In a multicenter clinical study, 120 patients with UC(ulcerative colitis) were randomly divided into two groups, one group received Adacolumn apheresis, the other group received conventional drugs. The drug therapy was in accordance with the Guidelines of the Investigation and Research Committee of Inflammatory Bowel Disease of the Ministry of Health and Welfare of japan (1988). Patients in the Adacolumn group received one apheresis per week for 5 consecutive weeks. Two weeks after the last apheresis, efficacy and safety (usefulness) of both therapies were assessed. The figure shows that apheresis therapy is superior to conventional drugs and this is more striking in severe and intractable cases.

• Female, 25 years old, first attack in July 1990, continued steroid medication.
• After the fourth relapse in July 1995, the patient ceased steroid therapy, but received Adacolumn apheresis, one apheresis per week for 5 consecutive weeks.
• Prior to apheresis therapy, she had 9 bloody stools per day plus abdominal pain.
• After the first apheresis, bloody stool and abdominal pain ceased.
• After the 5th apheresis, ulcer, easily bleeding on contact and multiple erosions disappeared.
• Subsequently, a vascular pattern was observed followed by complete remission.

Currently, Adacolumn is manufactured and is being sold as a medical device for treating ulcerative colitis in Japan. Safety of the Adacolumn apheresis was assessed in 286 Japanese patients, 59 with UC and 227 with RA. In UC, adverse reactions were observed in 5 of 59 patients (8.5%). Typical adverse reactions were dizziness on standing, dizziness, nausea, headache, flushing and mild fever. Abnormal clinical laboratory test values, S-GPT, S-GOT, γ-GTP, α1-globulin, α2-globulin, β-globulin, γ-globulin, BUN, K, TP, Alb, Al-p, LDH, total cholesterol, Na, Cl and urine protein were observed in 27 of 59 patients (45.8%), but a definite association with Adacolumn was not assumed. α1-globulin, α2-globulin, β-globulin and γ-globulin were the most frequently observed abnormal clinical laboratory test values, not uncommon in patients with UC.

In the 56 control patients with UC who were treated with conventional drugs, a total of 40 adverse reactions (24 of 56 patients, 42.9%) were observed, significantly (P<0.001) higher than in Adacolumn apheresis group. Most common adverse reactions to drug therapy included skeletal disorders, moon face and acne which are typical adverse reactions associated with steroids. Abnormal clinical laboratory test results, which could have a causal relationship with the drug therapy were seen in 6 patients (10.7%), and with unclear causal relationship in 20 patients (35.7%). Further, 3 patients in the control group discontinued drug therapy due to severe adverse reactions. In contrast, all adverse reactions to Adacolumn apheresis were mild; patients recovered without medication and no patient discontinued apheresis therapy due to adverse event.

Regarding RA, headache, hypotension during apheresis, nausea, palpitation, fatigue were reported as adverse reactions by 4 (1.8%) of 227 patients. Further, abnormal clinical laboratory test results: rises in GOT, GPT, γ-GTP, Al-P, LDH or decreases in total protein, albumin, albumin/globulin, Ca were seen in 7 of 227 patients. However, an association between these abnormal clinical laboratory test values and Adacolumn apheresis was “unclear”.

In summary, adverse reactions and abnormal clinical laboratory test results were seen in a total of 35 of 286 patients (12.2%). Evaluation of these adverse reactions indicated that Adacolumn apheresis has an excellent safety feature.