Golimumab (symponi) is the latest addition to TNF-α blocking drugs for inflammatory bowel diseases (IBD) such as ulcerative colitis (UC). A summary of all available safety and efficacy data on the drug was recently published in the journal Drug, Healthcare and Patient Safety, concluding the face that golimumab presents a valid treatment option for UC patients refractory (resistant) to treatment.
The review, “Benefit-risk assessment of golimumab in the treatment of refractory ulcerative colitis,“ was performed by Daniela Pugliese and colleagues from Catholic University in Rome, Italy.
Two earlier TNF-α blockers used for UC have been on the market for about 15 years, and while they have revolutionized treatment for many patients, an estimated 25 percent of patients are refractory to any available treatment, being left with colectomy as their only choice.
The new addition to the TNF-α blocking drug class differs from its predecessors by being an entirely humanized antibody that is more stable and binds strongly to TNF-α. The treatment regimen consists of an induction phase of higher doses for the first weeks, and a maintenance phase of 50 or 100 mg every four weeks.
A number of clinical trials have investigated the efficiency and safety of both induction and maintenance phases of the treatment. The trials studying the induction phase found that only the quality of life was improved after a six-week treatment, while no improvements were observed in clinical outcomes.
A study of the maintenance phase of golimumab therapy included only the patients who had responded to treatment in the induction study and who were re-randomized to either golimumab treatment or placebo. The main outcome measure of the study was a continuous clinical response, defined as maintenance of constant benefits, without relapse, over 54 weeks.
This goal was achieved in 49.7 percent of the patients receiving 100 mg, and in 47 percent of patients who received 50 mg of golimumab, compared to only 31.2 percent receiving placebo. More patients in the active treatment group also achieved clinical remission and healing of the intestinal mucosa, compared to placebo.
A further analysis of the trial results showed that patients that achieved 54 weeks with maintained benefits were more likely to have better clinical outcomes, such as the ability to stop treatment with steroids, reach clinical remission or report improved quality of life.
According to study findings, patients that did not improve on 50 mg golimumab showed little evidence of improvement also after switching to 100 mg. The development of antibodies against the treatment was lower than rates reported for the earlier TNF-α blockers infliximab and adalimumab.
Treatment of UC currently follows an approach with more powerful drugs, with potentially more severe side effects, are added when previous treatment is judged insufficient. Biological drugs, such as TNF-α blockers, are considered a last choice therapy, employed when all other treatments have failed to produce a response or have been poorly tolerated. This is, in large part, due to the high cost of treatment.
The authors argued, however, that there is little evidence supporting the effectivity of current first line drugs. Considering the evidence of drug efficiency, biological drugs should, therefore, be introduced earlier in the treatment of patients with moderate to severe UC. Such an approach could limit the use of corticosteroids, and be particularly useful for patients who develop dependence.
There is very little data comparing the three TNF-α blockers to each other. No direct comparisons exist, but statistical modeling accounting for different trial designs, suggest that golimumab and infliximab are comparable considering long-term clinical and endoscopic improvement, while golimumab seemed to be superior to adalimumab.
The authors, however, believe that it is too early to issue statements about the supremacy of one TNF-α blocker over the other. Therefore, decisions about which agent to use can be made only based on the clinician’s personal experience along with patient preferences, costs, and safety considerations.
The review also noted that the route of administration should be a choice made by the patients and the treating physician after the patient is informed about all different available options, as well as pros and cons of the treatment. Subcutaneous injections are beneficial for active individuals, and are administered only once per month.
The safety of golimumab is comparable to the two other anti-TNF-α agents – adverse events were experienced in 11 percent of patients, compared to 7.7 percent of individuals receiving placebo. Long-term treatment was also not associated with any increase in serious adverse events, malignancies, serious infection, or injection-site reactions.
In a final note, the authors stated that although golimumab seems to be a valid option for treatment of refractory UC patients, it could be difficult to apply the clinical trial data to patients in a real-life clinical setting, since such population is far more heterogeneous.
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