F (37 °C).6,7 Get a deeper look at the mechanism of hemolysis in CAD and how ENJAYMO works.

“CAD is an insidious disease. I looked perfectly normal, but it was silent, sapping my strength…my energy level just dropped.”

—Nancy, living with CAD

Unmet needs remain for patients despite management with cold avoidance and therapies not indicated for CAD

blood drop
COLD AVOIDANCE MAY NOT EFFECTIVELY MANAGE CAD8
75% of patients needed drug therapy, with a median of 7 therapies needed during follow-up (median duration 42.8 months)*
Data from a retrospective analysis of 610 patients with CAD.
hemolysis
SEVERE ANEMIA PERSISTS DESPITE CURRENT MANAGEMENT2
67% had a severe anemia event within the first 6 months of drug therapy (12/18)†
Data from a retrospective analysis of 29 patients with CAD.
fatigued person
FATIGUE PROFOUNDLY IMPACTS DAILY LIVING5
90% reported fatigue having the greatest impact on quality of life (45/50). Of these patients who devised coping mechanisms for fatigue, only 28% were satisfied (12/44)‡
Data from a prospective, self-reported survey of 50 patients with CAD.
CAD can be a serious hardship for patients, with more than half declaring their disease as severe or moderate (27/50)5‡

Patients with CAD endure an invisible burden of profound fatigue5

In a US patient survey, fatigue is the CAD-related symptom patients self-reported as having the greatest impact on their daily lives (45/50)‡

Impact of fatigue on daily life from a prospective survey of patients with CAD (N=50)

  • *Therapies included corticosteroids, danazol, ibrutinib, immunoglobulin, rituximab, immunosuppressants, antineoplastics, plasma exchange, splenectomy, and other biologics (eg, eculizumab and lymphocyte immune globulin antithymocyte globulin).
  • †Study patients with CAD were initiated on therapies including corticosteroids, IV immunoglobulin, rituximab, immunosuppressants, antineoplastics (eg, bendamustine), or biologics (eg, eculizumab).
  • ‡Data from a self-administered internet-based survey are likely to be biased toward patients with access to the internet and a computer (ie, a bias to younger and socioeconomically advantaged patients). A recall bias and reporting from memory may result in an underestimation of certain clinical information.

FACIT-Fatigue is a patient-reported outcome instrument with scores ranging from 0 to 52, with higher scores indicating less fatigue.

Chronic complement-mediated hemolysis in CAD drives year-round anemia, regardless of season15

In a retrospective analysis of patients with CAD (n=594)

Mean values of hemoglobin and bilirubin levels by season

Hb levels by season graph
Mean Hb remained
below the lower limit of normal
through all 4 seasons
bilirubin levels by season graph
Mean bilirubin remained
above the upper limit of normal
through all 4 seasons

The estimated median value for LDH was above normal for all 4 seasons‖

  • §Normal hemoglobin levels for adults vary, but in general are 14 to 17 g/dL for males and 12 to 16 g/dL for females. Normal bilirubin is 0.3 to 1.2 mg/dL.
  • ‖Adjusted median LDH concentrations ranged from 309.10 to 367.10 U/L across the four seasons and indicated persistent year-round hemolysis for the group, on average (assuming an upper limit of normal of 280 U/L for LDH)
Resulting anemia and fatigue from complement-mediated hemolysis may be impacting patients with CAD more than you realize
woman riding a bicycle
woman riding a bicycle
Patient portrayal.

ENJAYMO HCP Indication and Important Safety Information

INDICATION

ENJAYMO® (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients.

WARNINGS AND PRECAUTIONS

Serious Infections Including Those Caused by Encapsulated Bacteria

  • ENJAYMO, a proximal classical complement C1s inhibitor, increases susceptibility to serious infections, including those caused by encapsulated bacteria e.g. Neisseria meningitidis (any serogroup, including non-groupable strains), Streptococcus pneumoniae, and Haemophilus influenzae type B.
  • Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors.
  • Serious infections (bacterial and viral) were reported in 15% (10/66) of patients receiving ENJAYMO in the two phase 3 trials. These infections included urinary tract infection with sepsis, respiratory tract infection, pneumonia, otomastoiditis, and skin infections. One patient (1.5%) died due to Klebsiella pneumoniae.
  • Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of ENJAYMO, according to the most current ACIP recommendations for patients receiving a complement inhibitor.
  • If urgent ENJAYMO therapy is indicated in a patient who is not up to date on their vaccine(s), administer as soon as possible.
  • Vaccination does not eliminate the risk of serious encapsulated bacterial infections. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected.
  • If ENJAYMO treatment is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection. Some infections may become rapidly life-threatening or fatal if not recognized and treated promptly. Inform patients of these signs and symptoms and steps to be taken to seek immediate medical care.
    • Consider interruption of ENJAYMO treatment in patients who are undergoing treatment for serious infection.
    • Consider patients’ immune status when initiating treatment with ENJAYMO.

