CLINICAL TRIAL RESULTS

Choose POWERFUL efficacy: choose KESIMPTA^® (ofatumumab)

Significant relapse reductions (primary
end point)^1,2

Post hoc analysis: early and continued relapse reduction over the studied period³

Near complete
suppression of MRI Gd+
T1 & T2 lesion activity^1,2

Reduced risk of CDP
at 3 and 6 months^1,2

The POWER of superior reduction in relapses vs Aubagio

Review ASCLEPIOS I and II Study Design

Superior relapse reductions of up to nearly 60% vs Aubagio

Primary end point: relative reduction in annualized relapses

vs Aubagio^® (teriflunomide)^1,2

Primary end point: relative

reduction in annualized relapses

vs Aubagio^® (teriflunomide)^1,2

0.1 RELAPSE PER YEAR IS THE EQUIVALENT OF
1 RELAPSE EVERY 10 PATIENT-YEARS*

*Based on ARR primary end point results.

Your patients expect fewer relapses. Start KESIMPTA in recently relapsed RMS patients.

Early and continued relapse reduction over the study period^3,4*

Post hoc analysis of pooled data from ASCLEPIOS I and II

Cumulative ARR by time interval

N'=total number of patients included in the analysis.

No conclusions can be drawn.

Post hoc study design: ARR by time intervals was analyzed from the pooled pivotal trials. The ARR (95% CI) was estimated separately for each time interval by fitting a negative binomial regression model adjusted for treatment as factor.

*Reduction in ARR seen in the first 3 months and time intervals over 2 years.

Your RMS patients expect a treatment that reduces relapses early on. Offer KESIMPTA to recently diagnosed patients.

The POWER to help reduce MRI lesion activity

Near complete suppression of Gd+ T1 and T2 lesion activity

Profound reduction in active inflammatory Gd+ T1 lesions vs Aubagio

Mean number of Gd+ T1 lesions per MRI scan^1,2

Mean number of Gd+ T1 lesions

per MRI scan^1,2

Superior reductions in T2 lesions
vs Aubagio

Mean number of new or enlarging T2 lesions per year^1,2

Mean number of new or

enlarging T2 lesions per year^1,2

*Negative binomial regression model.

MRI lesion activity is a hallmark of worsening RMS. Initiate KESIMPTA in RMS patients at the first sign of MRI lesion activity.

The POWER to fight the risk of disability progression

Significantly reduced 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 Aubagio.^1,2

34%

REDUCED RISK AT 3 MONTHS

(10.9% vs 15.0% with Aubagio, P=0.003)

32%

REDUCED RISK AT 6 MONTHS⁶

(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.

Delay tomorrow's progression:
take the first step today with KESIMPTA.

I missed my son's soccer game because of a relapse.
There may be a different treatment that's right for me.

Kristin: mom, real estate agent, KESIMPTA patient*

For adults only.

*Actual KESIMPTA patient who was compensated for their time. Individual results may vary.

Dig deeper into the data on KESIMPTA efficacy for patients with RMS.

Review the pivotal and post hoc analysis

Start patients on KESIMPTA today

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ARR=annualized relapse rate; CDP=confirmed disability progression; CI=confidence interval; EDSS=Expanded Disability Status Scale; Gd+=gadolinium-enhancing; MOA=mechanism of action; MRI=magnetic resonance imaging; RMS=relapsing multiple sclerosis.

References: 1. Kesimpta [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp. 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. Hauser SL, Bar-Or A, Cohen JA, et al. Ofatumumab vs teriflunomide in relapsing multiple sclerosis: analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials. LB62. Poster presented at: 6th Congress of the European Academy of Neurology; May 23-26, 2020; Virtual. 4. Data on file. OMB157G (ofatumumab). Summary of clinical efficacy in relapsing multiple sclerosis. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019. 5. Data on file. OMB157 (ofatumumab). ASCLEPIOS I Final clinical study report. Novartis Pharmaceuticals Corp; East Hanover, NJ. November 2022. 6. Data on file. OMB157 (ofatumumab). Final clinical study report. Meta-analysis of ASCLEPIOS I/II. Novartis Pharmaceuticals Corp; East Hanover, NJ. November 2022.

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

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.

SEE IMPORTANT SAFETY INFORMATION

INDICATION

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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Choose POWERFUL efficacy: choose KESIMPTA® (ofatumumab)