Saphnelo (anifrolumab-fnia) for lupus
Fact-checked by What is Saphnelo for lupus?
Saphnelo (anifrolumab-fnia) is an injectable therapy approved for moderate to severe systemic lupus erythematosus (SLE), the most common form of lupus.
In lupus, the immune system mistakenly attacks the body’s own healthy tissues. Interferons, a group of pro-inflammatory signaling molecules, are known to play a role in these damaging attacks.
Saphnelo is an antibody therapy that blocks interferon activity, thereby preventing the activation of pro-inflammatory signaling pathways that drive lupus. This is expected to ease symptoms and lower overall disease activity.
Marketed by AstraZeneca, Saphnelo can be administered by a healthcare provider via a monthly into-the-vein (intravenous) infusion or self-administered as a weekly under-the-skin (subcutaneous) injection.
Therapy snapshot
| Brand name | Saphnelo |
| Chemical name | Anifrolumab-fnia |
| Usage | Used to treat adults with moderate to severe SLE |
| Administration | Intravenous infusion or subcutaneous injection |
Who can take Saphnelo?
Saphnelo is approved in the U.S. for adults with moderate to severe SLE who are receiving standard therapy. It has not been evaluated in patients with severe active lupus nephritis, a kidney complication of lupus, or people with severe active lupus that affects the brain and spinal cord, and is thus not recommended in these situations.
The medication is contraindicated for, or should not be used by, people with a history of anaphylaxis, a life-threatening systemic immune reaction, to the therapy’s active ingredient.
Saphnelo is also approved for the treatment of adults with SLE in the European Union and Canada, although specific indications may vary.
How is Saphnelo administered?
When delivered intravenously, Saphnelo is administered by a healthcare provider once every four weeks at a recommended dose of 300 mg. The infusions take about 30 minutes.
The subcutaneous formulation comes in prefilled syringes or a single-dose autoinjector, and can be administered by patients or caregivers after proper training. The injections are given into the thigh, abdomen, or upper arm at a recommended dose of 120 mg, once weekly.
Saphnelo in clinical trials
The approval of the intravenous formulation of Saphnelo was supported by three clinical trials that involved adults with moderate or severe SLE.
Treatment responses were evaluated with the SLE Responder Index (SRI-4) and the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA). In general, a treatment response in these measures indicates that disease severity has decreased, with no evidence of new disease activity.
- The Phase 2 MUSE trial (NCT01438489) showed that SRI-4 response rates were significantly higher with the now-approved dose of Saphnelo than with a placebo (62.8% vs. 38.8%) after a year of treatment. BICLA response rates were also higher.
- The Phase 3 trials TULIP-1 (NCT02446912) and TULIP-2 (NCT02446899) similarly showed that BICLA response rates were higher after a year of treatment with Saphnelo at its approved dose than with a placebo. In TULIP-2, significantly more people on Saphnelo reduced their corticosteroid use by at least 25%, and SRI-4 response rates were also higher.
The approval of the subcutaneous formulation of Saphnelo was supported by the Phase 3 TULIP-SC trial (NCT04877691). The data showed that this version of the therapy also led to statistically significant and clinically meaningful reductions in disease activity compared with a placebo.
Saphnelo side effects
The most common side effects of Saphnelo include:
- the common cold
- upper respiratory tract infections
- bronchitis
- infusion-related reactions
- herpes zoster infection
- cough
Saphnelo also comes with warnings for the following adverse events:
- serious infections, which may be fatal
- severe immune reactions (hypersensitivity), including anaphylaxis
Saphnelo should not be started in people with active infections, and treatment may need to be paused if a new infection occurs. Patients should also talk with their care providers about which vaccines are safe to receive before starting Saphnelo and while receiving it.
Immune-suppressing treatments like Saphnelo may increase the risk of cancer, although the specific relationship between Saphnelo and cancer is not known.
The medication is also not recommended for use with other biologic therapies, a class of targeted immune-suppressing treatments used for lupus, as these combinations have not been studied.
Lupus News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
