ACTEMRA: A PROVEN OPTION FOR MTX-INTOLERANT PATIENTS OR PATIENTS WHO PREFER MONOTHERAPY 1,2

With 8 pivotal and supportive monotherapy RA studies, ACTEMRA offers an established treatment for your patients when MTX is not an option. 2-9

ACTEMRA monotherapy delivered superior efficacy compared to MTX across ACR scores 2

AMBITION—MONOTHERAPY*

Randomized, double-blind, 24-week, Phase III clinical study in MTX-naïve/-free* patients with moderately to severely active RA. The primary endpoint was ACR20 response at week 24. Patients were treated with ACTEMRA 8 mg/kg IV (every 4 weeks) or an escalating dose of MTX. MTX dose was initiated at 7.5 mg/week and increased to a maximum dose of 20 mg/week within 8 weeks.

*ACTEMRA is not indicated for the treatment of MTX-naïve patients with RA. ACTEMRA is indicated for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more DMARDs. The MTX dose was titrated over 8 weeks from 7.5 mg to a maximum of 20 mg weekly.

The recommended starting dose for ACTEMRA IV for adult patients is 4 mg/kg every 4 weeks followed by an increase to 8 mg/kg every 4 weeks based on clinical response.

ACR=American College of Rheumatology; DMARD=disease-modifying antirheumatic drug; MTX=methotrexate; RA=rheumatoid arthritis.

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SELECT IMPORTANT SAFETY INFORMATION

RISK OF SERIOUS INFECTIONS:

Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled.

Reported infections include:

  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before ACTEMRA use and during therapy. Treatment for latent infection should be initiated prior to ACTEMRA use.
  • Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
  • Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ACTEMRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Please see additional Important Safety Information below, and full Prescribing Information, including BOXED WARNING.

ACTEMRA may allow you to discontinue MTX 3

COMP-ACT evaluated whether patients who achieved low disease activity while on ACTEMRA + MTX maintained a clinical response following MTX discontinuation.

COMP-ACT—MAINTENANCE

Randomized, multicenter, double-blind, parallel-group, 52-week, Phase IV non-inferiority study (plus 8-week follow-up [N=718]).

Randomized patients exhibiting  ≥1.2 worsening of DAS28-ESR were allowed to continue treatment with the addition of an open-label DMARD after week 40.

Primary Endpoint: Comparison of mean change in DAS28-ESR score in the randomized cohort from weeks 24 to 40 between the monotherapy and combination arms.

Mean DAS28 over time in randomization cohort (from baseline to week 52) 3

The recommended starting dose of ACTEMRA SC for patients <100 kg is 162 mg administered subcutaneously (SC) every other week, followed by an increase to every week based on clinical response. The recommended starting dose of ACTEMRA SC for patients ≥100 kg is 162 mg administered subcutaneously every week.

§Dose escalation from Q2W to QW was allowed at week 12 in patients who did not achieve DAS28 ≤3.2. ACTEMRA + MTX dosage was adjusted every 12 weeks based on patients’ clinical responses.

Patients were only randomized at week 24 if DAS28-ESR ≤3.2 was achieved. If DAS28-ESR was not achieved, patients were assigned to an open-label arm and continued ACTEMRA + MTX until week 52.

Of the 296 patients randomized at week 24 to either receive ACTEMRA monotherapy or continue ACTEMRA + MTX, 2 were lost to follow-up.

DAS=disease activity score; ESR=erythrocyte sedimentation rate; Q2W=every-other-week dose; QW=every-week dose.