Saxenda and Autoimmune Disease: What Clinicians and Patients Need to Know

At a glance

  • Autoimmune contraindication / None listed in the Saxenda label [1]
  • Label contraindications / Personal or family history of MTC or MEN 2; serious hypersensitivity [1]
  • What the label covers / Contraindications, warnings and oral-medicine absorption; research links obesity with several autoimmune conditions [1][2]
  • Pancreatitis / Label says to discontinue Saxenda if pancreatitis is suspected [1]
  • Nausea / 39.3% vs 13.8% on placebo in adult trials [1]
  • Oral medicines / Saxenda delays gastric emptying; the label advises monitoring for effects on oral medicines [1]

Does the Saxenda label list autoimmune disease as a contraindication?

No. The contraindications section lists two things: a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), and a serious hypersensitivity reaction to liraglutide or any excipient [1]. No autoimmune condition appears there. Saxenda is liraglutide 3 mg, a once-daily injected GLP-1 receptor agonist used for weight management alongside a reduced-calorie diet and more physical activity [1].

What warnings in the label matter most?

Pancreatitis. Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing cases, has been observed with GLP-1 receptor agonists including liraglutide [1]. The label says to discontinue Saxenda if pancreatitis is suspected [1].

Thyroid C-cell tumors. Liraglutide caused dose- and duration-dependent thyroid C-cell tumors in rats and mice at clinically relevant exposures; whether it does so in humans is unknown [1]. The label says routine calcitonin testing or thyroid ultrasound is of uncertain value, citing low test specificity and a high background incidence of thyroid disease [1]. Separately, a review describes the thyroid as the organ most often affected by autoimmune disease [3].

Gastrointestinal effects. In the adult trials, nausea occurred in 39.3% versus 13.8% on placebo, diarrhea in 20.9% versus 9.9%, constipation in 19.4% versus 8.5%, and vomiting in 15.7% versus 3.9%; 9.8% versus 4.3% stopped treatment because of adverse reactions [1]. The label says Saxenda is not recommended in people with severe gastroparesis [1].

Heart rate. Resting heart rate rose by a mean of 2 to 3 bpm, and 34% versus 19% had a rise of more than 10 bpm at two consecutive visits [1].

Why does obesity matter in autoimmune disease?

A systematic review of 329 articles found the strongest evidence linking obesity to higher risk of rheumatoid arthritis (odds ratio 1.2 to 3.4), multiple sclerosis (odds ratio 2), and psoriasis and psoriatic arthritis (odds ratio 1.48 to 6.46) [2]. The same review reported that obesity worsens the course of RA, SLE, IBD, psoriasis and psoriatic arthritis [2].

What about oral medicines used for autoimmune disease?

The label says Saxenda delays gastric emptying and may therefore affect absorption of oral medicines. It also says liraglutide did not affect the absorption of the oral medicines tested in clinical pharmacology trials to a clinically relevant degree, and that patients should be monitored for consequences of delayed absorption [1]. That section names no specific medicine, so it gives no separate instruction for methotrexate, mycophenolate, tacrolimus or cyclosporine [1].

Frequently asked questions

Does Saxenda have any contraindication in autoimmune disease?
The Saxenda label lists two contraindications: a personal or family history of medullary thyroid carcinoma or MEN 2, and serious hypersensitivity to liraglutide or an excipient. Autoimmune disease is not one of them [1].
Does Saxenda interact with methotrexate or other oral immunosuppressants?
The label says Saxenda delays gastric emptying, that the oral medicines tested were not affected to a clinically relevant degree, and that patients should be monitored for consequences of delayed absorption. It names no specific medicine [1].
Why does obesity come up in autoimmune disease?
A systematic review of 329 articles found obesity linked to higher risk of rheumatoid arthritis, multiple sclerosis, and psoriasis and psoriatic arthritis, and reported that obesity worsens the course of RA, SLE, IBD and psoriasis [2].
How common are stomach side effects on Saxenda?
In adult trials: nausea 39.3% versus 13.8% on placebo, diarrhea 20.9% versus 9.9%, constipation 19.4% versus 8.5%, vomiting 15.7% versus 3.9%. Treatment was stopped for adverse reactions by 9.8% versus 4.3% [1].

References

  1. U.S. National Library of Medicine, DailyMed. Saxenda injection (liraglutide) prescribing information. Saxenda injection (liraglutide) label
  2. Versini M, Jeandel PY, Rosenthal E, Shoenfeld Y. Obesity in autoimmune diseases: not a passive bystander. Autoimmun Rev. 2014;13(9):981-1000. Obesity in autoimmune diseases: not a passive bystander
  3. McLeod DS, Cooper DS. The incidence and prevalence of thyroid autoimmunity. Endocrine. 2012;42(2):252-65. The incidence and prevalence of thyroid autoimmunity
Evidence overview for Saxenda and Autoimmune Disease: What Clinicians and Patients Need to Know