SAFETY PROFILE WAS ESTABLISHED IN 5 SAPHNELO CLINICAL TRIALS INVOLVING MORE THAN ~2000 PATIENTS*,1-6
| ADVERSE REACTION | SAPHNELO IV + ST (N=459), % |
Placebo + ST (N=466), % |
|---|---|---|
| Upper respiratory tract infection† | 34 | 23 |
| Bronchitis | 11 | 5.2 |
| Infusion-related reactions | 9.4 | 7.1 |
| Herpes zoster | 6.1 | 1.3 |
| Cough | 5.0 | 3.2 |
| Respiratory tract infection | 3.3 | 1.5 |
| Hypersensitivity | 2.8 | 0.6 |
| ADVERSE REACTION | SAPHNELO SC + ST (N=185), % |
Placebo + ST (N=182), % |
|---|---|---|
| Injection-site reaction‡ | 15.7 | 15.4 |
| Non-opportunistic serious infections | 7.0 | 3.3 |
| Herpes zoster | 3.8 | 1.1 |
See study design and key study limitations.
THE SAFETY PROFILE OBSERVED FOR SAPHNELO ADMINISTERED SUBCUTANEOUSLY WAS CONSISTENT WITH THE KNOWN SAFETY PROFILE OF SAPHNELO ADMINISTERED INTRAVENEOUSLY.†,1
DATA FROM LONG-TERM PLACEBO-CONTROLLED SAFETY STUDY3
| LTE SAPHNELO IV 300 mg + ST (N=257), % |
LTE Placebo + ST (N=112), % |
|
|---|---|---|
| Any SAE (including events with outcome of death) | 22.6 | 25.0 |
| Any AESI | 29.2 | 21.4 |
| Discontinuation due to any AE | 6.6 | 7.1 |
During the LTE study, the most common serious infections were COVID-19 and pneumonia.1
See study design and key study limitations.
THE OVERALL LONG-TERM SAFETY PROFILE OF SAPHNELO ADMINISTERED INTRAVENEOUSLY WAS CONSISTENT WITH MUSE AND TULIP TRIALS.1,2
AE=adverse event; AESl=adverse event of special interest; IV=intravenous; LTE=long-term extension; MUSE=MEDl-546 in Subjects with Systemic Lupus Erythematosus (Trial 1); SAE=serious adverse event; SC=subcutaneous; ST=standard therapy; TULIP=Treatment of Uncontrolled Lupus via the Interferon Pathway.
CONTRAINDICATION
Known history of anaphylaxis with SAPHNELO.
WARNINGS AND PRECAUTIONS
- Serious Infections: Serious and sometimes fatal infections have occurred in patients receiving immunosuppressive agents, including SAPHNELO. SAPHNELO increases the risk of respiratory infections and herpes zoster. Use caution in patients with severe or chronic infections. Avoid initiating treatment during an active infection and consider interrupting therapy in patients who develop a new infection during treatment
- Hypersensitivity Reaction Including Anaphylaxis: Serious hypersensitivity reactions (including anaphylaxis) have been reported following SAPHNELO administration. Events of angioedema have also been reported. Other hypersensitivity reactions and infusion-related reactions have occurred following administration of SAPHNELO. SAPHNELO should be administered by healthcare providers prepared to manage hypersensitivity reactions, including anaphylaxis and infusion-related reactions, if they occur. Immediately interrupt administration and initiate appropriate therapy if a serious infusion-related or hypersensitivity reaction (eg, anaphylaxis) occurs
- Malignancy: There is an increased risk of malignancies with the use of immunosuppressants. The impact of SAPHNELO on the potential development of malignancies is not known
- Immunization: Avoid the use of live or live-attenuated vaccines in patients treated with SAPHNELO
- Use With Biologic Therapies: SAPHNELO is not recommended for use in combination with other biologic therapies, including B-cell targeted therapies
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥5%) are nasopharyngitis, upper respiratory tract infections, bronchitis, infusion-related reactions, herpes zoster and cough.
In the controlled clinical trials, the incidence of infusion-related reactions was 9.4% in patients while on treatment with SAPHNELO and 7.1% in patients on placebo. Infusion-related reactions were mild to moderate in intensity; the most common symptoms were headache, nausea, vomiting, fatigue, and dizziness.
USE IN SPECIFIC POPULATIONS
Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to SAPHNELO during pregnancy. For more information about the registry or to report a pregnancy while on SAPHNELO, contact AstraZeneca at 1-877-693-9268.
There are insufficient data on the use of SAPHNELO in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. Advise female patients to inform their healthcare provider if they intend to become pregnant during therapy, suspect they are pregnant or become pregnant while receiving SAPHNELO.
Lactation: No data are available regarding the presence of SAPHNELO in human milk, the effects on the breastfed child, or the effects on milk production.
Pediatric Use: The safety and efficacy of SAPHNELO in pediatric patients less than 18 years of age has not been established.
INDICATION
SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.
Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use is not recommended in these situations.
INDICATION
SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.
Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use is not recommended in these situations.
Please see full Prescribing Information, including Patient Information.
You may report side effects related to AstraZeneca products.Opens new window 
.
