Table 4

Therapeutic effects of adalimumab in the approved indications in adult patients (FDA and EU drug label)

IndicationStudyConcomitant medicationsEfficacy end pointWeekAdalimumab
Response rate (%)
Placebo response rate (%)Placebo-adjusted response rate (%)
Rheumatoid arthritis*Weinblatt et al10MTXACR2024651352
van de Putte et al11NoneACR2026461927
Keystone et al12MTXACR2052592435
Furst et al13NoneACR2024533518
Psoriatic arthritis*Mease et al14NoneACR2012581444
Genovese et al15NoneACR2012391623
Ankylosing spondylitis*van der Heijde et al16NoneASAS2012582137
Crohn's disease†Hanauer et al17NoneClinical response‡4593722
Sandborn et al18NoneClinical response4523418
Colombel et al19NoneClinical response26542826
Clinical response56431825
Ulcerative colitis†§Reinisch et al20NoneClinical remission¶81899
Sandborn et al21NoneClinical remission81798
Clinical response**52301812
Plaque psoriasis††Menter et al22NonePASI751671764
Saurat et al23NonePASI7516801961
  • *Dosage of adalimumab for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: 40 mg every other week.

  • †Dosage of adalimumab for Crohn's Disease and Ulcerative Colitis: Initial dose (Day 1) is 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a maintenance dose of 40 mg every other week.

  • ‡Clinical response is defined as a decrease in the Crohn's Disease Activity Index ≥70.

  • §Ulcerative colitis is an approved indication for Humira in Europe by the EMA, but not in the USA by the FDA.

  • ¶Clinical remission is defined as Mayo score ≤2 with no subscore >1.

  • **Clinical response is defined as a decrease from baseline in Mayo score ≥3 points and ≥30% plus a decrease in the RBS≥1 or an absolute RBS of 0 or 1.

  • ††Dosage of adalimumab for plaque psoriasis: initial dose is 80 mg, followed by 40 mg every other week starting one week after initial dose.

  • ACR20, 20% improvement in the American College of Rheumatology criteria; ASAS20, 20% improvement in the Assessments in Spondyloarthritis international Society score; EMA, European Medicines Agency; EU, European Union; FDA, Food and Drug Administration; MTX, methotrexate; PASI75, 75% reduction in the Psoriasis Area and Severity Index score; RBS, rectal bleeding subscore.