Important Safety Information


Contraindication: KESIMPTA is contraindicated in patients with active hepatitis B virus infection.
Warnings and Precautions
Infections: An increased risk of infections has been observed with other anti-...

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Indication 
KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Powerful Efficacy

KESIMPTA provides the power of:

  • Up to nearly 60% reduction in relapses vs Aubagio1
  • Superior relative reductions in Gd+ T1 lesions and T2 lesions vs Aubagio1
  • Significant reductions in the risk of CDP vs Aubagio1

See clinical trial results below.

ASCLEPIOS I & II Study Design

Watch a brief overview of the pivotal trial results, hosted by a lead investigator.

Study Design

ASCLEPIOS I and II were 2 identical, double-blind, active comparator-controlled, parallel-group, multicenter, Phase 3 studies in patients with relapsing multiple sclerosis, approximately 40% of whom were DMT treatment naïve. Patients were randomized to double-dummy subcutaneous KESIMPTA® (ofatumumab) (20 mg every 4 weeks) or Aubagio (14 mg daily) for up to 30 months. Primary endpoint was ARR. Key MRI endpoints were number of Gd+ T1 lesions and annualized rate of new or enlarging T2 lesions. A key clinical endpoint was reduction in risk of 3-month CDP. Treatment duration was variable based on end of study criteria. Maximum duration 120 weeks, median duration 85 weeks.1

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KESIMPTA reduced key RMS disease activity measures, as evidenced by annualized relapse rate, MRI (Gd+ T1 and T2 lesions) and 3-month CDP

Annualized Relapse Rate

KESIMPTA demonstrated significant reduction in relapses of up to nearly 60% vs Aubagio

Primary endpoint: relative reduction in annualized relapses vs Aubagio1,2

ARR relative reduction ASCLEPIOS I & II
KESIMPTA reduced relapses to 0.1 per year, the equivalent of 1 every 10 patient years.*

*Based on ARR primary endpoint results.

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MRI Endpoints

KESIMPTA demonstrated near complete suppression of Gd+ T1 lesion activity

Profound reduction in active inflammatory Gd+ T1 lesions vs Aubagio for patients taking KESIMPTA (ofatumumab)

Mean number of Gd+ T1 lesions per scan1,2

Gd+T1 relative reduction ASCLEPIOS I & II
>94% Reduction in Gd+ T1 lesions vs Aubagio

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KESIMPTA demonstrated near complete suppression of T2 lesion activity

Superior reductions in T2 lesions vs Aubagio with KESIMPTA (ofatumumab)

Mean number of new or enlarging T2 lesions per year1,2

T2 relative reduction ASCLEPIOS I & II

*Negative binomial regression model.

>81% Reduction in T2 lesions vs Aubagio

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Confirmed Disability Progression vs Aubagio®

In a prespecified meta-analysis of pooled data from ASCLEPIOS I and II, KESIMPTA reduced the risk of CDP vs Aubagio1,2

34%reduced risk at 3 months (10.9% vs 15.0% with Aubagio, P=0.002)
32%reduced risk at 6 months (8.1% vs 12.0% with Aubagio, P=0.01)

Proportion of patients with 3-month CDP refers to Kaplan-Meier estimates at month 24.

Disability progression was defined as an increase in EDSS of at least 1.5, 1, or 0.65 points in patients with a baseline EDSS of 0, 1 to 5, or 5.5 or greater, respectively.

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Post Hoc: NEDA-3 (No Evidence of Disease Activity)

In ASCLEPIOS I and II1

  • Primary endpoint: ARR
  • Key MRI endpoints: number of Gd+ T1 lesions per scan, annualized rate of new or enlarging T2 lesions
  • Key clinical endpoint: 3-month CDP

NEDA-3* post hoc analysis3

NEDA-3 in 0-12M, NEDA-3 in 12-24M

No conclusions on clinical outcomes can be drawn. 

NEDA-3 Post Hoc Analysis Design3-5

NEDA Study Design

*Defined as no 6-month confirmed disability progression, no confirmed multiple sclerosis relapse, no new/enlarging T2 lesions, and no Gd+ T1 lesions.

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Start patients now

ARR=annualized relapse rate; CDP=confirmed disability progression; CI=confidence interval; DMT=disease-modifying therapy; EDSS=Expanded Disability Status Scale; Gd+=gadolinium-enhancing; MRI=magnetic resonance imaging; NEDA=no evidence of disease activity; RMS=relapsing multiple sclerosis.