References: 1. Morand EF, van Vollenhoven R, Furie RA, et al. LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials. Supplementary appendix. Ann Rheum Dis. 2025;84(5):777-788. 2. SAPHNELO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. 3. Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020;382(3):211-221. 4. Furie RA, Morand EF, Bruce IN, et al; TULIP-1 Study Investigators. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019;1(4):e208-e219. 5. US Department of Health and Human Services Food and Drug Administration. Guidance for Industry systemic lupus erythematosus—Developing medical products for treatment. Updated June 5, 2020. Accessed April 21, 2026. https://www.fda.gov/media/71150/download
References: 1. Thong B, Olsen NJ. Systemic lupus erythematosus diagnosis and management. Rheumatology (Oxford). 2017;56(suppl1):i3-i13. 2. Allen ME, Rus V, Szeto GL. Leveraging heterogeneity in systemic lupus erythematosus for new therapies. Trends Mol Med. 2021;27(2):152-171. 3. Bertsias G, Cervera R, Boumpas DT. Systemic lupus erythematosus: pathogenesis and clinical features. In: Bijlsma J (ed). EULAR Textbook on Rheumatic Diseases. London: BMJ Group; 2012:476-505. 4. Kaul A, Gordon C, Crow MK, et al. Systemic lupus erythematosus. Nat Rev Dis Primers. 2016;2:16039. 5. Izmirly PM, Parton H, Wang L, et al. Prevalence of systemic lupus erythematosus in the United States: estimates from a meta-analysis of the Centers for Disease Control and Prevention National Lupus Registries. Arthritis Rheumatol. 2021;73(6):991-996. 6. Mauri C, Menon M. The many faces of type I interferon in systemic lupus erythematosus. J Clin Invest. 2015;125(7):2562-2564. 7. Niewold TB, Clark DN, Salloum R, Poole BD. Interferon alpha in systemic lupus erythematosus. J Biomed Biotechnol. 2010;2010:948364. 8. Crow MK. Type I interferon in the pathogenesis of lupus. J Immunol. 2014;192(12):5459-5468. 9. Lauwerys BR, Ducreux J, Houssiau FA. Type I interferon blockade in systemic lupus erythematosus: where do we stand? Rheumatology (Oxford). 2014;53(8):1369-1376. 10. Hoffman RW, Merrill JT, Alarcón-Riquelme MME, et al. Gene expression and pharmacodynamic changes in 1,760 systemic lupus erythematosus patients from two phase III trials of BAFF blockade with tabalumab. Arthritis Rheumatol. 2017;69(3):643-654. 11. Becker AM, Dao KH, Han BK, et al. SLE peripheral blood B cell, T cell and myeloid cell transcriptomes display unique profiles and each subset contributes to the interferon signature. PLoS One. 2013;8(6):e67003. 12. Jefferies CA. Regulating IRFs in IFN driven disease. Front Immunol. 2019;10:325. 13. Mai L, Asaduzzaman A, Noamani B, et al. The baseline interferon signature predicts disease severity over the subsequent 5 years in systemic lupus erythematosus. Arthritis Res Ther. 2021;23(1):29.
References: 1. SAPHNELO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. 2. Mullard A. FDA approves AstraZeneca’s anifrolumab for lupus. Nat Rev Drug Discov. 2021;20(9):658. doi:10.1038/d41573-021-00139-y. 3. Crow MK, Olferiev M, Kirou KA. Type I interferons in autoimmune disease. Annu Rev Pathol. 2019;14:369-393. 4. Wahren-Herlenius M, Dörner T. Immunopathogenic mechanisms of systemic autoimmune disease. Lancet. 2013;382(9894):819-831. 5. Morawski PA, Bolland S. Expanding the B cell-centric view of systemic lupus erythematosus. Trends Immunol. 2017;38(5):373-382. 6. Crow MK. Type I interferon in the pathogenesis of lupus. J Immunol. 2014;192(12):5459-5468. 7. Rönnblom L, Leonard D. Interferon pathway in SLE: one key to unlocking the mystery of the disease. Lupus Sci Med. 2019;6(1):e000270.
