POST HOC ANALYSIS

In ASCLEPIOS I and II vs Aubagio: Primary end point, ARR 51% (0.11 vs 0.22), 59% (0.10 vs 0.25). Key secondary end points: number of Gd+ T1 lesions per scan 98% (0.01 vs 0.45), 94% (0.03 vs 0.51); annualized rate of new or enlarging T2 lesions 82% (0.72 vs 4.00), 85% (0.64 vs 4.15); 3-month CDP 34% (10.9 vs 15.0).

KESIMPTA® (ofatumumab) post hoc analysis of pooled data from ASCLEPIOS I and II

KESIMPTA NEDA-3 outcomes

Review ASCLEPIOS I and II Study Design

No evidence of disease activity (NEDA-3)

Post hoc analysis of ASCLEPIOS I and II studies2

Post hoc analysis of ASCLEPIOS

I and II studies2

Chart showing Kesimpta post hoc analysis of ASCLEPIOS studies.

Up to 9 out of 10 patients
taking KESIMPTA achieved
NEDA-3 in year 2

No conclusions of clinical outcomes can be drawn.

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

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NEDA-3 post hoc analysis study design

POPULATION

All patients from the pivotal trial full analysis set population (all randomized patients with assigned treatments) were included in the intent-to-treat principle, but patients who discontinued from the study drug prematurely for reasons other than "lack of efficacy" or "death" and had NEDA-3 before early discontinuations were excluded.3

METHODS

The outcomes presented here are the proportion of study patients within a treatment group who met the NEDA-3 criteria vs those who did not. The proportion of patients meeting NEDA-3 criteria was analyzed cross-sectionally in time intervals including year 1 (month 0-12) or in year 2 (month 12-24).3

NEDA-3 Criteria3

Within the prespecified time period (ie, 0-12 months and 12-24 months), patients who achieved NEDA-3 experienced no

  • 6-month CDP
  • Confirmed relapse
  • ≥1 Gd+ T1 lesions
  • ≥1 T2 lesions
  • Discontinuation from the study drug due to either lack of efficacy or death

% Achieving NEDA-3

Calculated as n/N, where n is the number of patients who achieved NEDA-3 and N is the total number of patients in the treatment group.2

Re-baselining After Year 1

  1. 1. For the year 2 (12-24 month) analysis, all components of NEDA-3 were re-baselined, meaning outcomes were recalculated relative to the month 12 baseline vs month 03
  2. 2. Analyses of NEDA-3 using a re-baselining approach may more closely reflect the effects of DMTs4
  3. 3. Re-baselining is utilized to reflect a truer representation of a DMT's steady state of efficacy unconfounded by any initial disease activity carried over from baseline and recent prebaseline disease state4

LIMITATIONS

This analysis considers patients without evidence of disease activity (which may also include patients with partially missing information) as NEDA-3. A sensitivity analysis was conducted for the population of patients who completed the full 24 months of treatment.3

'My doctor recommended Kesimpta to help reduce the number of relapses I experience.' - Kristin: mother, real estate agent, Kesimpta patient.

My doctor recommended KESIMPTA to help
reduce the number of relapses I experience.

Kristin: mom, real estate agent, KESIMPTA patient

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

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VISIT COVERMYMEDS®

ARR=annualized relapse rate; CDP=confirmed disability progression; CI=confidence interval; DMT=disease-modifying therapy; Gd+=gadolinium-enhancing; K-M=Kaplan-Meier; MOA=mechanism of action; MS=multiple sclerosis.

References: 1. 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. 2. Data on file. OMB157G (ofatumumab). Summary of clinical efficacy in relapsing multiple sclerosis. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019. 3. Data on file. OMB157G (ofatumumab) OMB157G 5.3.5.3. Statistical overview. Novartis Pharmaceuticals Corp; East Hanover, NJ. December 2019. 4. 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.

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

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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