LRA Randomized Controlled Trial (RCT)^1*

ERA RCT¹

*SAE and SI data from RCT portions of the LRA patient population included only placebo-controlled trials.

†Observed on study or within 30 days after the last ENBREL dose.

Long-standing RA (LRA) = Patients who failed at least 1 DMARD.

Early RA (ERA) = Patients with disease duration of ≤ 3 years.

• A serious adverse event (SAE) was defined as any adverse event that resulted in death, was life-threatening (i.e., any adverse event that placed the patient at immediate risk of death from the event as it occurred), required or prolonged inpatient hospitalization, resulted in a permanent or significant disability or incapacity, or resulted in a congenital anomaly or birth defect.¹
• A serious infection (SI) was defined as a SAE that was infectious.¹
• The safety profile in older patients is consistent with that of younger adult patients.³
  • Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.³

SAE and SI rates in LRA patients (events/pt-year)^1*

SAE and SI rates in ERA patients (events/pt-year)^1*

*Observed on study or within 30 days after the last ENBREL dose. The population for each year reflects all patients at the time of analysis who received at least 1 dose of study drug. Because completion of year milestones by patients is on a rolling basis, the yearly patient number may not reflect the entire cohort.

Through 9 years of observation, ENBREL has shown low malignancy rates in LRA and ERA patients.¹

• In clinical trials of all TNF inhibitors, more cases of lymphoma were seen compared to control patients. The risk of lymphoma may be up to several-fold higher in RA and psoriasis patients. The role of TNF inhibitors in the development of lymphoma is unknown.³
• In a randomized, placebo-controlled study of 180 patients with Wegener’s granulomatosis where ENBREL was added to standard treatment (including cyclophosphamide, MTX, and corticosteroids), patients receiving ENBREL experienced more noncutaneous solid malignancies than patients receiving placebo.³
• The use of ENBREL in patients with Wegener’s granulomatosis receiving immunosuppressive agents is not recommended. The use of ENBREL in patients receiving concurrent cyclophosphamide therapy is not recommended.³

Observed malignancies* in LRA patients at 9 years (events/pt-year)^1†

Observed malignancies* in ERA patients at 8 years (events/pt-year)^1†

*Excludes nonmelanoma skin cancers and in situ cancers except for bladder cancer.¹

†Observed on study or within 30 days after the last ENBREL dose. The population for each year reflects all patients at the time of analysis who received at least 1 dose of study drug. Because completion of year milestones by patients is on a rolling basis, the yearly patient number may not reflect the entire cohort.

Rates of Tuberculosis with ENBREL

• As of May 2006, among 20,070 global study patients across indications (28,308 patient-years of treatment), 3 total cases of TB were reported, all of which were in RA (approximately 0.01%).³
  • Of these global study patients, 15,438 were in the US and Canada (23,524 patient-years of treatment), among whom 1 case of TB was reported (approximately 0.007%).³
• As of August 2007†, among 25,306 global study patients across indications (34,034 patient-years of treatment), there were 5 total cases of TB identified (4 cases in RA, 1 case in AS).¹
• Infections, including serious infections, some fatal, have been observed in patients treated with ENBREL. TB has been observed in patients receiving TNF-blocking agents, including ENBREL.³

†The data cut was as of August 2007, except for one registry in which the data cut was October 2007.¹