References: 1. Ohmura K. Which is the best SLE activity index for clinical trials? Mod Rheumatol. 2021;31(1):20-28. 2. SAPHNELO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 3. Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020;382(3):211-221. 4. Furie RA, Morand EF, Bruce IN, et al; TULIP-1 Study Investigators. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019;1(4):e208-e219. 5. Morand EF, Furie RA, Bruce IN, et al. Efficacy of anifrolumab across organ domains in patients with moderate-to-severe systemic lupus erythematosus: a post-hoc analysis of pooled data from the TULIP-1 and TULIP-2 trials. Lancet Rheumatol. 2022;4(4):e282-e292. 6. Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus. Supplementary appendix and Protocol. N Engl J Med. 2020;382(3):211-221. 7. Mikdashi J, Nived O. Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research. Arthritis Res Ther. 2015;17(1):183. 8. Furie RA, Morand EF, Bruce IN, et al; TULIP-1 Study Investigators. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Supplementary appendix. Lancet Rheumatol. 2019;1(4):e208-e219. 9. Morand EF, van Vollenhoven R, Furie RA, et al. LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials. Ann Rheum Dis. 2025;84(5):777-788. 10. Data on File, REF-215956. AstraZeneca Pharmaceuticals LP. 11. US Department of Health and Human Services Food and Drug Administration. Guidance for Industry systemic lupus erythematosus—Developing medical products for treatment. Updated June 5, 2020. Accessed March 19, 2025. https://www.fda.gov/media/71150/download 12. Mosca M, Amoura Z, Weinmann-Menke J, et al. Attainment of LLDAS and DORIS remission during anifrolumab treatment: interim results from a multinational, observational, post-launch study of treatment effectiveness in the real world. Abstract presented at: European Congress of Rheumatology (EULAR) 2025; June 11-14, 2025; Barcelona, Spain. 13. Mosca M, Emmas C, Nekeman-Nan C, et al. Anifrolumab Study for Treatment Effectiveness in the Real World ASTER among patients with systemic lupus erythematosus, protocol for an international observational effectiveness study. BMJ Open. 2024;14(11):e086055. 14. Morand EF, van Vollenhoven R, Furie RA, et al. LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials. Supplementary appendix. Ann Rheum Dis. 2025;84(5):777-788. 15. Data on File, REF-173552. AstraZeneca Pharmaceuticals LP. 16. Kalunian KC, Furie R, Morand EF, et al. A randomized, placebo-controlled phase III extension trial of the long-term safety and tolerability of anifrolumab in active systemic lupus erythematosus. Arthritis Rheumatol. 2023;75(2):253-265. 17. Data on File, REF-173556. AstraZeneca Pharmaceuticals LP. 18. Kalunian KC, Furie R, Morand EF, et al. A randomized, placebo-controlled phase III extension trial of the long-term safety and tolerability of anifrolumab in active systemic lupus erythematosus. Supplementary appendix. Arthritis Rheumatol. 2023;75(2):253-265. 19. Kyttaris V, Atefi G, Persons D, Withrow D, Binka M. Reduction in oral corticosteroid use during anifrolumab therapy: observations from a real-world cohort of adults with systemic lupus erythematosus. Poster presented at: ACR Convergence 2024; November 14-19, 2024; Washington, DC. Poster 2438. 20. Kyttaris V, Binka M, Atefi G, et al. Renal outcomes in patients treated with anifrolumab for systemic lupus erythematosus in the US: findings from a real-world study. Poster presented at: European Alliances of Associations for Rheumatology (EULAR) 2024 European Congress of Rheumatology (ECR) Conference; June 12-15, 2024; Vienna, Austria. Poster POS1067. 21. Touma Z, Bruce IN, Furie R, et al. Reduced organ damage accumulation in adult patients with SLE on anifrolumab plus standard of care compared to real-world external controls. Ann Rheum Dis. 2025;84(5):767-776. 22. Touma Z, Bruce IN, Furie R, et al. Treatment with anifrolumab prevents long-term cardiovascular damage accrual compared with real-world standard of care in patients with systemic lupus erythematosus: findings from the LASER study. Abstract presented at ACR 2025. 23. Gladman D, Ginzler E, Goldsmith C, et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum. 1996;39(3):363-369. 24. ClinicalTrials.gov Trial NCT02446912. Efficacy and safety of two doses of anifrolumab compared to placebo in adult subjects with active systemic lupus erythematosus. Accessed April 27, 2025. https://clinicaltrials.gov/study/NCT02446912 25. ClinicalTrials.gov Trial NCT02794285. Long term safety of anifrolumab in adult subjects with active systemic lupus erythematosus (TULIP SLE LTE). Accessed February 3, 2025. https://classic.clinicaltrials.gov/ct2/show/NCT02794285 26. ClinicalTrials.gov. Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus (Tulip SC). August 21, 2025. https://clinicaltrials.gov/study/NCT04877691#participation-criteria 27. Furie R, Khamashta M, Merrill JT, et al; CD7073 Study Investigators. Anifrolumab, an anti-interferon-a receptor monoclonal antibody, in moderate-to-severe systemic lupus erythematosus. Arthritis Rheumatol. 2017;69(2):376-386.
References: 1. SAPHNELO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. 2. Kalunian KC, Furie R, Morand EF, et al. A randomized, placebo-controlled phase III extension trial of the long-term safety and tolerability of anifrolumab in active systemic lupus erythematosus. Arthritis Rheumatol. 2023;75(2):253-265. 3. Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020;382(3):211-221. 4. Furie RA, Morand EF, Bruce IN, et al; TULIP-1 study investigators. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019;1(4):e208-e219. 5. Furie R, Khamashta M, Merrill JT, et al; CD1013 Study Investigators. Anifrolumab, an anti–interferon-α receptor monoclonal antibody, in moderate-to-severe systemic lupus erythematosus. Arthritis Rheumatol. 2017;69(2):376-386. 6. Manzi S, Bruce IN, Morand EF, et al; TULIP-SC Investigators. Efficacy and safety of subcutaneous anifrolumab in systemic lupus erythematosus: a randomized, phase 3 study. Arthritis Rheumatol. Published online December 29, 2025. doi:10.1002/art.70041
Reference: 1. SAPHNELO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026.
