{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,29]],"date-time":"2026-01-29T23:10:38Z","timestamp":1769728238552,"version":"3.49.0"},"reference-count":16,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2016,5,29]],"date-time":"2016-05-29T00:00:00Z","timestamp":1464480000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2016,8]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>Subcutaneous (s.c.) peginterferon beta\u20101a injected once every 2\u00a0weeks and s.c. interferon beta\u20101a injected three times per week (Rebif\u00ae) have demonstrated efficacy in relapsing\u2013remitting multiple sclerosis, but direct comparisons of pharmacological activity and tolerability between the two products are lacking. COMPARE was an open label, crossover, pharmacokinetic (PK) study evaluating drug exposure and the safety and tolerability of s.c. peginterferon beta\u20101a and s.c. interferon beta\u20101a, over 2\u00a0weeks in healthy subjects.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Thirty healthy subjects received one dose of peginterferon beta\u20101a (125 \u03bcg s.c.) or six doses of interferon beta\u20101a (44 \u03bcg s.c.) over 2\u00a0weeks, followed by the alternate treatment after a 2\u00a0week washout period. Drug concentrations were measured using an enzyme\u2010linked immunosorbent assay (ELISA) and PK parameters including cumulative area under the concentration\u2013time curve (AUC<jats:sub>0\u2010336h<\/jats:sub>) over 2\u00a0weeks and maximum observed serum concentrations (<jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub>) were estimated using a non\u2010compartmental analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The PK analysis population comprised 26 subjects for each treatment. Drug exposure (AUC<jats:sub>0\u2010336h<\/jats:sub>) was 60% higher with s.c. peginterferon than with s.c. interferon beta\u20101a (117.4 ng ml<jats:sup>\u22121<\/jats:sup>h, 95% confidence interval 95.6, 144.3 <jats:italic>vs.<\/jats:italic> 73.1 ng ml<jats:sup>\u22121<\/jats:sup> h, 95% confidence interval 61.2, 87.3, respectively; <jats:italic>P<\/jats:italic> &lt; 0.0001). Injection\u2010site reactions (ISRs) were the most common adverse events (AEs) observed with both treatments. Numerically lower frequencies and incidence rates of ISRs, headache, myalgia and chills were observed with s.c. peginterferon beta\u20101a.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>One dose of s.c. peginterferon delivered significantly greater drug exposure than s.c. interferon beta\u20101a three times a week over 2\u00a0weeks, and a lower frequency of AEs.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.12968","type":"journal-article","created":{"date-parts":[[2016,4,10]],"date-time":"2016-04-10T18:19:17Z","timestamp":1460312357000},"page":"380-388","source":"Crossref","is-referenced-by-count":28,"title":["COMPARE: Pharmacokinetic profiles of subcutaneous peginterferon beta\u20101a and subcutaneous interferon beta\u20101a over 2\u00a0weeks in healthy subjects"],"prefix":"10.1111","volume":"82","author":[{"given":"Xiao","family":"Hu","sequence":"first","affiliation":[{"name":"Biogen  Cambridge MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shulian","family":"Shang","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ivan","family":"Nestorov","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jawad","family":"Hasan","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ali","family":"Seddighzadeh","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katherine","family":"Dawson","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bj\u00f8rn","family":"Sperling","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian","family":"Werneburg","sequence":"additional","affiliation":[{"name":"Biogen  Cambridge MA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,5,29]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(14)70068-7"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/1352458514557986"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.2165\/11596970-000000000-00000"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1021\/bc050237q"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1177\/0091270011407068"},{"key":"e_1_2_9_7_1","unstructured":"Plegridy Prescribing Information. 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