No statistical significance but a numerical difference found
“The primary outcome, which was change in mSASSS score, clearly shows a numerical difference between the combination arm at 1.1 and the monotherapy arm at 1.7 points, showing more structural progression in the monotherapy arm, compared to the combination arm,” Dr. Proft reported. However, he stressed that this difference did not reach statistical significance.
New syndesmophytes occurred in 25% with monotherapy and 11.1% with combination treatment. Again, this difference did not reach statistical significance.
“This might be due to sample size but also to the length of follow-up because a longer follow-up [given structural changes occur relatively slowly] might have shown a greater difference,” Dr. Proft pointed out.
Clinical data, according to Ankylosing Spondylitis Disease Activity Score with CRP and BASDAI, showed that both groups responded very well to therapy, and there were no differences seen between the two groups in terms of clinical parameters.
“It is important when we add a drug – and we know that NSAIDs can have safety concerns – that we do not see any statistically significant serious adverse events between patient groups,” Dr. Proft noted.
There were no significant differences in adverse events between monotherapy and combination therapy. There were 162 infections in the combination arm and 150 in the monotherapy arm. Combination therapy led to seven serious adverse events, and monotherapy occurred with five adverse events.
Dr. Proft added that four patients discontinued in the combination arm, compared with only one in the monotherapy arm, with a variety of different reasons for the discontinuations.
The study was supported by a grant from the German Ministry of Education and Research, and golimumab was provided free of charge by Merck Sharp & Dohme. Dr. Proft reported serving on speakers bureaus for Amgen, AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, and UCB; serving as a consultant to Novartis; and receiving grant or research support from Novartis, UCB, and Lilly. Dr. Maksymowych declared having no relevant conflicts of interest.