References: 1. Ohmura K. Which is the best SLE activity index for clinical trials? Mod Rheumatol. 2021;31(1):20-28. 2. SAPHNELO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. 3. Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020;382(3):211-221. 4. Furie RA, Morand EF, Bruce IN, et al; TULIP-1 Study Investigators. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019;1(4):e208-e219. 5. Morand EF, Furie RA, Bruce IN, et al. Efficacy of anifrolumab across organ domains in patients with moderate-to-severe systemic lupus erythematosus: a post-hoc analysis of pooled data from the TULIP-1 and TULIP-2 trials. Lancet Rheumatol. 2022;4(4):e282-e292. 6. Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus. Supplementary appendix and Protocol. N Engl J Med. 2020;382(3):211-221. 7. Mikdashi J, Nived O. Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research. Arthritis Res Ther. 2015;17(1):183. 8. Furie RA, Morand EF, Bruce IN, et al; TULIP-1 Study Investigators. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Supplementary appendix. Lancet Rheumatol. 2019;1(4):e208-e219. 9. Morand EF, van Vollenhoven R, Furie RA, et al. LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials. Ann Rheum Dis. 2025;84(5):777-788. 10. Data on File, REF-215956. AstraZeneca Pharmaceuticals LP. 11. US Department of Health and Human Services Food and Drug Administration. Guidance for Industry systemic lupus erythematosus—Developing medical products for treatment. Accessed January 29, 2026. https://www.fda.gov/media/71150/download 12. Mosca M, Amoura Z, Weinmann-Menke J, et al. Attainment of LLDAS and DORIS remission during anifrolumab treatment: interim results from a multinational, observational, post-launch study of treatment effectiveness in the real world. Abstract presented at: European Congress of Rheumatology (EULAR) 2025; June 11-14, 2025; Barcelona, Spain. 13. Mosca M, Emmas C, Nekeman-Nan C, et al. Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) among patients with systemic lupus erythematosus: protocol for an international observational effectiveness study. BMJ Open. 2024;14(11):e086055. 14. Morand EF, van Vollenhoven R, Furie RA, et al. LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials. Supplementary appendix. Ann Rheum Dis. 2025;84(5):777-788. 15. Data on File, REF-173552. AstraZeneca Pharmaceuticals LP. 16. Kalunian KC, Furie R, Morand EF, et al. A randomized, placebo-controlled phase III extension trial of the long-term safety and tolerability of anifrolumab in active systemic lupus erythematosus. Arthritis Rheumatol. 2023;75(2):253-265. 17. Data on File, REF-173556. AstraZeneca Pharmaceuticals LP. 18. Kalunian KC, Furie R, Morand EF, et al. A randomized, placebo-controlled phase III extension trial of the long-term safety and tolerability of anifrolumab in active systemic lupus erythematosus. Supplementary appendix. Arthritis Rheumatol. 2023;75(2):253-265. 19. Kyttaris V, Atefi G, Persons D, Withrow D, Binka M. Reduction in oral corticosteroid use during anifrolumab therapy: observations from a real-world cohort of adults with systemic lupus erythematosus. Poster presented at: ACR Convergence 2024; November 14-19, 2024; Washington, DC. Poster 2438. 20. Kyttaris V, Binka M, Atefi G, et al. Renal outcomes in patients treated with anifrolumab for systemic lupus erythematosus in the US: findings from a real-world study. Poster presented at: European Alliances of Associations for Rheumatology (EULAR) 2024 European Congress of Rheumatology (ECR) Conference; June 12-15, 2024; Vienna, Austria. Poster POS1067. 21. Touma Z, Bruce IN, Furie R, et al. Reduced organ damage accumulation in adult patients with SLE on anifrolumab plus standard of care compared to real-world external controls. Ann Rheum Dis. 2025;84(5):767-776. 22. Touma Z, Bruce IN, Furie R, et al. Treatment with anifrolumab prevents long-term cardiovascular damage accrual compared with real-world standard of care in patients with systemic lupus erythematosus: findings from the LASER study. Abstract presented at ACR 2025. 23. Gladman D, Ginzler E, Goldsmith C, et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum. 1996;39(3):363-369. 24. ClinicalTrials.gov Trial NCT02446912. Efficacy and safety of two doses of anifrolumab compared to placebo in adult subjects with active systemic lupus erythematosus. Accessed April 27, 2025. https://clinicaltrials.gov/study/NCT02446912 25. ClinicalTrials.gov Trial NCT02794285. Long term safety of anifrolumab in adult subjects with active systemic lupus erythematosus (TULIP SLE LTE). Accessed February 3, 2025. https://classic.clinicaltrials.gov/ct2/show/NCT02794285 26. ClinicalTrials.gov. Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus (Tulip SC). August 21, 2025. https://clinicaltrials.gov/study/NCT04877691#participation-criteria 27. Furie R, Khamashta M, Merrill JT, et al; CD7073 Study Investigators. Anifrolumab, an anti-interferon-α receptor monoclonal antibody, in moderate-to-severe systemic lupus erythematosus. Arthritis Rheumatol. 2017;69(2):376-386. 28. Manzi S, Bruce IN, Morand EF, et al: TULIP-SC Investigators. Efficacy and safety of subcutaneous anifrolumab in systemic lupus erythematosus: a randomized, phase 3 study. Arthritis Rheumatol. Published online December 29, 2025. doi:10.1002/art.70041
References: 1. Sammaritano LR, Askanase A, Bermas BL, et al. 2025 American College of Rheumatology (ACR) Guideline for the Treatment of Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). Published online November 3, 2025. doi:10.1002/acr.25690 2. Fanouriakis A, Kostopoulou M, Andersen J, et al. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024;83(1):15-29. 3. van Vollenhoven RF, Bertsias G, Doria A, et al. 2021 DORIS definition of remission in SLE: final recommendations from an international task force. Lupus Sci Med. 2021;8:e000538.
