Upadacitinib Is Safe and Effective for Crohn’s Disease: Real-World Data from a Tertiary Center

Landscape of new drugs and targets in inflammatory bowel disease

“… 80 Sporadic pulmonary embolism and venous thromboembolic events have been described with upadacitinib, but some of these patients had thromboembolic risk factors and these events cannot be considered with certainty as a side effect of treatment given the inherent risk associated with IBD. 58 , 65 , 81 JAK inhibitors were also associated with increases in serum lipid levels possibly interfering with the risk of MACE. However, these changes are dose‐dependent, reversible, generally complied the ratio total/high‐density lipoprotein cholesterol and not related to a higher risk of MACE in a pooled analysis of 22 RCT assessing JAK inhibitors.…”

“…While upadacitinib, as induction therapy, did not achieve a significantly greater rate of clinical remission than PBO at week 16, endoscopic remission (which was the co‐primary endpoint) and key secondary endpoints were observed with the dose of upadacitinib 24 mg twice daily group (22% of endoscopic remission vs. 0% on PBO; p < 0.01) 51 . In addition, two recent real‐world studies showed promising results with upadacitinib (with a decrease in faecal calprotectin already 2 weeks after initiation) in treatment‐refractory CD patients 64,65 . Phase 3 studies are currently underway in CD 66–68 as well as studies evaluating long‐term efficacy, safety, and tolerability of repeated administration of upadacitinib in UC and CD subjects are currently in progress 69,70…”

“…with upadacitinib, but some of these patients had thromboembolic risk factors and these events cannot be considered with certainty as a side effect of treatment given the inherent risk associated with IBD. 58,65,81 JAK inhibitors were also associated with increases in serum lipid levels possibly interfering with the risk of MACE.…”

“… 82 Other commonly reported side effects include arthralgia, nasopharyngitis and increases in creatine phosphokinase. 58 , 61 , 65 , 83 There are also concerns about the testicular toxicity of filgotinib and its impact on sperm count, warranting dedicated studies (MANTA and MANTA‐Ray). 51 However, preliminary data appear reassuring and show that at week 13, 6.7% of filgotinib‐treated patients and 8.3% of PBO‐treated patients had ≥50% decline in sperm concentration, out of a total of 248 randomised patients followed‐up for active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and non‐radiographic axial spondyloarthritis).…”

“…However, these changes are dose‐dependent, reversible, generally complied the ratio total/high‐density lipoprotein cholesterol and not related to a higher risk of MACE in a pooled analysis of 22 RCT assessing JAK inhibitors 82 . Other commonly reported side effects include arthralgia, nasopharyngitis and increases in creatine phosphokinase 58,61,65,83 . There are also concerns about the testicular toxicity of filgotinib and its impact on sperm count, warranting dedicated studies (MANTA and MANTA‐Ray) 51 .…”