Saphnelo: New FDA-approved drug for lupus?

A potential new drug for lupus–
​here are some early facts

UPDATE: Anifrolumab (Saphnelo) was FDA-approved on August 2, 2021

Saphnelo: The next FDA-approved drug to treat lupus
Saphnelo: The next FDA-approved drug to treat lupus

Anifrolumab (Saphnelo) has the lupus community excited as the next FDA-approved drug for lupus.
Pronounced saf-NEH’-low

Saphnelo–the 2021 FDA-approved drug to treat lupus (at least the next biologic for systemic lupus). I received this email on 4/18/21 announcing the brand name!, I have never seen a brand name announced before official FDA-approval. Someone must know something I do not know. I suspect that anifrolumab will be the next FDA-approved drug for lupus. Did they get wind of a pending nod from the FDA? This drug has impressive results from its research studies. Let me share a few so all SLE patients who have failed other medications realize that there is HOPE!

Cutaneous lupus responded very well to anifrolumab or Saphnelo

anifrolumab (Saphnelo) has impressive results. Many patients with cutaneous (skin) lupus had total to near total clearing of their skin inflammation as shown in this pic … NOTE… this picture comes directly from the following research study found on the internet. The photo is owned by the ACR’s Arthritis and Rheumatology journal: Furie R, Khamashta M, Merrill JT, Werth VP, et al; CD1013 Study Investigators. Anifrolumab, an Anti-Interferon-α Receptor Monoclonal Antibody, in Moderate-to-Severe Systemic Lupus Erythematosus. Arthritis Rheumatol. 2017 Feb;69(2):376-386. doi: 10.1002/art.39962. PMID: 28130918; PMCID: PMC5299497.

Research results “in a nut shell” in easy-to-understand language:

The clinical trials for anifrolumab were called the TULIP trials
TULIP comes from the full research study name: ​Treatment of Uncontrolled Lupus via the Interferon PathwayHow does it work?

Most (70%) of systemic lupus erythematosus (SLE) patients have high levels of interferons
Interferons cause inflammation of organs, leading to permanent organ damage
Anifrolumab competes with interferon by attaching to the attachments (receptors) on immune system cells
Normally, when interferons bind to those receptors, the immune system cells become more active
Then they alert more immune system cells to become more active and attack body organs
Anifrolumab decreases this cascade of events from happening
This leads to less inflammation
It is a biologic monoclonal antibody, so it will be expensive!

Anifrolumab (Saphnelo) works differently than any drug used in the past to treat lupus!
1st in its class! With it aimed at a major cause of lupus (high type-1 interferon levels), it should be the next FDA-approved drug for lupus. 

​Saphnelo, the next FDA-approved drug to treat lupus: How is it given?

Saphnelo is given intravenously (IV), 300 mg, every 4 weeks (I suspect it will be 300 mg)

What were the research results?
There was a 90% reduction of interferons at 6 months in the patients who started off with high levels
Other labs measuring lupus inflammation improved (anti-dsDNA, C3, C4, CH50)
Low white blood cell counts and low platelet counts improved

What other good things did it do for the SLE patients?

They had less disease activity
Even patients who started with normal interferon levels overall improved
In TULIP-2: 57% (46 placebo vs 72 anifrolumab patients) more patients who started with high interferon levels met the primary endpoint with anifrolumab
… 58% more patients! Impressive!
When looking at all patients, a 51% higher number of patients responded to anifrolumab, including those with normal interferon levels!
You do not have to have high interferon levels to respond!
Close to twice as many patients were able to decrease their steroids to goal (25 placebo vs 45 on anifrolumab)
Lower steroids is important because higher doses of steroids cause organ damage
Anifrolumab reduced lupus flares

It especially worked well for cutaneous lupus

Look at the picture above from one of the studies
This patient had an amazing improvement. Many others did just as well
They measured skin activity with a CLASI score and looked for more than a 50% improvement
CLASI stands for 
Cutaneous Lupus Erythematosus Disease Area and Severity Index

Twice as many anifrolumab patients responded: No wonder Saphnelo is the next FDA-approved drug to treat lupus

     -The numbers were 25% of the placebo cutaneous lupus patients responded, while 49% on anifrolumab did 

How fast does it work?