Reference: 1. SAPHNELO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.
CONTRAINDICATION
Known history of anaphylaxis with SAPHNELO.
WARNINGS AND PRECAUTIONS
- Serious Infections: Serious and sometimes fatal infections have occurred in patients receiving immunosuppressive agents, including SAPHNELO. SAPHNELO increases the risk of respiratory infections and herpes zoster. Use caution in patients with severe or chronic infections. Avoid initiating treatment during an active infection and consider interrupting therapy in patients who develop a new infection during treatment
- Hypersensitivity Reaction Including Anaphylaxis: Serious hypersensitivity reactions (including anaphylaxis) have been reported following SAPHNELO administration. Events of angioedema have also been reported. Other hypersensitivity reactions and infusion-related reactions have occurred following administration of SAPHNELO. SAPHNELO should be administered by healthcare providers prepared to manage hypersensitivity reactions, including anaphylaxis and infusion-related reactions, if they occur. Immediately interrupt administration and initiate appropriate therapy if a serious infusion-related or hypersensitivity reaction (eg, anaphylaxis) occurs
- Malignancy: There is an increased risk of malignancies with the use of immunosuppressants. The impact of SAPHNELO on the potential development of malignancies is not known
- Immunization: Avoid the use of live or live-attenuated vaccines in patients treated with SAPHNELO
- Use With Biologic Therapies: SAPHNELO is not recommended for use in combination with other biologic therapies, including B-cell targeted therapies
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥5%) are nasopharyngitis, upper respiratory tract infections, bronchitis, infusion-related reactions, herpes zoster and cough.
In the controlled clinical trials, the incidence of infusion-related reactions was 9.4% in patients while on treatment with SAPHNELO and 7.1% in patients on placebo. Infusion-related reactions were mild to moderate in intensity; the most common symptoms were headache, nausea, vomiting, fatigue, and dizziness.
USE IN SPECIFIC POPULATIONS
Pregnancy: A pregnancy exposure registry monitors pregnancy outcomes in women exposed to SAPHNELO during pregnancy. For more information about the registry or to report a pregnancy while on SAPHNELO, contact AstraZeneca at 1-877-693-9268.
There are insufficient data on the use of SAPHNELO in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. Advise female patients to inform their healthcare provider if they intend to become pregnant during therapy, suspect they are pregnant or become pregnant while receiving SAPHNELO.
Lactation: No data are available regarding the presence of SAPHNELO in human milk, the effects on the breastfed child, or the effects on milk production.
Pediatric Use: The safety and efficacy of SAPHNELO in pediatric patients less than 18 years of age has not been established.
INDICATION
SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.
Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use is not recommended in these situations.
INDICATION
SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy.
Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use is not recommended in these situations.
Please see full Prescribing Information, including Patient Information.
You may report side effects related to AstraZeneca products.Opens new window .
