Actemra Receives New Indication to Treat Interstitial Lung Disease in Patients Diagnosed with Systemic Sclerosis

March 4, 2021 – The U.S. FDA has approved a new indication for Actemra® (tocilizumab), manufactured by Roche, to slow the rate of pulmonary function decline in adults who have systemic sclerosis-associated interstitial lung disease (SSc-ILD). Actemra is the first biologic therapy to receive FDA approval for SSc-ILD.

Systemic sclerosis (SSc), or scleroderma, is a progressive autoimmune condition in which the body’s immune system mistakenly attacks healthy tissue. SSc often leads to changes in the skin’s texture and appearance due to excess production of collagen. It can also cause lung tissues to harden and thicken, leading to interstitial lung disease (ILD) in approximately 80% of SSc patients. ILD is characterized by potentially life-threatening inflammation and scarring of the lungs.

In a clinical study, patients who received Actemra to treat SSc-ILD showed less decline from baseline than those who received a placebo. Decline was measured based on forced vital capacity (FVC), a measure of how much air a patient can exhale, and percent predicted forced vital capacity (ppFVC), a comparison of the patient’s observed FVC to what would be expected of a healthy person of the same age, gender, race, and height.

Recommended dosing under the new indication is 162mg administered once weekly via subcutaneous (SC) injection. Actemra for SC injection can be administered by the patient or a caregiver if the healthcare provider determines home use is appropriate. Although Actemra for SC injection is available in either a prefilled syringe or an ACTPen® autoinjector, use of the ACTPen has not been studied in SSc-ILD patients.

In addition, while Actemra is available for intravenous (IV) use, this route of administration is not FDA approved for the treatment of SSc-ILD.

Actemra first received FDA approval in 2010, and is also indicated to treat rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome.