Wednesday, 19 Feb 2020

You are here

TULIP2 - Anifrolumab Succeeds in Lupus

NEJM has published the results of the TULIP2 trial with anifrolumab, an alpha interferon blocker, in the treatment of systemic lupus erythematosus (SLE), showing significant improvement (over placebo) in multiple lupus outcome measures, including BICLA, SRI-4, CLASI and others. 

A total of 362 SLE patients were randomized to receive intravenous anifrolumab (300 mg) or placebo every 4 weeks for 48 weeks. The primary end point of this trial was a response at week 52 defined with the use of the British Isles Lupus Assessment Group (BILAG)–based Composite Lupus Assessment (BICLA). 

Patients were required to have moderate to severely active SLE, with a SLEDAI-2K score of 6 or higher (excluding points attributable to fever, lupus-related headache, or organic brain syndrome) and a score on the clinical SLEDAI-2K (SLEDAI-2K without laboratory results) of 4 or higher. At enrollment >70% of patients had a SLEDAI-2K score >10.  Patients remained on their background therapies (steroids ~80%, hydroxychloroquine ~70%, immunosuppressives nearly half) during the trial.

At 48 weeks the BICLA response was 47.8% in the anifrolumab group and 31.5% in the placebo group (P=0.001).

While over 80% of patients had a high alpha interferon gene signature, the response rates were similar when looking at all patients (48% versus 30.7%).

Herpes zoster (7.2% vs. 1,1%) and URI (21.7% vs. 9.9%) were more common in patients who received anifrolumab (vs. placebo). There was one death from pneumonia in the anifrolumab group.

These results contrast to the findings of the similar, previously reported, TULIP1, phase 3 trial that used the SRI-4 primary end point. 

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

BSR Guidelines for Giant Cell Arteritis

NICE has commissioned an update to the 2010 British Society for Rheumatology guideline for the management of giant cell arteritis, and proposed a total of 19 recommendations for the diagnosis and treatment of GCA.

PEXIVAS - Plasma Exhange Fails to Boost Outcomes in Severe AAV

The PEXIVAS study showed that plasma exchange did not reduce the incidence of death or ESKD in patients with severe ANCA–associated vasculitis.

Shingles Vaccine Lowers Risk of CVA

Shingles infection has been historically linked to an increased risk of stroke. A new study found that Zoster Vaccine Live, one type of shingles vaccination, may prevent stroke in some older adults.

EULAR Recommendations on Sjögren’s Syndrome

The European League Against Rheumatism (EULAR) has established an international collaborative group (EULAR SS Task Force) to develop the first EULAR evidence and consensus-based recommendations for the management of patients with Sjogens syndrome (SjS).

Steroid-Sparing Effect of Tocilizumab in Refractory Takayasu Arteritis

A controlled clinical trial has shown that giving the IL-6 receptor antibody, tocilizumab (TCZ), to  patients with Takayasu arteritis (TAK) results in clinical efficacy and has a steroid sparing efffect.