References: 1. Morand EF, van Vollenhoven R, Furie RA, et al. LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials. Supplementary appendix. Ann Rheum Dis. 2025;84(5):777-788. 2. SAPHNELO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. 3. Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020;382(3):211-221. 4. Furie RA, Morand EF, Bruce IN, et al; TULIP-1 Study Investigators. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019;1(4):e208-e219. 5. US Department of Health and Human Services Food and Drug Administration. Guidance for Industry systemic lupus erythematosus—Developing medical products for treatment. Updated June 5, 2020. Accessed April 21, 2026. https://www.fda.gov/media/71150/download
References: 1. Thong B, Olsen NJ. Systemic lupus erythematosus diagnosis and management. Rheumatology (Oxford). 2017;56(suppl1):i3-i13. 2. Allen ME, Rus V, Szeto GL. Leveraging heterogeneity in systemic lupus erythematosus for new therapies. Trends Mol Med. 2021;27(2):152-171. 3. Bertsias G, Cervera R, Boumpas DT. Systemic lupus erythematosus: pathogenesis and clinical features. In: Bijlsma J (ed). EULAR Textbook on Rheumatic Diseases. London: BMJ Group; 2012:476-505. 4. Kaul A, Gordon C, Crow MK, et al. Systemic lupus erythematosus. Nat Rev Dis Primers. 2016;2:16039. 5. Izmirly PM, Parton H, Wang L, et al. Prevalence of systemic lupus erythematosus in the United States: estimates from a meta-analysis of the Centers for Disease Control and Prevention National Lupus Registries. Arthritis Rheumatol. 2021;73(6):991-996. 6. Mauri C, Menon M. The many faces of type I interferon in systemic lupus erythematosus. J Clin Invest. 2015;125(7):2562-2564. 7. Niewold TB, Clark DN, Salloum R, Poole BD. Interferon alpha in systemic lupus erythematosus. J Biomed Biotechnol. 2010;2010:948364. 8. Crow MK. Type I interferon in the pathogenesis of lupus. J Immunol. 2014;192(12):5459-5468. 9. Lauwerys BR, Ducreux J, Houssiau FA. Type I interferon blockade in systemic lupus erythematosus: where do we stand? Rheumatology (Oxford). 2014;53(8):1369-1376. 10. Hoffman RW, Merrill JT, Alarcón-Riquelme MME, et al. Gene expression and pharmacodynamic changes in 1,760 systemic lupus erythematosus patients from two phase III trials of BAFF blockade with tabalumab. Arthritis Rheumatol. 2017;69(3):643-654. 11. Becker AM, Dao KH, Han BK, et al. SLE peripheral blood B cell, T cell and myeloid cell transcriptomes display unique profiles and each subset contributes to the interferon signature. PLoS One. 2013;8(6):e67003. 12. Jefferies CA. Regulating IRFs in IFN driven disease. Front Immunol. 2019;10:325. 13. Mai L, Asaduzzaman A, Noamani B, et al. The baseline interferon signature predicts disease severity over the subsequent 5 years in systemic lupus erythematosus. Arthritis Res Ther. 2021;23(1):29.
References: 1. SAPHNELO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. 2. Mullard A. FDA approves AstraZeneca’s anifrolumab for lupus. Nat Rev Drug Discov. 2021;20(9):658. doi:10.1038/d41573-021-00139-y. 3. Crow MK, Olferiev M, Kirou KA. Type I interferons in autoimmune disease. Annu Rev Pathol. 2019;14:369-393. 4. Wahren-Herlenius M, Dörner T. Immunopathogenic mechanisms of systemic autoimmune disease. Lancet. 2013;382(9894):819-831. 5. Morawski PA, Bolland S. Expanding the B cell-centric view of systemic lupus erythematosus. Trends Immunol. 2017;38(5):373-382. 6. Crow MK. Type I interferon in the pathogenesis of lupus. J Immunol. 2014;192(12):5459-5468. 7. Rönnblom L, Leonard D. Interferon pathway in SLE: one key to unlocking the mystery of the disease. Lupus Sci Med. 2019;6(1):e000270.
References: 1. Ohmura K. Which is the best SLE activity index for clinical trials? Mod Rheumatol. 2021;31(1):20-28. 2. SAPHNELO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025. 3. Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020;382(3):211-221. 4. Furie RA, Morand EF, Bruce IN, et al; TULIP-1 Study Investigators. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019;1(4):e208-e219. 5. Morand EF, Furie RA, Bruce IN, et al. Efficacy of anifrolumab across organ domains in patients with moderate-to-severe systemic lupus erythematosus: a post-hoc analysis of pooled data from the TULIP-1 and TULIP-2 trials. Lancet Rheumatol. 2022;4(4):e282-e292. 6. Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus. Supplementary appendix and Protocol. N Engl J Med. 2020;382(3):211-221. 7. Mikdashi J, Nived O. Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research. Arthritis Res Ther. 2015;17(1):183. 8. Furie RA, Morand EF, Bruce IN, et al; TULIP-1 Study Investigators. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Supplementary appendix. Lancet Rheumatol. 2019;1(4):e208-e219. 9. Morand EF, van Vollenhoven R, Furie RA, et al. LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials. Ann Rheum Dis. 2025;84(5):777-788. 