References:

1. Kesimpta [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2020.
2. Hauser SL, Bar-Or A, Cohen JA, et al, for the ASCLEPIOS I and ASCLEPIOS II trial groups. Ofatumumab versus teriflunomide in multiple sclerosis. N Engl J Med. 2020;383(6):546-557.
3. Data on file. OMB157G (ofatumumab). Summary of clinical efficacy in relapsing multiple sclerosis. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019.
4. Data on file. OMB157G (ofatumumab) OMB157G 5.3.5.3. Statistical overview. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019.
5. Giovannoni G, Turner B, Gnanapavan S, Offiah C, Schmierer K, Marta M. Is it time to target no evident disease activity (NEDA) in multiple sclerosis? Mult Scler Relat Disord. 2015;4(4):329-333.

Indication

KESIMPTA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Important Safety Information

Contraindication: KESIMPTA is contraindicated in patients with active hepatitis B virus infection.

Warnings and Precautions

Infections: An increased risk of infections has been observed with other anti-CD20 B-cell depleting therapies. KESIMPTA has the potential for an increased risk of infections including serious bacterial, fungal, and new or reactivated viral infections; some have been fatal in patients treated with other anti-CD20 antibodies. The overall rate of infections and serious infections in KESIMPTA-treated patients was similar to teriflunomide-treated patients (51.6% vs 52.7%, and 2.5% vs 1.8%, respectively). The most common infections reported by KESIMPTA-treated patients in relapsing MS (RMS) trials included upper respiratory tract infection (39%) and urinary tract infection (10%). Delay KESIMPTA administration in patients with an active infection until resolved.

Consider the potential increased immunosuppressive effects when initiating KESIMPTA after an immunosuppressive therapy or initiating an immunosuppressive therapy after KESIMPTA.

Hepatitis B Virus: Reactivation: No reports of hepatitis B virus (HBV) reactivation in patients with MS treated with KESIMPTA. However, HBV reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with ofatumumab at higher intravenous doses for chronic lymphocytic leukemia (CLL) than the recommended dose in MS and in patients treated with other anti-CD20 antibodies.

Infection: KESIMPTA is contraindicated in patients with active hepatitis B disease. Fatal infections caused by HBV in patients who have not been previously infected have occurred in patients treated with ofatumumab at higher intravenous doses for CLL than the recommended dose in MS. Perform HBV screening in all patients before initiation of KESIMPTA. Patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], should consult liver disease experts before starting and during KESIMPTA treatment.

Progressive Multifocal Leukoencephalopathy: No cases of progressive multifocal leukoencephalopathy (PML) have been reported for KESIMPTA in RMS clinical studies; however, PML resulting in death has occurred in patients being treated with ofatumumab at higher intravenous doses for CLL than the recommended dose in MS. In addition, JC virus infection resulting in PML has also been observed in patients treated with other anti-CD20 antibodies and other MS therapies. If PML is suspected, withhold KESIMPTA and perform an appropriate diagnostic evaluation. If PML is confirmed, KESIMPTA should be discontinued.

Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to starting KESIMPTA for inactivated vaccines. The safety of immunization with live or live-attenuated vaccines following KESIMPTA therapy has not been studied. Vaccination with live or live-attenuated vaccines is not recommended during treatment and after discontinuation until B-cell repletion.

Vaccination of Infants Born to Mothers Treated with KESIMPTA During Pregnancy. For infants whose mother was treated with KESIMPTA during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines. If the B-cell count has not recovered in the infant, do not administer the vaccine as having depleted B-cells may pose an increased risk in these infants. 

Injection-Related Reactions: Injection-related reactions with systemic symptoms occurred most commonly within 24 hours of the first injection, but were also observed with later injections. There were no life-threatening injection reactions in RMS clinical studies. 

The first injection of KESIMPTA should be performed under the guidance of an appropriately trained health care professional. If injection-related reactions occur, symptomatic treatment is recommended. 

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections and after discontinuation of therapy until B-cell repletion. Consider discontinuing KESIMPTA therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.  

Fetal Risk: Based on animal data, KESIMPTA can cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to KESIMPTA in utero. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception while receiving KESIMPTA and for at least 6 months after the last dose.

Most common adverse reactions (>10%) are upper respiratory tract infection, headache, injection-related reactions, and local injection-site reactions. 

Please see full Prescribing Information, including Medication Guide.

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