Reduced disease activity was seen as early as 2 months

What were the side effects of anifrolumab

When comparing side effects, it is important to know that the placebo patients were not truly “placebo”
They were receiving standard of care therapy
In other words, most were on immunosuppressants and steroids that cause side effects themselves
The patients on anifrolumab were also on immunosuppressants and steroids
Therefore sorting out what anifrolumab may do vs the other drugs is very difficult

But, here are the numbers (combination of three different anifrolumab research studies):

Around 87% of anifrolumab patients and 80% of placebo patients had side effects
This include nuisance, mild side effects
The most common were viral upper respiratory tract (URI) and throat infections (cold-like infections)
Infusion reactions were the other most common
For example, 10% of the placebo (standard of care) patients had URIs, 18% on anifrolumab did
This is not surprising, interferon is important for fighting viral infections
Shingles occurred in around 6% of anifrolumab patients and 1%-2% of placebo patients
Again, not surprising since shingles is due to chicken pox virus
6% of anifrolumab patients had to stop treatment due to side effects; 3% of placebo patients had to stop

What patients were not studied?

Patients with severe kidney inflammation (lupus nephritis, LN), brain, and nerve lupus (neuropsychiatric) were not
Therefore, we do not know if it works in them
However, I will go out on a limb and predict it will help LN patients
We know that interferon plays a role in LN
Just because we do not have study results for severe LN patients, this does not mean it does not work

What could possibly keep the FDA from approving it?

In the first TULIP-1 trial, it did not meet its primary endpoint (research goal called the SRI-4)
This could get some voting members to vote “no” for approval
However, lupus experts realize how hard it is to prove that lupus drugs work
They evaluated how the drug performed in the 1st trial
Patients did have significant improvements
They were able to lower their steroids and there was marked improvements in cutaneous lupus
One criticism is that some patients changed their NSAID (like ibuprofen) during the study
These patients were automatically labeled as a drug failure, though many of them had great responses
So they changed the primary endpoint for TULIP-2 based on their analysis of TULIP-1
The TULIP-2 trial did meet its primary end point

Bottom lines- Saphnelo, the next FDA-approved drug to treat lupus:

– Impressive results, especially for skin lupus
– Low rate of side effects (colds, sore throats, infusion reactions, shingles are the most important)
– Get your Shingrix shot before treatment
– I have a list of SLE patients who have failed everything who need to try this drug if it is FDA-approved!

As of August 2, 2021, anifrolumab became the next FDA-approved drug for lupus!

Good luck to AstraZeneca who is the manufacturer of Saphnelo

Update: August 2021

2020 and 2021 were monumental years for people who have lupus. Belimumab (Benlysta) became the first FDA-approved drug for lupus nephritis December 17, 2020. Voclosporin (Lupkynis) became the second FDA-approved drug for lupus nephritis on January 22, 2021 with the advantage of its being a pill rather than an injection. Then, anifrolumab (Saphnelo) was FDA-approved to treat lupus (the systemic form) on August 2, 2021!


Don Thomas, MD, author of “The Lupus Encyclopedia” and “The Lupus Secrets




Furie R, Khamashta M, Merrill JT, et al.; for the CD1013 Study Investigators. Anifrolumab, an anti-interferon-alpha receptor monoclonal antibody,in moderate-to-severe systemic lupus erythematosus.Arthritis Rheumatol. 2017;69(2):376–86.Furie R, Morand EF, Bruce IN, Manzi S, Kalunian K, Vital EM, et al. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019;1(4):e208–19.

Morand EF, Furie R, Tanaka Y, Bruce IN, Askanase AD, Richez C, et al.; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020;382(3): 211–21.

Tanaka Y, Takeuchi T, Okada M, Ishii T, Nakajima H, Kawai S, et al. Safety and tolerability of anifrolumab, a monoclonal antibody targeting type I interferon receptor, in Japanese patients with systemic lupus erythematosus: a multicenter, phase 2, open label study. Mod Rheumatol. 2020;30(1):101–8.

Tanaka Y, Tummala R. Anifrolumab, a monoclonal antibody to the type I interferon receptor subunit 1, for the treatment of systemic lupus erythematosus: an overview from clinical trials. Mod Rheumatol. 2021 Jan;31(1):1-12. doi: 10.1080/14397595.2020.1812201. Epub 2020 Sep 17. PMID: 32814461.

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  1. This sounds amazing! I have been waiting for a drug like anifrolumab to come along.. I suffer terrible from full body rashes with my SLE along with other symptoms.
    I have tried several drugs with no luck in controlling my flares. I was hoping to start IVig but my hospital wants me to go through a protocol of 2 other meds first.
    This drug looks so promising for a lupus patient like myself and others who suffer with horrendous rashes. I will be speaking to my doctors about anifrolumab.

  2. Good luck… if you go on Saphnelo, let us know how you do on it!

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