10. Data on File, REF-215956. AstraZeneca Pharmaceuticals LP. 11. US Department of Health and Human Services Food and Drug Administration. Guidance for Industry systemic lupus erythematosus—Developing medical products for treatment. Updated June 5, 2020. Accessed March 19, 2025. https://www.fda.gov/media/71150/download 12. Mosca M, Amoura Z, Weinmann-Menke J, et al. Attainment of LLDAS and DORIS remission during anifrolumab treatment: interim results from a multinational, observational, post-launch study of treatment effectiveness in the real world. Abstract presented at: European Congress of Rheumatology (EULAR) 2025; June 11-14, 2025; Barcelona, Spain. 13. Mosca M, Emmas C, Nekeman-Nan C, et al. Anifrolumab Study for Treatment Effectiveness in the Real World ASTER among patients with systemic lupus erythematosus, protocol for an international observational effectiveness study. BMJ Open. 2024;14(11):e086055. 14. Morand EF, van Vollenhoven R, Furie RA, et al. LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials. Supplementary appendix. Ann Rheum Dis. 2025;84(5):777-788. 15. Data on File, REF-173552. AstraZeneca Pharmaceuticals LP. 16. Kalunian KC, Furie R, Morand EF, et al. A randomized, placebo-controlled phase III extension trial of the long-term safety and tolerability of anifrolumab in active systemic lupus erythematosus. Arthritis Rheumatol. 2023;75(2):253-265. 17. Data on File, REF-173556. AstraZeneca Pharmaceuticals LP. 18. Kalunian KC, Furie R, Morand EF, et al. A randomized, placebo-controlled phase III extension trial of the long-term safety and tolerability of anifrolumab in active systemic lupus erythematosus. Supplementary appendix. Arthritis Rheumatol. 2023;75(2):253-265. 19. Kyttaris V, Atefi G, Persons D, Withrow D, Binka M. Reduction in oral corticosteroid use during anifrolumab therapy: observations from a real-world cohort of adults with systemic lupus erythematosus. Poster presented at: ACR Convergence 2024; November 14-19, 2024; Washington, DC. Poster 2438. 20. Kyttaris V, Binka M, Atefi G, et al. Renal outcomes in patients treated with anifrolumab for systemic lupus erythematosus in the US: findings from a real-world study. Poster presented at: European Alliances of Associations for Rheumatology (EULAR) 2024 European Congress of Rheumatology (ECR) Conference; June 12-15, 2024; Vienna, Austria. Poster POS1067. 21. Touma Z, Bruce IN, Furie R, et al. Reduced organ damage accumulation in adult patients with SLE on anifrolumab plus standard of care compared to real-world external controls. Ann Rheum Dis. 2025;84(5):767-776. 22. Touma Z, Bruce IN, Furie R, et al. Treatment with anifrolumab prevents long-term cardiovascular damage accrual compared with real-world standard of care in patients with systemic lupus erythematosus: findings from the LASER study. Abstract presented at ACR 2025. 23. Gladman D, Ginzler E, Goldsmith C, et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum. 1996;39(3):363-369. 24. ClinicalTrials.gov Trial NCT02446912. Efficacy and safety of two doses of anifrolumab compared to placebo in adult subjects with active systemic lupus erythematosus. Accessed April 27, 2025. https://clinicaltrials.gov/study/NCT02446912 25. ClinicalTrials.gov Trial NCT02794285. Long term safety of anifrolumab in adult subjects with active systemic lupus erythematosus (TULIP SLE LTE). Accessed February 3, 2025. https://classic.clinicaltrials.gov/ct2/show/NCT02794285 26. ClinicalTrials.gov. Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus (Tulip SC). August 21, 2025. https://clinicaltrials.gov/study/NCT04877691#participation-criteria 27. Furie R, Khamashta M, Merrill JT, et al; CD7073 Study Investigators. Anifrolumab, an anti-interferon-a receptor monoclonal antibody, in moderate-to-severe systemic lupus erythematosus. Arthritis Rheumatol. 2017;69(2):376-386.
References: 1. SAPHNELO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. 2. Kalunian KC, Furie R, Morand EF, et al. A randomized, placebo-controlled phase III extension trial of the long-term safety and tolerability of anifrolumab in active systemic lupus erythematosus. Arthritis Rheumatol. 2023;75(2):253-265. 3. Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020;382(3):211-221. 4. Furie RA, Morand EF, Bruce IN, et al; TULIP-1 study investigators. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019;1(4):e208-e219. 5. Furie R, Khamashta M, Merrill JT, et al; CD1013 Study Investigators. Anifrolumab, an anti–interferon-α receptor monoclonal antibody, in moderate-to-severe systemic lupus erythematosus. Arthritis Rheumatol. 2017;69(2):376-386. 6. Manzi S, Bruce IN, Morand EF, et al; TULIP-SC Investigators. Efficacy and safety of subcutaneous anifrolumab in systemic lupus erythematosus: a randomized, phase 3 study. Arthritis Rheumatol. Published online December 29, 2025. doi:10.1002/art.70041
Reference: 1. SAPHNELO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026.
