Cyltezo (adalimumab-adbm, previously BI 695501) is an approved treatment to manage the symptoms of ankylosing spondylitis (AS). It is a Humira biosimilar developed by Boehringer Ingelheim Pharmaceuticals.

How Cyltezo works

AS is a chronic inflammatory condition caused by the immune system mistakenly attacking healthy tissues, resulting in damage and swelling. Cyltezo is a type of biological disease-modifying antirheumatic drug (DMARD). It acts to block part of the immune system and reduce the damaging inflammatory response.

Cyltezo is a biosimilar of AbbVie’s biological drug Humira. The active component of Humira is the antibody adalimumab. An antibody is a protein that has been designed to interact with a specific target. In this case, Cyltezo binds to and blocks the action of a protein called tumor necrosis factor alpha (TNFa).

TNFa is a cytokine, a protein that is part of the normal immune response and that causes inflammation. In AS patients, higher levels of TNFa can cause abnormal inflammation and persistent symptoms.

By blocking TNFa, Cyltezo aims to reduce inflammation and provide relief from the symptoms of AS.

Cyltezo in clinical trials

A Phase 3 clinical trial (NCT02137226) comparing Cyltezo to Humira in patients with rheumatoid arthritis (RA), called VOLTAIRE-RA, was used as evidence in applications to support the equivalence of the two drugs. The results demonstrated that there was no significant difference in the effectiveness and safety of the two drugs at 24 weeks of treatment.

On Aug. 29, 2017, Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) had approved Cyltezo for the treatment of active AS. This decision was based on the results of two clinical trials.

The first trial (NCT00085644), called ATLAS, was a placebo-controlled, double-blind, randomized, multicenter Phase 3 study assessing the effectiveness and safety of adalimumab in 315 adult patients with active AS. The results of the trial, published in the scientific journal Arthritis and Rheumatologyshowed that after 24 weeks of treatment, patients given Cyltezo had a significant reduction in disease activity compared to those given a placebo. This was assessed using several measures, including the Bath AS disease activity index (BASDAI), the visual analog score (VAS) for total back pain, and the duration of morning stiffness.

The second key Phase 3 trial (NCT00195819) assessed Cyltezo in 82 AS patients and demonstrated a similar safety and efficacy profile. The results, published in Arthritis and Rheumatology, showed a significant reduction in joint inflammation in Cyltezo-treated patients compared to those in the placebo group.

Both trials monitored the long-term safety of Cyltezo in patients for up to 260 weeks and showed that the therapy is safe for long-term use.

Further comparison trials — for example in patients with psoriasis (VOLTAIRE-X, NCT03210259) — are still ongoing. With these trials, Boehringer Ingelheim aims to prove that Cyltezo is interchangeable with Humira.

Other information

Cyltezo is administered as an under-the-skin injection from a pre-filled syringe. The most common side effects include injection site reactions, infections, headache, and rash. For the full list of adverse effects, see the prescribing information.

Cyltezo is currently not commercially available in the U.S. because Boehringer Ingelheim is involved in a legal battle with Humira developer AbbVie over patent issues. Meanwhile, Boehringer Ingelheim has also submitted a marketing authorization application (MAA) to the European Commission (EC). On Sept. 14, 2017, the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA), recommended that the application be accepted. A decision from the EC is expected by the fourth quarter of 2017.

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