Infusion-Related Reactions

  • Administration of ENJAYMO may result in infusion-related reactions. In the two phase 3 trials, 29% (19/66) of patients treated with ENJAYMO experienced infusion-related reactions. One patient permanently discontinued ENJAYMO due to an infusion-related reaction.
  • Monitor patients for infusion-related reactions and interrupt if a reaction occurs.
  • Discontinue ENJAYMO infusion and institute appropriate supportive measures if signs of hypersensitivity reactions, such as cardiovascular instability or respiratory compromise, occur.

Risk of Autoimmune Disease

  • Based on its mechanism of action, ENJAYMO may potentially increase the risk for developing autoimmune diseases such as systemic lupus erythematosus (SLE). Development of SLE has been associated with inherited classical complement deficiency.
  • In clinical trials, 4.5% (3/66) of patients developed a relapse or worsening of previously diagnosed autoimmune disease.
  • Monitor ENJAYMO patients for signs and symptoms and manage medically.

Recurrent Hemolysis After ENJAYMO Discontinuation

  • If treatment with ENJAYMO is interrupted, closely monitor patients for signs and symptoms of recurrent hemolysis, eg, elevated levels of total bilirubin or lactate dehydrogenase (LDH) accompanied by a decrease in hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria. Consider restarting ENJAYMO if signs and symptoms of hemolysis occur after discontinuation.

ADVERSE REACTIONS

  • The most common adverse reactions in the CADENZA trial (Part A) (incidence ≥18%) are rhinitis, headache, hypertension, acrocyanosis, and Raynaud’s phenomenon. The most common adverse reactions in the CARDINAL trial (incidence ≥25%) are urinary tract infection, respiratory tract infection, bacterial infection, dizziness, fatigue, peripheral edema, arthralgia, cough, hypertension, and nausea.

Please see full Prescribing Information.

See the full Medication Guide.

CAD=Cold Agglutinin Disease; CLL=chronic lymphocytic leukemia; FACIT=Functional Assessment of Chronic Illness Therapy; IgM=immunoglobulin M; LDH=lactate dehydrogenase; LLN=lower limit of normal; PNH=paroxysmal nocturnal hemoglobinuria; SLE=systemic lupus erythematosus; ULN=upper limit of normal.
References:
  1. Berentsen S. Beiske K, Tjønnfjord GE. Primary chronic cold agglutinin disease: an update on pathogenesis, clinical features and therapy. Hematology. 2007;12(5):361-370. doi: 10.1080/10245330701045392
  2. Mullins M, Jiang X, Bylsma LC, et al. Cold agglutinin disease burden: a longitudinal analysis of anemia, medications, transfusions, and health care utilization. Blood Adv. 2017;1(13):839-848. doi:10.1182/bloodadvances.2017004390
  3. Broome CM, Cunningham JM, Mullins M, et al. Increased risk of thrombotic events in cold agglutinin disease: a 10-year retrospective analysis. Res Pract Thromb Haemost. 2020;4(4):628-635. doi:10.1002/rth2.12333
  4. Swiecicki PL, Hegerova LT, Gertz MA. Cold agglutinin disease. Blood. 2013;122(7):1114-1121. doi:10.1182/blood-2013-02-474437
  5. Joly F, Schmitt LA, McGee Watson PA, Pain E, Testa D. The burden of cold agglutinin disease on patients’ daily life: web-based cross-sectional survey of 50 American patients. JMIR Form Res. 2022:6(7):e34248. doi: 10.2196/34248
  6. Noris M, Remuzzi G. Overview of complement activation and regulation. Semin Nephrol. 2013;33(6):479-492. doi:10.1016/j.semnephrol.2013.08.001
  7. Berentsen S. Complement activation and inhibition in autoimmune hemolytic anemia: focus on cold agglutinin disease. Semin Hematol. 2018;55(3):141-149. doi:10.1053/j.seminhematol.2018.04.002
  8. Pham HP, Wilson A, Adeyemi A, et al. An observational analysis of disease burden in patients with cold agglutinin disease: Results from a large US electronic health record database. J Manag Care Spec Pharm. 2022;28(12):1419-1428. doi:10.18553/jmcp.2022.28.12.1419
  9. Cella D, Lai J-S, Chang C-H, Peterman A, Slavin M. Fatigue in cancer patients compared with fatigue in the general United States population. Cancer. 2002;94(2):528-538. doi:10.1002/cncr.10245
  10. Röth A, Berentsen S, Barcellini W, et al. Sutimlimab in patients with cold agglutinin disease, results of the randomized placebo-controlled phase 3 CADENZA trial. Blood. 2022;140(9):980-991. doi:org/10.1182/blood.2021014955
  11. Cella D, Johansson P, Ueda Y, et al. Clinically important difference for the FACIT-Fatigue scale in paroxysmal nocturnaI hemoglobinuria: a derivation from internationaI PNH registry patient data. Blood. 2021;138(Suppl 1I):1952-1954.
  12. Cella D, Yount S, Sorensen M, Chartash E, Sengupta N, Grober J. Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis. J Rheumatol. 2005:32(5):811-819.
  13. Eek D, lvanescu C, Corredoira L, Meyers O, Cella D. Content validity and psychometric evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue scale in patients with chronic lymphocytic leukemia. J Patient Rep Outcomes. 2021;5(1):27-37. doi:10.1186/s41687-021-00294-1
  14. Goligher EC, Pouchot J, Brant R, et al. Minimal clinically important difference for 7 measures of fatigue in patients with systemic lupus erythematosus. J Rheumatol. 2008;35(4):635-642.
  15. Röth A, Fryzek J, Jiang X, et al. Complement-mediated hemolysis persists year round in patients with cold agglutinin disease. Transfusion. 2022;62(1):51-59. doi:10.1111/trf.16745
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ENJAYMO HCP Indication and Important Safety Information

INDICATION

ENJAYMO® (sutimlimab-jome) is indicated for the treatment of hemolysis in adults with cold agglutinin disease (CAD).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ENJAYMO is contraindicated in patients with known hypersensitivity to sutimlimab-jome or any of the inactive ingredients.

WARNINGS AND PRECAUTIONS

Serious Infections Including Those Caused by Encapsulated Bacteria

  • ENJAYMO, a proximal classical complement C1s inhibitor, increases susceptibility to serious infections, including those caused by encapsulated bacteria e.g. Neisseria meningitidis (any serogroup, including non-groupable strains), Streptococcus pneumoniae, and Haemophilus influenzae type B.
  • Life-threatening and fatal infections with encapsulated bacteria have occurred in both vaccinated and unvaccinated patients treated with complement inhibitors.
  • Serious infections (bacterial and viral) were reported in 15% (10/66) of patients receiving ENJAYMO in the two phase 3 trials. These infections included urinary tract infection with sepsis, respiratory tract infection, pneumonia, otomastoiditis, and skin infections. One patient (1.5%) died due to Klebsiella pneumoniae.
  • Complete or update vaccination against encapsulated bacteria at least 2 weeks prior to administration of the first dose of ENJAYMO, according to the most current ACIP recommendations for patients receiving a complement inhibitor.
  • If urgent ENJAYMO therapy is indicated in a patient who is not up to date on their vaccine(s), administer as soon as possible.
  • Vaccination does not eliminate the risk of serious encapsulated bacterial infections. Closely monitor patients for early signs and symptoms of serious infection and evaluate patients immediately if an infection is suspected.
  • If ENJAYMO treatment is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection. Some infections may become rapidly life-threatening or fatal if not recognized and treated promptly. Inform patients of these signs and symptoms and steps to be taken to seek immediate medical care.
    • Consider interruption of ENJAYMO treatment in patients who are undergoing treatment for serious infection.
    • Consider patients’ immune status when initiating treatment with ENJAYMO.

Infusion-Related Reactions

  • Administration of ENJAYMO may result in infusion-related reactions. In the two phase 3 trials, 29% (19/66) of patients treated with ENJAYMO experienced infusion-related reactions. One patient permanently discontinued ENJAYMO due to an infusion-related reaction.
  • Monitor patients for infusion-related reactions and interrupt if a reaction occurs.
  • Discontinue ENJAYMO infusion and institute appropriate supportive measures if signs of hypersensitivity reactions, such as cardiovascular instability or respiratory compromise, occur.

Risk of Autoimmune Disease

  • Based on its mechanism of action, ENJAYMO may potentially increase the risk for developing autoimmune diseases such as systemic lupus erythematosus (SLE). Development of SLE has been associated with inherited classical complement deficiency.
  • In clinical trials, 4.5% (3/66) of patients developed a relapse or worsening of previously diagnosed autoimmune disease.
  • Monitor ENJAYMO patients for signs and symptoms and manage medically.

Recurrent Hemolysis After ENJAYMO Discontinuation

  • If treatment with ENJAYMO is interrupted, closely monitor patients for signs and symptoms of recurrent hemolysis, eg, elevated levels of total bilirubin or lactate dehydrogenase (LDH) accompanied by a decrease in hemoglobin, or reappearance of symptoms such as fatigue, dyspnea, palpitations, or hemoglobinuria. Consider restarting ENJAYMO if signs and symptoms of hemolysis occur after discontinuation.

ADVERSE REACTIONS

  • The most common adverse reactions in the CADENZA trial (Part A) (incidence ≥18%) are rhinitis, headache, hypertension, acrocyanosis, and Raynaud’s phenomenon. The most common adverse reactions in the CARDINAL trial (incidence ≥25%) are urinary tract infection, respiratory tract infection, bacterial infection, dizziness, fatigue, peripheral edema, arthralgia, cough, hypertension, and nausea.

Please see full Prescribing Information.

See the full Medication Guide.