A randomized,controlled,open label non-inferiority trial of intravenous ferric carboxymaltose versus iron sucrose in patients with iron deficiency anemia in China

Iron deficiency(ID)and ID anemia(IDA)pose significant public health concerns in China.Although iron sucrose(IS)treatment is well-established in the country,ferric carboxymaltose(FCM)offers the advantage of higher doses and fewer infusions.This open label,randomized,controlled,non-inferiority trial was conducted at multiple sites in China to compare the outcomes of FCM(maximum of 2 doses,500 or 1000 mg iron)and IS(up to 11 infusions,200 mg iron)treatments in subjects with IDA.The primary endpoint was the achievement of hemoglobin(Hb)response(an increase of⩾2 g/dL from baseline)within 8 weeks,whereas secondary endpoints included changes in Hb,transferrin saturation,and serum ferritin levels.Among the 371 randomized subjects,a similar percentage of subjects treated with FCM and IS achieved Hb-response(FCM 99.4%,IS 98.3%),thereby confirming the non-inferiority of FCM compared with IS(difference 1.12(−2.15,4.71;95%confidence interval(CI))).Furthermore,a significantly higher proportion of FCM-treated subjects achieved early Hb-response at Week 2(FCM 85.2%,IS 73.2%;difference 12.1(3.31,20.65;95%CI)).Additionally,the increase in TSAT and serum ferritin levels from baseline was significantly greater at all time points for FCM-treated subjects.The safety profiles of FCM and IS were comparable,with the exception of transient hypophosphatemia and pyrexia,which are consistent with FCM’s known safety profile.In conclusion,FCM proves to be an efficacious treatment for IDA,providing faster Hb-response and correction of ID with fewer administrations than IS.

New progress of small-molecule drugs in the treatment of inflammatory bowel disease

With the advent of small-molecule drugs,treatment of inflammatory bowel disease(IBD)has reached a new stage.In contrast to biologics,small-molecule drugs can be made into oral dosage forms with a short half-life and are suitable for administration 1–2 times a day.Small-molecule drugs work by inhibiting the transmission of key intracellular signaling pathways in the pathogenesis of ulcerative colitis(UC)and Crohn’s disease(CD)[Figure 1].They do not induce anti-drug antibodies in patients or lead to loss of response after treatment.

Evaluating the effectiveness of infliximab on perianal fistulizing Crohn’s disease by magnetic resonance imaging

Background and aim:Data on the radiologic evaluation of perianal fistulizing Crohn’s disease(PFCD)naive to anti-tumor necrosis factor therapy are scarce,especially in Asian populations.We assessed the effectiveness of infliximab(IFX)on PFCD and explored predictors of‘deep remission’based on clinical and radiologic assessments.Methods:Patients with Crohn’s disease and active anal fistulas attending our care center for IFX therapy were prospectively enrolled.Each patient underwent clinical examination according to the Fistula Drainage Assessment Index,endoscopy for assessment of Crohn’s Disease Activity Index(CDAI)and Perianal Crohn’s Disease Activity Index(PCDAI),magnetic resonance imaging(MRI)to determine Van Assche score and Ng score,and laboratory tests up to 2 weeks prior to the start of and up to 2 weeks after the sixth IFX therapy(Week 32).Results:Among 38 patients treated with IFX,52.6%achieved clinical remission based on the Fistula Drainage Assessment Index and 42.1%achieved deep remission based on Ng score.Van Assche score(from 14.5±4.26 to 7.36±7.53),CDAI(from 170±92 to 71±69)and PCDAI(from 7.45±2.65 to 2.44±3.20)decreased significantly after six IFX treatments.The only predictor of deep remission was simple fistula(P=0.004,odds ratio=3.802,95%confidence interval:1.541–9.383).Conclusions:IFX has been shown to have appreciable effectiveness in Chinese patients with PFCD.MRI is the gold standard for evaluating PFCD,but Van Assche score has some limitations.