References: 1. Ohmura K. Which is the best SLE activity index for clinical trials? Mod Rheumatol. 2021;31(1):20-28. 2. SAPHNELO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2026. 3. Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus. N Engl J Med. 2020;382(3):211-221. 4. Furie RA, Morand EF, Bruce IN, et al; TULIP-1 Study Investigators. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Lancet Rheumatol. 2019;1(4):e208-e219. 5. Morand EF, Furie RA, Bruce IN, et al. Efficacy of anifrolumab across organ domains in patients with moderate-to-severe systemic lupus erythematosus: a post-hoc analysis of pooled data from the TULIP-1 and TULIP-2 trials. Lancet Rheumatol. 2022;4(4):e282-e292. 6. Morand EF, Furie R, Tanaka Y, et al; TULIP-2 Trial Investigators. Trial of anifrolumab in active systemic lupus erythematosus. Supplementary appendix and Protocol. N Engl J Med. 2020;382(3):211-221. 7. Mikdashi J, Nived O. Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research. Arthritis Res Ther. 2015;17(1):183. 8. Furie RA, Morand EF, Bruce IN, et al; TULIP-1 Study Investigators. Type I interferon inhibitor anifrolumab in active systemic lupus erythematosus (TULIP-1): a randomised, controlled, phase 3 trial. Supplementary appendix. Lancet Rheumatol. 2019;1(4):e208-e219. 9. Morand EF, van Vollenhoven R, Furie RA, et al. LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials. Ann Rheum Dis. 2025;84(5):777-788. 10. Data on File, REF-215956. AstraZeneca Pharmaceuticals LP. 11. US Department of Health and Human Services Food and Drug Administration. Guidance for Industry systemic lupus erythematosus—Developing medical products for treatment. Accessed January 29, 2026. https://www.fda.gov/media/71150/download 12. Mosca M, Amoura Z, Weinmann-Menke J, et al. Attainment of LLDAS and DORIS remission during anifrolumab treatment: interim results from a multinational, observational, post-launch study of treatment effectiveness in the real world. Abstract presented at: European Congress of Rheumatology (EULAR) 2025; June 11-14, 2025; Barcelona, Spain. 13. Mosca M, Emmas C, Nekeman-Nan C, et al. Anifrolumab Study for Treatment Effectiveness in the Real World (ASTER) among patients with systemic lupus erythematosus: protocol for an international observational effectiveness study. BMJ Open. 2024;14(11):e086055. 14. Morand EF, van Vollenhoven R, Furie RA, et al. LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials. Supplementary appendix. Ann Rheum Dis. 2025;84(5):777-788. 15. Data on File, REF-173552. AstraZeneca Pharmaceuticals LP. 16. Kalunian KC, Furie R, Morand EF, et al. A randomized, placebo-controlled phase III extension trial of the long-term safety and tolerability of anifrolumab in active systemic lupus erythematosus. Arthritis Rheumatol. 2023;75(2):253-265. 17. Data on File, REF-173556. AstraZeneca Pharmaceuticals LP. 18. Kalunian KC, Furie R, Morand EF, et al. A randomized, placebo-controlled phase III extension trial of the long-term safety and tolerability of anifrolumab in active systemic lupus erythematosus. Supplementary appendix. Arthritis Rheumatol. 2023;75(2):253-265. 19. Kyttaris V, Atefi G, Persons D, Withrow D, Binka M. Reduction in oral corticosteroid use during anifrolumab therapy: observations from a real-world cohort of adults with systemic lupus erythematosus. Poster presented at: ACR Convergence 2024; November 14-19, 2024; Washington, DC. Poster 2438. 20. Kyttaris V, Binka M, Atefi G, et al. Renal outcomes in patients treated with anifrolumab for systemic lupus erythematosus in the US: findings from a real-world study. Poster presented at: European Alliances of Associations for Rheumatology (EULAR) 2024 European Congress of Rheumatology (ECR) Conference; June 12-15, 2024; Vienna, Austria. Poster POS1067. 21. Touma Z, Bruce IN, Furie R, et al. Reduced organ damage accumulation in adult patients with SLE on anifrolumab plus standard of care compared to real-world external controls. Ann Rheum Dis. 2025;84(5):767-776. 22. Touma Z, Bruce IN, Furie R, et al. Treatment with anifrolumab prevents long-term cardiovascular damage accrual compared with real-world standard of care in patients with systemic lupus erythematosus: findings from the LASER study. Abstract presented at ACR 2025. 23. Gladman D, Ginzler E, Goldsmith C, et al. The development and initial validation of the Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index for systemic lupus erythematosus. Arthritis Rheum. 1996;39(3):363-369. 24. ClinicalTrials.gov Trial NCT02446912. Efficacy and safety of two doses of anifrolumab compared to placebo in adult subjects with active systemic lupus erythematosus. Accessed April 27, 2025. https://clinicaltrials.gov/study/NCT02446912 25. ClinicalTrials.gov Trial NCT02794285. Long term safety of anifrolumab in adult subjects with active systemic lupus erythematosus (TULIP SLE LTE). Accessed February 3, 2025. https://classic.clinicaltrials.gov/ct2/show/NCT02794285 26. ClinicalTrials.gov. Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus (Tulip SC). August 21, 2025. https://clinicaltrials.gov/study/NCT04877691#participation-criteria 27. Furie R, Khamashta M, Merrill JT, et al; CD7073 Study Investigators. Anifrolumab, an anti-interferon-α receptor monoclonal antibody, in moderate-to-severe systemic lupus erythematosus. Arthritis Rheumatol. 2017;69(2):376-386. 28. Manzi S, Bruce IN, Morand EF, et al: TULIP-SC Investigators. Efficacy and safety of subcutaneous anifrolumab in systemic lupus erythematosus: a randomized, phase 3 study. Arthritis Rheumatol. Published online December 29, 2025. doi:10.1002/art.70041
References: 1. Sammaritano LR, Askanase A, Bermas BL, et al. 2025 American College of Rheumatology (ACR) Guideline for the Treatment of Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). Published online November 3, 2025. doi:10.1002/acr.25690 2. Fanouriakis A, Kostopoulou M, Andersen J, et al. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024;83(1):15-29. 3. van Vollenhoven RF, Bertsias G, Doria A, et al. 2021 DORIS definition of remission in SLE: final recommendations from an international task force. Lupus Sci Med. 2021;8:e000538.
Reference: 1. SAPHNELO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024.